Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004823-39 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.
CC-5013-MM020/IFM 07-01 is a Phase III, multicenter, randomized, open-label, 3-arm study that will compare the efficacy and safety of two Lenalidomide plus low-dose dexamethasone regimens given for two different durations of time (i.e., until progressive disease [PD] or for up to a maximum of 18 four-week cycles) to that of MPT given for a maximum of 12 six-week cycles.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenalidomide / Dexamethasone until disease progression | Experimental | Lenalidomide plus low-dose dexamethasone given until disease progression |
|
| Lenalidomide / Dexamethasone for 18 cycles | Experimental | Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles |
|
| Melphalan, Prednisone, and Thalidomide (MPT) for 12 cycles | Active Comparator | Combination of Melphalan, Prednisone and Thalidomide given for 12 six-week cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide and low-dose dexamethasone | Drug | Lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg 20mg, or 25 mg capsules, given either days 1-21 of each 28 day cycles or given every other day for 21 days until documentation of PD. Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle up to disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC) | PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's). | From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months. |
| Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis | PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's). | From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS) | Overall survival was defined as the time between randomization and death. Participants, who died, regardless of the cause of death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the participant was known to be alive. |
Not provided
Inclusion Criteria:
Must understand and voluntarily sign informed consent form
Age ≥ 18 years at the time of signing consent
Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below:
AND have measurable disease by protein electrophoresis analyses as defined by the following:
AND are at least 65 years of age or older or, if younger than 65 years of age, are not candidates for stem cell transplantation because:
ECOG performance status of 0, 1, or 2
Able to adhere to the study visit schedule and other protocol requirements
Females of child-bearing potential (FCBP)^2:
Male Patients:
All patients must:
Exclusion Criteria:
Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]).
Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
Pregnant or lactating females.
Any of the following laboratory abnormalities:
Renal failure requiring hemodialysis or peritoneal dialysis.
Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:
Patients who are unable or unwilling to undergo antithrombotic therapy.
Peripheral neuropathy of > grade 2 severity.
Known HIV positivity or active infectious hepatitis, type A, B, or C. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christian Jacques, MD | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of AL Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Cedar Sinai Medical Center Dept of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26659916 | Background | Dimopoulos MA, Cheung MC, Roussel M, Liu T, Gamberi B, Kolb B, Derigs HG, Eom H, Belhadj K, Lenain P, Van der Jagt R, Rigaudeau S, Dib M, Hall R, Jardel H, Jaccard A, Tosikyan A, Karlin L, Bensinger W, Schots R, Leupin N, Chen G, Marek J, Ervin-Haynes A, Facon T. Impact of renal impairment on outcomes with lenalidomide and dexamethasone treatment in the FIRST trial, a randomized, open-label phase 3 trial in transplant-ineligible patients with multiple myeloma. Haematologica. 2016 Mar;101(3):363-70. doi: 10.3324/haematol.2015.133629. Epub 2015 Dec 11. | |
| 27325857 |
| Label | URL |
|---|---|
| Link to CSR synopsis | View source |
Not provided
Participants were stratified at randomization by 1) age (≤ 75 versus > 75 years), 2) stage (International Staging System Stages I or II versus Stage III), and 3) country.
This study was conducted in the Europe, Asia, North America and Pacific regions. Participants were randomized at 246 sites (165 in Europe, 23 in Asia, 39 in North America, and 19 in the Pacific). The study was co-sponsored by Intergroupe Francophone du Myélome (IFM) (for sites in France, Switzerland, and Belgium) and Celgene Corporation.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lenalidomide and Low-Dose Dexamethasone (Rd) | Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Active Treatment Phase |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles | Drug | lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg, 20 mg or 25 mg capsules given on days 1-21 of each 28 day cycle or every other day for 21 days for 18 cycles. Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle for 18 cycles |
|
|
| Melphalan, Prednisone and Thalidomide | Drug | Melphalan - oral, 2mg tablets dosed at either 0.25mg/kg, 0.125 mg/kg, 0.20mg/kg or 0.10mg/kg on days 1-4 of each 42 day cycle up to 12 cycles Prednisone - oral, 5mg, 10mg, 20 mg and 50 mg tablets dosed at 2mg/kg daily days 1-4 of each 42 day cycle for up to 12 cycles Thalidomide - oral, 50mg, 100mg and 200 mg capsules dosed at either 100mg or 200 mg daily on days 1-41 of each 42 day cycle for up to 12 cycles |
|
|
| From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months |
| Percentage of Participants With an Objective Response Based on IRAC Review | Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined as: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis | Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC | Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first. | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months |
| Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis | Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first. | Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months |
| Time to First Response Based on the Review by the IRAC | The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria. | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| Time to First Response Based on the Investigator Assessment at the Time of Final Analysis | The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria assessed by the investigator. | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm. |
| Kaplan Meier Estimates of Time to Treatment Failure (TTF) | TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by IRAC based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death. | From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 16.1 months. |
| Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis | TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by the investigators assessment based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death. | From date of randomization until the data cut-off date of 21 January 2016; median follow up for all participants was 16.1 months. |
| Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT) | Time to second-line anti-myeloma therapy was defined as time from randomization to the start of another non-protocol anti-myeloma therapy. | From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 23.0 months |
| Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis | Time to second-line anti-myeloma therapy is defined as time from randomization to the start of another non-protocol anti-myeloma therapy. Those who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy. | From date of randomization until the data cut-off of date 21 January 2016; median follow-up for all participants was 23.0 months |
| Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis | Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. | Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review. | Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review | Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review | Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review | Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement. | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Cycle 1 Day 1, (Baseline) then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation |
| Change From Baseline in the EORTC QLQ-C30 Pain Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea/Vomiting Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Scale is scored between 0 and 100, with a high score indicating a higher level of appetite loss. Negative change from Baseline values indicate improvement in appetite and positive values indicate worsening of appetite. | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| Change From Baseline in the EORTC QLQ-C30 Constipation Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Scale is scored between 0 and 100, with a high score indicating a higher level of constipation. Negative change from Baseline values indicate improvement in constipation and positive values indicate worsening of constipation. | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Diarrhea Scale is scored between 0 and 100, with a high score indicating a higher level of diarrhea. Negative change from Baseline values indicate improvement in diarrhea and positive values indicate worsening of diarrhea. | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Difficulties Scale is scored between 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicate improvement in financial difficulties and positive values indicate worsening of financial difficulties. | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score indicates more severe disease symptom(s). | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment. | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the future perspective scale, a higher score indicates a better perspective of the future. | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the body image scale, a higher score indicates a better body image. | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | EQ-5D is a self-administered questionnaire that assesses health-related quality of life. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where higher EQ-5D scores represent better health status. A positive change from baseline score indicates improvement in health status and better health state. | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year | HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of inpatient hospitalizations per patient year was calculated as the total number of hospitalizations divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient. | Day 1 (randomization) up to last visit completed 25 July 2016 |
| Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | A TEAE is any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. | From first dose of study drug through 28 days following the discontinuation visit from active treatment phase; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | Renal function was assessed for participants from baseline to the most extreme value in creatinine clearance calculated using the Cockcroft-Gault estimation. | Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Neutrophil counts was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. | Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Hemoglobin was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. | Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Improvement in platelets was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. | Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| Improvement of Infection Rate by Observing the Historical Data Compared to the Clinical Data Base | Improvement of infection rate by observing historical data compared to the data within clinical database as not analyzed. | From randomization to 24 May 2013 |
| Los Angeles |
| California |
| 90048 |
| United States |
| University of California, San Francisco- California | San Francisco | California | 94143 | United States |
| Stanford University Stanford | Stanford | California | 94305 | United States |
| Gainesville Heme Oncology Associates | Gainesville | Florida | 32607 | United States |
| Baptist Cancer Institute | Jacksonville | Florida | 32207 | United States |
| Integrated Community Oncology Network | Orange Park | Florida | 32073 | United States |
| Gulf Coast Oncology | St. Petersburg | Florida | 33705 | United States |
| Palm Beach Cancer Institute, LLC | West Palm Beach | Florida | 33401 | United States |
| Southern Illinois Hematology Oncology | Centralia | Illinois | 62801 | United States |
| Orchard Healthcare Research, Inc. | Chicago | Illinois | 60611 | United States |
| John H Stroger Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Ingalls Cancer Institute | Harvey | Illinois | 60426-3558 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67124 | United States |
| Maine Center for Cancer Medicine Blood Disorders | Scarborough | Maine | 04074 | United States |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Billings Clinic | Billings | Montana | 59107 | United States |
| Arena Oncology Associates, PC | Lake Success | New York | 11042 | United States |
| Dakota Cancer Institute | Fargo | North Dakota | 58103 | United States |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Kaiser Permanente Northwest Oncology Hematology | Portland | Oregon | 97227 | United States |
| St. Luke's Hospital and Health Network | Allentown | Pennsylvania | 18104 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| The Cancer Center | Collierville | Tennessee | 38017 | United States |
| University of Tennessee Cancer Institute | Memphis | Tennessee | 38104 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0561 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology | East Melbourne | Victoria | 3002 | Australia |
| Western Hospital | Footscray | Victoria | 3011 | Australia |
| Frankston Hospital | Frankston | Victoria | 3199 | Australia |
| Flinders Medical Centre | Bedford Park | 5042 | Australia |
| Geelong Hospital | Geelong | 3220 | Australia |
| Gosford Hospital | Gosford | 2250 | Australia |
| Royal Brisbane and Women's Hospital | Herston | 4029 | Australia |
| Cabrini Hospital | Malvern | 3144 | Australia |
| The Royal Melbourne Hospital | Parkville | 3050 | Australia |
| Royal Perth Hospital | Perth | 6000 | Australia |
| Gold Coast Hospital | Southport | 4215 | Australia |
| Royal North Shore Hospital | St Leonards | 2065 | Australia |
| Westmead Hospital | Wentworthville | 2145 | Australia |
| Border Medical Oncology | Wodonga | 3690 | Australia |
| Wollongong Hospital | Wollongong | 2500 | Australia |
| Princess Alexandra Hospital | Woolloongabba | 4102 | Australia |
| Hospital Leoben | Leoben | 8700 | Austria |
| Hospital of Barmherzige Schwestern Linz | Linz | 4010 | Austria |
| Hospital of Elisabethinen Linz | Linz | 4010 | Austria |
| General Hospital Linz | Linz | 4021 | Austria |
| MM-015. Salzburger Landkliniken, St. Johanns-Spital, Universitätsklinik fur Innere Medizin III | Salzburg | 5020 | Austria |
| Hospital St. Polten | Sankt Pölten | 3100 | Austria |
| Hospital of the Barmherzigen Bruder Vienna | Vienna | 1020 | Austria |
| MM-015.Wihelminenspital | Vienna | 1160 | Austria |
| MM-015. Medizinische Universität Wien | Vienna | A-1090 | Austria |
| Hospital Wels | Wels | 4600 | Austria |
| Hospital Wiener Neustadt | Wiener Neustadt | Austria |
| ZNA Stuivenberg Centrumziekenhuis | Antwerp | 2069 | Belgium |
| Les Cliniques du Sud Luxembourg | Arlon | 6700 | Belgium |
| AZ St-Jan Brugge Oostende AV | Bruges | 8000 | Belgium |
| Jules Bordet Institut | Brussels | 1000 | Belgium |
| Hopital Erasme | Brussels | 1070 | Belgium |
| AZ-VUB | Brussels | 1090 | Belgium |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| Virga Jesse Ziekenhuis | Hasselt | 3500 | Belgium |
| Universitair Ziekenhuis Leuven, Campus Gasthuisberg | Leuven | 3000 | Belgium |
| H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat | Roeselare | 8800 | Belgium |
| Cliniques Universitaires UCL de Mont-Godine | Yvoir | 5530 | Belgium |
| University of Calgary | Calgary | Alberta | T2N 2T9 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| British Columbia Cancer Agency | Kelowna | British Columbia | V1Y 5L3 | Canada |
| Royal Columbian Hospital | New Westminster | British Columbia | V3M 1X4 | Canada |
| BC Cancer Agency - Fraser Valley Centre | Surrey | British Columbia | V3V 1Z2 | Canada |
| Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Vancouver Island Cancer Center | Victoria | British Columbia | V8R 6V5 | Canada |
| Saint John Regional Hospital | Saint John | New Brunswick | E2L 3L6 | Canada |
| Queen Elizabeth II Health Sciences Center | Halifax | Nova Scotia | B3H2Y9 | Canada |
| Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada |
| London Health Science Centre | London | Ontario | N6A 4G5 | Canada |
| Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Hospital Charles LeMoyne | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Hopital de la Cite-de-la-Sante | Laval | Quebec | H7M 3L9 | Canada |
| Hotel-Dieu de Levis | Lévis | Quebec | G5V 3Z1 | Canada |
| Hopital du Sacre-Coeur de Montreal | Montreal | Quebec | G4H 1C5 | Canada |
| Hospital Maisonneuve - Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| CHUM- Hopital Notre-Dame | Montreal | Quebec | H2L4M1 | Canada |
| McGill University | Montreal | Quebec | H2W 1S6 | Canada |
| Sir Mortimer B. Davis - Jewish Genl | Montreal | Quebec | H3T 1E2 | Canada |
| CHUQ - Hotel-Dieu de QuebecHematology - Oncology | Québec | G1R 2J6 | Canada |
| Chaoyang Hospital | Beijing | 100020 | China |
| Peking University People's Hospital | Beijing | 100044 | China |
| West China Hospital of Sichuan University | Chengdu | 610041 | China |
| Ruijin Hospital Shanghai Jiaotong University | Shanghai | 200025 | China |
| Blood Disease Hospital, Chinese Academy of Medical Science and Peking Union Medical College | Tianjin | 300041 | China |
| Clinique Claude BernardOncologie | Albi | 81000 | France |
| CHU Sud | Amiens | 80054 | France |
| CHRU Hopital du bocage | Angers | 49033 | France |
| CH Argenteuil Victor Dupouy | Argenteuil | 95100 | France |
| Centre Hospitalier de la cote basque | Bayonne | 64109 | France |
| Centre Hospitalier | Blois | 41016 | France |
| Hopital Avicenne | Bobigny | 93009 | France |
| Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest | Bordeaux | 33076 | France |
| Polyclinique Bordeaux Nord Aquitaine | Bordeaux | 33300 | France |
| Hopital de Fleyriat | Bourg-en-Bresse | 01012 | France |
| Hopital Augustin Morvan | Brest | 29609 | France |
| CHU | Caen | 14033 | France |
| Centre Francois Baclesse | Caen | 14076 | France |
| CH | Cannes | 06401 | France |
| CH Rene Dubois | Cergy-Pontoise | 95303 | France |
| Centre Hospitalier William Morey | Chalon/Saone Cedex | 71321 | France |
| Hopital Antoine Beclere | Clamart | 92141 | France |
| Hopital dinstruction des armees Percy | Clamart | 92141 | France |
| Chu Estaing | Clermont-Ferrand | 63000 | France |
| CH Louis Pasteur | Colmar | 68024 | France |
| Hopital Henri Mondor | Créteil | 94010 | France |
| CHRU Hopital du bocage | Dijon | 21034 | France |
| Centre Hospitalier General | Dunkirk | 59385 | France |
| Institut Prive de Cancerologie | Grenoble | 38034 | France |
| CHRU | Grenoble | 38043 | France |
| Centre Hospitalier Departemental | La Roche-sur-Yon | 85925 | France |
| CH | Le Chesnay | 78157 | France |
| Hopital J MonodRhumato Nord | Le Havre | 76000 | France |
| Kremlin Bicetre | Le Kremlin-Bicêtre | 942975 | France |
| Centre Jean Bernard | Le Mans | 72000 | France |
| Centre Hospitalier | Le Mans | 72037 | France |
| GH de Institut Catholique St Vincent | Lille | 59000 | France |
| CHRU-Hopital Claude Huriez | Lille | 59037 | France |
| CH - Hôpital Dupuytren | Limoges | 87042 | France |
| Centre Leon Berard | Lyon | 69008 | France |
| CHU Hopital Edouard Herriot | Lyon | 69437 | France |
| Centre Hospitalier de Valence | Lyon | 69495 | France |
| Institut Paoli-Calmettes | Marseille | 13009 | France |
| Hopital de Mercy | Metz | 57085 | France |
| Clinique Pont de chaume Oncologie et Radiotherapie | Montauban | 82017 | France |
| CHU Montpellier - Hôpital Lapeyronie | Montpellier | 34295 | France |
| Hopital Emile Muller | Mulhouse | 68000 | France |
| CHRU - Hotel Dieu | Nantes | 44035 | France |
| Centre Antoine Lacassagne Oncologie medicale et Hematologie | Nice | 06050 | France |
| Hopital de lArchet 1 | Nice | 06202 | France |
| CH La Source | Orléans | 45000 | France |
| Hopital Saint Louis | Paris | 75010 | France |
| Hopital Necker | Paris | 75015 | France |
| CHU Hôpital St-Antoine | Paris | 75571 | France |
| Hopital Cochin | Paris | 75679 | France |
| CHRU - Hopital du Haut Leveque | Pessac | 33604 | France |
| CU CHU Clemenceau | Poitiers | 86021 | France |
| Hopital R. Debre | Reims | 51032 | France |
| CHU Reims - Hôpital Maison Blanche | Reims | 51100 | France |
| CHRU Hôpital de Pontchaillou | Rennes | 35033 | France |
| CHRU Hopital sud Medecine Interne | Rennes | 35056 | France |
| CHG Rodez | Rodez | 12027 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Centre Hospitalier Yves Le Foll | Saint-Brieuc | 22027 | France |
| Centre Rene Huguenin | Saint-Cloud | 92210 | France |
| Institut de Cancerologie de Loire | Saint-Priest-en-Jarez | 42270 | France |
| CHRU Hôpital de Hautepierre | Strasbourg | 67098 | France |
| CHRU Hopital Purpan | Toulouse | TSA 40031-31059 | France |
| CHRU Hopital Bretonneau | Tours | 37044 | France |
| CHRU Hopital Trousseau | Tours | 37044 | France |
| CHRU Hôpitaux de Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| CH P. Chubert | Vannes | 56017 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Medizinische Kinik und Poliklinik I | Dresden | D-01307 | Germany |
| Universitaetsklinikum Dusseldorf Klinik fuer Haematologie | Düsseldorf | 40225 | Germany |
| Universitatsklinikum Essen- | Essen | 45122 | Germany |
| Staedtische Kliniken Frankfurt am Main Hochst | Frankfurt am Main | 65929 | Germany |
| Universitatsklinikum Giessen | Giessen | 35385 | Germany |
| Ernst-Moritz-Arndt-Universität Greifswald | Greifswald | 17487 | Germany |
| Askepios Klinik St. Georg | Hamburg | 20099 | Germany |
| Universitatsklinikum Jena | Jena | 07740 | Germany |
| Medizinische Klinik und Poliklinik II | Leipzig | 04103 | Germany |
| Universitatsklinikum schleswig-Holstein | Lübeck | 23538 | Germany |
| Klinikum der Johann-Wolfgang-Goethe-Universtat | München | 81377 | Germany |
| Medizinische Klinik III Klinikum der Universität München-Großhadern | München | 81377 | Germany |
| Poliklinik A | Münster | 48129 | Germany |
| Medizinische Fakultat der Universitat Rostock | Rostock | 18057 | Germany |
| Zentrum F. Innere Medizin II Robert- Bosch-Krankenhaus GmBH | Stuttgart | D -70376 | Germany |
| Medizinische Klinik - Abteilung II | Tübingen | 72076 | Germany |
| Klinik fur Innere Medizin III | Ulm | 89081 | Germany |
| Alexandra Hospital, University of Athens | Athens | 11528 | Greece |
| Attiko Hospital of Athens | Athens | 124 | Greece |
| Evangelismos Hospital of Athens | Athens | Greece |
| University of Athens | Athens | Greece |
| Metaxa Hospital Peiraias | Piraeus | 18537 | Greece |
| Theagenio Anticancer Hospital of Thessaloniki | Thessaloniki | 540 07 | Greece |
| Adelaide and Meath Hospital | Dublin | 24 | Ireland |
| Mater Misercordiae Hospital | Dublin | 7 | Ireland |
| University Hospital Galway | Galway | ST46QG | Ireland |
| Policlinico S. Orsola | Bologna | 40138 | Italy |
| Oncologia Medica, Università della Magna Grecia | Catanzaro | 88100 | Italy |
| Clinica Ematologica, A.O.U. San Martino di Genova | Genova | 16132 | Italy |
| Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce | Lecce | 73100 | Italy |
| Unità Operativa di Oncoematologia, Ospedale di Matera | Matera | 75100 | Italy |
| U.O. di Ematologia e Trapianto di Midollo Osseo | Milan | 20132 | Italy |
| Istituto Europeo di Oncologia - IEO | Milan | 20141 | Italy |
| Presidio Ospedaliero A. Perrino | Milan | 20141 | Italy |
| Policlinico di Modena | Modena | 41100 | Italy |
| Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale | Naples | 80131 | Italy |
| Casa di Cura La Maddalena, Divisione di Ematologia | Palermo | 90146 | Italy |
| Policlinico San Matteo Universita Di Pavia | Pavia | 27100 | Italy |
| Ospedale Civile | Piacenza | 29100 | Italy |
| A.O. Universitaria Ospedale S.Chiara Dip.Oncologia, Div. Ematologia | Pisa | 56126 | Italy |
| Arcispedale Santa Maria Nuova | Reggio Emilia | 42100 | Italy |
| Istituto Nazionale Tumori Regina Elena, Struttura Complessa Ematologia ed Unita di Cellule Staminali | Roma | 00144 | Italy |
| Azienda Policlinico Umberto I, Universita La Sapienzadi Roma | Rome | 00161 | Italy |
| Ospedale Molinette | Torino | 10126 | Italy |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| Christchurch Hospital | Christchurch | 8011 | New Zealand |
| Wellington Hospital | Newtown | 6021 | New Zealand |
| Hospital de Sao Marcos | Braga | Portugal |
| Hospitais da Universidade de Coimbra | Coimbra | 3000-075 | Portugal |
| Instituto Portugues de Oncologia de Lisboa | Lisbon | 1099-023 | Portugal |
| Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| Instituto Português de Oncologia Porto | Porto | 4200-072 | Portugal |
| Hospital de Santo Antonio- Porto | Porto | Portugal |
| Hallym University Sacred Heart Hospital | Anyang | 431-070 | South Korea |
| Inje University Busan Paik Hospital | Busan | 614-735 | South Korea |
| Daegu Catholic University Medical Center 3056-6 | Daegu | 705-718 | South Korea |
| Chungnam National University Hospital | Daejeon | 301-721 | South Korea |
| National Cancer Center | Gyeonggi-do | 410-769 | South Korea |
| Hwasun Chonnam National University Hospital | Hwasun-goon | 519-803 | South Korea |
| Gachon University Gil Hospital | Incheon | 405-760 | South Korea |
| Chonbuk National University Hospital 42 | Jeonju | 561-712 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | 463-707 | South Korea |
| Severance Hospital | Seongsanno | 120-752 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| The Catholic University of Korea Seoul - Saint Mary's Hospital | Seoul | 137-701 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 158-710 | South Korea |
| Hospital Universitari Germans Trias i Pujol | Badalona (Barcelona) | 8916 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Instituto Catalan de Oncologia-Hospital Duran | Barcelona | 08907 | Spain |
| Hospital Reina Sofia | Córdoba | 14004 | Spain |
| Hospital de Donosti | Donostia / San Sebastian | 20014 | Spain |
| Hospital Univ. Josep Trueta | Girona | 17007 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Clinico Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital General Universitario Morales Messeguer | Murcia | 30008 | Spain |
| Hospital Son Llatzer | Palma de Mallorca | 7198 | Spain |
| Clinica Universitaria de Navarra, | Pamplona | 31008 | Spain |
| Hospital Sant Pau | Reus | 43201 | Spain |
| Hospital Universtario Marques de Valdecilla | Santander | 39008 | Spain |
| Hospital Clinico Santiago de Compostela | Santiago de Compostela | 15706 | Spain |
| Hosptial La Fe | Valencia | 46009 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Clinico Universitario Lozano Blesa | Zaragoza | 50009 | Spain |
| Hospital Miguel Servet | Zaragoza | 50009 | Spain |
| Linkoping University Hospital | Linköping | SE 581 85 | Sweden |
| Karolinska University HospitalSolna | Stockholm | SE 17176 | Sweden |
| St. Görans Hospital | Stockholm | SE- 11281 | Sweden |
| Karolinska University Hospital Huddinge | Stockholm | SE-14186 | Sweden |
| Abteilung Onkologie Haematologie des Kantonsspitals Aarau | Aarau | 5001 | Switzerland |
| UniversitatsSpital Basel | Basel | 4031 | Switzerland |
| Inselsspital Bern | Bern | 3010 | Switzerland |
| Kantonsspital Graubunden | Chur | 7000 | Switzerland |
| Centre Hospitalier Universitaire Vaudois CHUV | Lausanne | 1011 | Switzerland |
| Kantonsspital Munsterlingen | Münsterlingen | 8596 | Switzerland |
| Kantonsspital Winterthur | Winterthur | 8400 | Switzerland |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Veteran General Hospital - Taipei | Taipei | 11217 | Taiwan |
| National Taiwan University Hospital | Tapei | 10002 | Taiwan |
| Gwynedd Hospital | Bangor | LL57 2PW | United Kingdom |
| Royal United Hospital | Bath | BA1 3NG | United Kingdom |
| Belfast City Hospital Haematology Department | Belfast Northern Ireland | BT9 7AB | United Kingdom |
| Birminghman QE | Birmingham West Midlands | B15 2TH | United Kingdom |
| Royal Bournemouth Hosp | Bournemouth Dorset | BH7 7DW | United Kingdom |
| Bristol Haematology and Oncology Centre | Bristol | BS2 8ED | United Kingdom |
| Addenbrooke's Hospital | Cambridge | CB2 2QQ | United Kingdom |
| University Hospital of Wales - Cardiff | Cardiff | CF14 4XW | United Kingdom |
| The Beatson West of Scotland Centre | Glasgow | G12 0YN | United Kingdom |
| Dept of Haematology St Bartholomews Hospital | London | EC1A 7BE | United Kingdom |
| Guy's and St Thomas' Hospital - London | London | SE1 9RT | United Kingdom |
| Royal Free Hospital | London | W12 0HS | United Kingdom |
| Churchhill Hospital | Oxford | OX3 7LI | United Kingdom |
| Derriford Hospital | Plymouth Crownhill Devon | PL6 8DH | United Kingdom |
| Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust | Sheffield | S10 2JF | United Kingdom |
| Pinderfields General Hospital | West Yorkshire | WF1 4DG | United Kingdom |
| New Cross Hospital- Wolverhampton | Wolverhampton | WV10 OPQ | United Kingdom |
| Background |
| Hulin C, Belch A, Shustik C, Petrucci MT, Duhrsen U, Lu J, Song K, Rodon P, Pegourie B, Garderet L, Hunter H, Azais I, Eek R, Gisslinger H, Macro M, Dakhil S, Goncalves C, LeBlanc R, Romeril K, Royer B, Doyen C, Leleu X, Offner F, Leupin N, Houck V, Chen G, Ervin-Haynes A, Dimopoulos MA, Facon T. Updated Outcomes and Impact of Age With Lenalidomide and Low-Dose Dexamethasone or Melphalan, Prednisone, and Thalidomide in the Randomized, Phase III FIRST Trial. J Clin Oncol. 2016 Oct 20;34(30):3609-3617. doi: 10.1200/JCO.2016.66.7295. |
| 25769541 | Background | Delforge M, Minuk L, Eisenmann JC, Arnulf B, Canepa L, Fragasso A, Leyvraz S, Langer C, Ezaydi Y, Vogl DT, Giraldo-Castellano P, Yoon SS, Zarnitsky C, Escoffre-Barbe M, Lemieux B, Song K, Bahlis NJ, Guo S, Monzini MS, Ervin-Haynes A, Houck V, Facon T. Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide. Haematologica. 2015 Jun;100(6):826-33. doi: 10.3324/haematol.2014.120121. Epub 2015 Mar 13. |
| 25184863 | Background | Benboubker L, Dimopoulos MA, Dispenzieri A, Catalano J, Belch AR, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis N, Banos A, Tiab M, Delforge M, Cavenagh J, Geraldes C, Lee JJ, Chen C, Oriol A, de la Rubia J, Qiu L, White DJ, Binder D, Anderson K, Fermand JP, Moreau P, Attal M, Knight R, Chen G, Van Oostendorp J, Jacques C, Ervin-Haynes A, Avet-Loiseau H, Hulin C, Facon T; FIRST Trial Team. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. N Engl J Med. 2014 Sep 4;371(10):906-17. doi: 10.1056/NEJMoa1402551. |
| 28641472 | Background | Vogl DT, Delforge M, Song K, Guo S, Gibson CJ, Ervin-Haynes A, Facon T. Long-term health-related quality of life in transplant-ineligible patients with newly diagnosed multiple myeloma receiving lenalidomide and dexamethasone. Leuk Lymphoma. 2018 Feb;59(2):398-405. doi: 10.1080/10428194.2017.1334125. Epub 2017 Jun 22. |
| 29784907 | Background | Dumontet C, Hulin C, Dimopoulos MA, Belch A, Dispenzieri A, Ludwig H, Rodon P, Van Droogenbroeck J, Qiu L, Cavo M, Van de Velde A, Lahuerta JJ, Allangba O, Lee JH, Boyle E, Perrot A, Moreau P, Manier S, Attal M, Roussel M, Mohty M, Mary JY, Civet A, Costa B, Tinel A, Gaston-Mathe Y, Facon T. A predictive model for risk of early grade >/= 3 infection in patients with multiple myeloma not eligible for transplant: analysis of the FIRST trial. Leukemia. 2018 Jun;32(6):1404-1413. doi: 10.1038/s41375-018-0133-x. Epub 2018 Apr 26. |
| 29980678 | Background | Ailawadhi S, Jacobus S, Sexton R, Stewart AK, Dispenzieri A, Hussein MA, Zonder JA, Crowley J, Hoering A, Barlogie B, Orlowski RZ, Rajkumar SV. Disease and outcome disparities in multiple myeloma: exploring the role of race/ethnicity in the Cooperative Group clinical trials. Blood Cancer J. 2018 Jul 6;8(7):67. doi: 10.1038/s41408-018-0102-7. |
| 30244101 | Background | Jain T, Sonbol MB, Firwana B, Kolla KR, Almader-Douglas D, Palmer J, Fonseca R. High-Dose Chemotherapy with Early Autologous Stem Cell Transplantation Compared to Standard Dose Chemotherapy or Delayed Transplantation in Patients with Newly Diagnosed Multiple Myeloma: A Systematic Review and Meta-Analysis. Biol Blood Marrow Transplant. 2019 Feb;25(2):239-247. doi: 10.1016/j.bbmt.2018.09.021. Epub 2018 Sep 20. |
| 29150421 | Background | Facon T, Dimopoulos MA, Dispenzieri A, Catalano JV, Belch A, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis NJ, Banos A, Tiab M, Delforge M, Cavenagh JD, Geraldes C, Lee JJ, Chen C, Oriol A, De La Rubia J, White D, Binder D, Lu J, Anderson KC, Moreau P, Attal M, Perrot A, Arnulf B, Qiu L, Roussel M, Boyle E, Manier S, Mohty M, Avet-Loiseau H, Leleu X, Ervin-Haynes A, Chen G, Houck V, Benboubker L, Hulin C. Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma. Blood. 2018 Jan 18;131(3):301-310. doi: 10.1182/blood-2017-07-795047. Epub 2017 Nov 17. |
| 30773308 | Background | Ailawadhi S, DerSarkissian M, Duh MS, Lafeuille MH, Posner G, Ralston S, Zagadailov E, Ba-Mancini A, Rifkin R. Cost Offsets in the Treatment Journeys of Patients With Relapsed/Refractory Multiple Myeloma. Clin Ther. 2019 Mar;41(3):477-493.e7. doi: 10.1016/j.clinthera.2019.01.009. Epub 2019 Feb 14. |
| 30859608 | Background | Pegourie B, Karlin L, Benboubker L, Orsini-Piocelle F, Tiab M, Auger-Quittet S, Rodon P, Royer B, Leleu X, Bareau B, Cliquennois M, Fuzibet JG, Voog E, Belhadj-Merzoug K, Decaux O, Rey P, Slama B, Leyronnas C, Zarnitsky C, Boyle E, Bosson JL, Pernod G; IFM Group. Apixaban for the prevention of thromboembolism in immunomodulatory-treated myeloma patients: Myelaxat, a phase 2 pilot study. Am J Hematol. 2019 Jun;94(6):635-640. doi: 10.1002/ajh.25459. Epub 2019 Apr 1. |
| 28373701 | Result | Bahlis NJ, Corso A, Mugge LO, Shen ZX, Desjardins P, Stoppa AM, Decaux O, de Revel T, Granell M, Marit G, Nahi H, Demuynck H, Huang SY, Basu S, Guthrie TH, Ervin-Haynes A, Marek J, Chen G, Facon T. Benefit of continuous treatment for responders with newly diagnosed multiple myeloma in the randomized FIRST trial. Leukemia. 2017 Nov;31(11):2435-2442. doi: 10.1038/leu.2017.111. Epub 2017 Apr 4. |
| 28106903 | Result | Lu J, Lee JH, Huang SY, Qiu L, Lee JJ, Liu T, Yoon SS, Kim K, Shen ZX, Eom HS, Chen WM, Min CK, Kim HJ, Lee JO, Kwak JY, Yiu W, Chen G, Ervin-Haynes A, Hulin C, Facon T. Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial. Br J Haematol. 2017 Mar;176(5):743-749. doi: 10.1111/bjh.14465. Epub 2017 Jan 20. |
| FG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| FG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
| Safety Population |
|
| Untreated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Progression Free Survival-PFS-Follow-Up |
|
| Long-Term Follow Up Phase |
|
|
Intent to Treat (ITT) population includes all participants who were randomized, independent of whether they received study treatment or not
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lenalidomide and Low-Dose Dexamethasone (Rd) | Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. |
| BG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| BG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| International Staging System (ISS) | International Staging System (ISS) is used as a staging system for multiple myeloma and divides myeloma into 3 stages based only on the serum beta-2 microglobulin and serum albumin levels. Higher stages represent more advanced disease. | Number | Participants |
| |||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Eastern Cooperative Oncology Group (ECOG) Performance Status is used to assess the progress of disease in a patient, how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. | Number | Participants |
| |||||||||||||||
| Creatinine clearance | Number | Participants |
| ||||||||||||||||
| Beta2 Microglobulin | Number | Participants |
| ||||||||||||||||
| Albumin | Number | Participants |
| ||||||||||||||||
| Lactic Dehydrogenase | Number | Participants |
| ||||||||||||||||
| Multiple Myeloma Subtype | Number | Participants |
| ||||||||||||||||
| Cytogenetic Risk | Cytogenetic risk categories are mutually exclusive. Definitions: Adverse risk category: t(4:14), t(14:16), del (13q) or monosomy 13, del (17p), 1q gain; Non-adverse risk categories include favorable hyperdiploidy: t(11:14), gains of 5/9/15; normal: a normal result, gains other than 5/9/15, IgH deletion, and uncertain risk: probes used for analysis cannot place participant in any risk categories. Not evaluable: no specimen received, test failure or insufficient number of cells available for analysis. | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC) | PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's). | The intent to treat (ITT) population included all participants who were randomized, independent of whether they received study treatment or not. | Posted | Median | 95% Confidence Interval | months | From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis | PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's). | The intent to treat population included all participants who were randomized, independent of whether they received study treatment or not. | Posted | Median | 95% Confidence Interval | months | From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS) | Overall survival was defined as the time between randomization and death. Participants, who died, regardless of the cause of death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the participant was known to be alive. | ITT population included all participants who were randomized, independent of whether they received study treatment or not. | Posted | Median | 95% Confidence Interval | months | From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Objective Response Based on IRAC Review | Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined as: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. | ITT population includes all participants who were randomized, independent of whether they received study treatment or not. | Posted | Number | percentage of participants | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis | Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. | ITT population includes all participants who were randomized, independent of whether they received study treatment or not. | Posted | Number | percentage of participants | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC | Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first. | Study participants with at least a PR | Posted | Median | 95% Confidence Interval | months | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis | Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first. | Study participants with at least a PR | Posted | Median | 95% Confidence Interval | months | Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Response Based on the Review by the IRAC | The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria. | Participants who had at least a PR. | Posted | Median | Full Range | months | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Response Based on the Investigator Assessment at the Time of Final Analysis | The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria assessed by the investigator. | Participants who had at least a PR. | Posted | Median | Full Range | months | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan Meier Estimates of Time to Treatment Failure (TTF) | TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by IRAC based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death. | ITT population includes participants who were randomized, independent of whether they received study treatment or not | Posted | Median | 95% Confidence Interval | months | From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 16.1 months. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis | TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by the investigators assessment based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death. | ITT population includes participants who were randomized, independent of whether they received study treatment or not | Posted | Median | 95% Confidence Interval | months | From date of randomization until the data cut-off date of 21 January 2016; median follow up for all participants was 16.1 months. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT) | Time to second-line anti-myeloma therapy was defined as time from randomization to the start of another non-protocol anti-myeloma therapy. | ITT population includes all participants who were randomized, independent of whether they received study treatment or not | Posted | Median | 95% Confidence Interval | months | From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 23.0 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis | Time to second-line anti-myeloma therapy is defined as time from randomization to the start of another non-protocol anti-myeloma therapy. Those who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy. | ITT population includes all participants who were randomized, independent of whether they received study treatment or not. | Posted | Median | Full Range | months | From date of randomization until the data cut-off of date 21 January 2016; median follow-up for all participants was 23.0 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis | Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. | ITT population; Participants with second line AMT. | Posted | Number | percentage of participants | Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review. | Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. | ITT population with Cytogenetic risk of Adverse Risk | Posted | Number | Percentage of participants | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review | Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. | ITT population with a Cytogenetic Risk of Favorable Hyperploidy | Posted | Number | percentage of participants | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review | Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. | ITT population with a cytogenetic risk of normal | Posted | Number | percentage of particpants | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review | Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. | ITT population with a Cytogenetic Risk of Uncertain Risk | Posted | Number | percentage of participants | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement. | Intent to Treat (ITT) population with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Intent to Treat (ITT) population with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Intent to Treat (ITT) population with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Intent to Treat (ITT) population with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Intent to Treat (ITT) population with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1, (Baseline) then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Intent to Treat (ITT) population with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. | Intent to Treat (ITT) population with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EORTC QLQ-C30 Pain Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. | Intent to Treat (ITT) population with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea/Vomiting Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. | Intent to Treat (ITT) population with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. | ITT population includes all participants with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. | Intent to Treat (ITT) population with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Scale is scored between 0 and 100, with a high score indicating a higher level of appetite loss. Negative change from Baseline values indicate improvement in appetite and positive values indicate worsening of appetite. | ITT population with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EORTC QLQ-C30 Constipation Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Scale is scored between 0 and 100, with a high score indicating a higher level of constipation. Negative change from Baseline values indicate improvement in constipation and positive values indicate worsening of constipation. | ITT population with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Diarrhea Scale is scored between 0 and 100, with a high score indicating a higher level of diarrhea. Negative change from Baseline values indicate improvement in diarrhea and positive values indicate worsening of diarrhea. | ITT population with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Difficulties Scale is scored between 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicate improvement in financial difficulties and positive values indicate worsening of financial difficulties. | ITT population with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score indicates more severe disease symptom(s). | ITT population with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment. | ITT population with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the future perspective scale, a higher score indicates a better perspective of the future. | ITT population with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the body image scale, a higher score indicates a better body image. | ITT population with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | EQ-5D is a self-administered questionnaire that assesses health-related quality of life. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where higher EQ-5D scores represent better health status. A positive change from baseline score indicates improvement in health status and better health state. | ITT population with available data. | Posted | Mean | Standard Deviation | units on a scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year | HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of inpatient hospitalizations per patient year was calculated as the total number of hospitalizations divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient. | Healthcare Resource Utilization not analyzed. | Posted | Day 1 (randomization) up to last visit completed 25 July 2016 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | A TEAE is any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. | Safety population included all participants who received at least one dose treatment dose of treatment in any arm | Posted | Number | Participants | From first dose of study drug through 28 days following the discontinuation visit from active treatment phase; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | Renal function was assessed for participants from baseline to the most extreme value in creatinine clearance calculated using the Cockcroft-Gault estimation. | Safety Population with baseline and postbaseline CrCl data. | Posted | Number | participants | Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Neutrophil counts was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. | Safety Population; includes participants with baseline and postbaseline absolute neutrophil laboratory test grade information | Posted | Number | participants | Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Hemoglobin was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. | Safety Population; Includes participants with baseline and postbaseline hemoglobin laboratory test grade information | Posted | Number | participants | Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Improvement in platelets was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. | Safety population; Includes participants with baseline and postbaseline platelet laboratory test grade information | Posted | Number | participants | Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Improvement of Infection Rate by Observing the Historical Data Compared to the Clinical Data Base | Improvement of infection rate by observing historical data compared to the data within clinical database as not analyzed. | Posted | From randomization to 24 May 2013 |
|
From the first dose of treatment to at least 28 days after discontinuation of active treatment for those not continuing in the PFS phase; median duration of treatment was 80.2 weeks in the Rd arm, 72.0 weeks in the Rd18 arm and 67.1 weeks in the MPT arm.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lenalidomide and Low-Dose Dexamethasone (Rd) | Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. | 378 | 532 | 523 | 532 | ||
| EG001 | Lenalidomide and Dexamethasone (Rd18) | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. | 308 | 540 | 532 | 540 | ||
| EG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. | 270 | 541 | 532 | 541 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ANAEMIA HAEMOLYTIC AUTOIMMUNE | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DISSEMINATED INTRAVASCULAR COAGULATION | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| FEBRILE BONE MARROW APLASIA | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HAEMOLYSIS | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPERVISCOSITY SYNDROME | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPOCOAGULABLE STATE | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| IDIOPATHIC THROMBOCYTOPENIC PURPURA | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| LYMPHADENITIS | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ACUTE CORONARY SYNDROME | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ARRHYTHMIA | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ARRHYTHMIA SUPRAVENTRICULAR | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ARTERIOSCLEROSIS CORONARY ARTERY | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ATRIAL THROMBOSIS | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK COMPLETE | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| BRADYARRHYTHMIA | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CARDIAC AMYLOIDOSIS | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CARDIAC FLUTTER | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CARDIOGENIC SHOCK | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CARDIOMYOPATHY | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CARDIOPULMONARY FAILURE | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CONGESTIVE CARDIOMYOPATHY | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| COR PULMONALE | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CORONARY ARTERY INSUFFICIENCY | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CORONARY ARTERY STENOSIS | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DIASTOLIC DYSFUNCTION | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPERTENSIVE HEART DISEASE | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| LEFT VENTRICULAR DYSFUNCTION | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| LEFT VENTRICULAR FAILURE | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MITRAL VALVE INCOMPETENCE | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| NODAL ARRHYTHMIA | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PERICARDITIS | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RIGHT VENTRICULAR FAILURE | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SICK SINUS SYNDROME | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SINOATRIAL BLOCK | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SINUS ARREST | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SINUS BRADYCARDIA | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| TACHYARRHYTHMIA | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| VENTRICULAR FLUTTER | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| VENTRICULAR TACHYCARDIA | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| LEFT VENTRICLE OUTFLOW TRACT OBSTRUCTION | Congenital, familial and genetic disorders | MEDDRA15.1 | Systematic Assessment |
| |
| THALASSAEMIA BETA | Congenital, familial and genetic disorders | MEDDRA15.1 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPERTHYROIDISM | Endocrine disorders | MEDDRA15.1 | Systematic Assessment |
| |
| THYROID CYST | Endocrine disorders | MEDDRA15.1 | Systematic Assessment |
| |
| BLINDNESS UNILATERAL | Eye disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CATARACT | Eye disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CHOROIDAL DETACHMENT | Eye disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CONJUNCTIVAL OEDEMA | Eye disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DIABETIC RETINOPATHY | Eye disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DIPLOPIA | Eye disorders | MEDDRA15.1 | Systematic Assessment |
| |
| GLAUCOMA | Eye disorders | MEDDRA15.1 | Systematic Assessment |
| |
| OCULAR HYPERTENSION | Eye disorders | MEDDRA15.1 | Systematic Assessment |
| |
| UVEITIS | Eye disorders | MEDDRA15.1 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ABDOMINAL WALL HAEMATOMA | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| COLITIS ISCHAEMIC | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| COLONIC POLYP | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DIVERTICULAR PERFORATION | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DIVERTICULUM | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ENTERITIS | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ENTEROCOLITIS | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ENTEROCUTANEOUS FISTULA | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ENTEROVESICAL FISTULA | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| FAECALOMA | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| GASTRIC DISORDER | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| GASTRIC ULCER HAEMORRHAGE | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| GASTROINTESTINAL MOTILITY DISORDER | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| GASTROINTESTINAL NECROSIS | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| GASTROINTESTINAL STENOSIS | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| GINGIVAL BLEEDING | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HAEMATEMESIS | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HAEMORRHAGIC EROSIVE GASTRITIS | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HIATUS HERNIA | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ILEUS PARALYTIC | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| INGUINAL HERNIA STRANGULATED | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| INGUINAL HERNIA, OBSTRUCTIVE | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| INTESTINAL ISCHAEMIA | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| INTESTINAL PERFORATION | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| NECROTISING COLITIS | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| OBSTRUCTION GASTRIC | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| OESOPHAGEAL STENOSIS | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| OESOPHAGITIS | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ORAL DISORDER | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PEPTIC ULCER HAEMORRHAGE | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RECTAL PERFORATION | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| REFLUX GASTRITIS | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SIGMOIDITIS | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SUBILEUS | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| TONGUE HAEMATOMA | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| UMBILICAL HERNIA, OBSTRUCTIVE | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CHILLS | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DEATH | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| GENERALISED OEDEMA | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPERPYREXIA | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPERTHERMIA | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPOTHERMIA | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| INFLAMMATION | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| INJECTION SITE HAEMORRHAGE | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MALAISE | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MULTI-ORGAN FAILURE | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PAIN | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PERFORMANCE STATUS DECREASED | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SPINAL PAIN | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SUDDEN DEATH | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SYSTEMIC INFLAMMATORY RESPONSE SYNDROME | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ULCER HAEMORRHAGE | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| BILE DUCT OBSTRUCTION | Hepatobiliary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| BILE DUCT STONE | Hepatobiliary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CHOLANGITIS | Hepatobiliary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DRUG-INDUCED LIVER INJURY | Hepatobiliary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HEPATIC FAILURE | Hepatobiliary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HEPATITIS ACUTE | Hepatobiliary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPERTRANSAMINASAEMIA | Hepatobiliary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| LIVER DISORDER | Hepatobiliary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| AMYLOIDOSIS | Immune system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ANAPHYLACTIC SHOCK | Immune system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DRUG HYPERSENSITIVITY | Immune system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ABDOMINAL ABSCESS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| ABDOMINAL WALL ABSCESS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| ABSCESS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| ABSCESS LIMB | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| ANORECTAL INFECTION BACTERIAL | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| ARTHRITIS BACTERIAL | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| ARTHRITIS INFECTIVE | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| ATYPICAL PNEUMONIA | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| BACTERIAL SEPSIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| BRONCHOPNEUMONIA | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| BRONCHOPULMONARY ASPERGILLOSIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| BURSITIS INFECTIVE STAPHYLOCOCCAL | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| CAMPYLOBACTER INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| CHOLECYSTITIS INFECTIVE | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| CLOSTRIDIAL INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| DIARRHOEA INFECTIOUS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| DOUGLAS' ABSCESS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| EMBOLIC PNEUMONIA | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| ENDOCARDITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| ENDOCARDITIS BACTERIAL | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| ENDOCARDITIS STAPHYLOCOCCAL | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| ENDOPHTHALMITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| ENTEROCOCCAL SEPSIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| ENTEROCOLITIS INFECTIOUS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| EPIGLOTTITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| ESCHERICHIA SEPSIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| FUNGAL INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| FURUNCLE | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| GASTROENTERITIS SALMONELLA | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| GASTROINTESTINAL INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| HEPATITIS B | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| INFECTIVE TENOSYNOVITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| INTERVERTEBRAL DISCITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| KLEBSIELLA BACTERAEMIA | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| KLEBSIELLA INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| KLEBSIELLA SEPSIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| LOBAR PNEUMONIA | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| LOCALISED INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| LUNG INFECTION PSEUDOMONAL | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| MENINGITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| MENINGITIS CRYPTOCOCCAL | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| MENINGOCOCCAL SEPSIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| NEUTROPENIC SEPSIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| OESOPHAGEAL CANDIDIASIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| ORCHITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| OROPHARYNGEAL CANDIDIASIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PERIODONTITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PERIORBITAL ABSCESS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PERIORBITAL CELLULITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PERITONITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PNEUMOCOCCAL BACTERAEMIA | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PNEUMOCOCCAL SEPSIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PNEUMOCYSTIS JIROVECI PNEUMONIA | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PNEUMONIA BACTERIAL | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PNEUMONIA ESCHERICHIA | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PNEUMONIA KLEBSIELLA | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PNEUMONIA LEGIONELLA | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PNEUMONIA PNEUMOCOCCAL | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PNEUMONIA STAPHYLOCOCCAL | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PNEUMONIA STREPTOCOCCAL | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PNEUMONIA VIRAL | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| POST PROCEDURAL SEPSIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| POSTOPERATIVE ABSCESS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PROSTATIC ABSCESS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PSEUDOMEMBRANOUS COLITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PSEUDOMONAL SEPSIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PULMONARY TUBERCULOSIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PYELONEPHRITIS ACUTE | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| RESPIRATORY SYNCYTIAL VIRUS INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| SOFT TISSUE INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL BACTERAEMIA | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL IMPETIGO | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| STRONGYLOIDIASIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| SUBCUTANEOUS ABSCESS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| TOOTH ABSCESS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| TRACHEOBRONCHITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| TUBERCULOSIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| TUBERCULOUS PLEURISY | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION BACTERIAL | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| WHIPPLE'S DISEASE | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| ACETABULUM FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| ALCOHOL POISONING | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| BLADDER INJURY | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| CERVICAL VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| CRANIOCEREBRAL INJURY | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| FACE INJURY | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| FOOT FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| FRACTURED SACRUM | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| HEAD INJURY | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| HEART INJURY | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| INCISIONAL HERNIA | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| JAW FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| LACERATION | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| MEDICATION ERROR | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| MENISCUS LESION | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| POST PROCEDURAL HAEMATOMA | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| PUBIS FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| RESPIRATORY FUME INHALATION DISORDER | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| SPINAL FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| STERNAL FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| SUBDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| TENDON RUPTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| THORACIC VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| TRANSFUSION-RELATED ACUTE LUNG INJURY | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| TRAUMATIC FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| ULNA FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| WRIST FRACTURE | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| BIOPSY BONE MARROW ABNORMAL | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS WORSENED | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| EJECTION FRACTION DECREASED | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| HAEMOGLOBIN ABNORMAL | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| HEART RATE INCREASED | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| LIVER FUNCTION TEST ABNORMAL | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| PROTEIN URINE PRESENT | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| PROTHROMBIN TIME RATIO INCREASED | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| TROPONIN INCREASED | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| TROPONIN T INCREASED | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| CACHEXIA | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| FAILURE TO THRIVE | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| FOOD INTOLERANCE | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| GOUT | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIC HYPEROSMOLAR NONKETOTIC SYNDROME | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPERURICAEMIA | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPOPROTEINAEMIA | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| IRON DEFICIENCY | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MALNUTRITION | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MARASMUS | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| METABOLIC ALKALOSIS | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SHOCK HYPOGLYCAEMIC | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| TETANY | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| BONE LESION | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CHONDROCALCINOSIS PYROPHOSPHATE | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DUPUYTREN'S CONTRACTURE | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| FIBROMYALGIA | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| GOUTY ARTHRITIS | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| GOUTY TOPHUS | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC DEGENERATION | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC DISORDER | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| LUMBAR SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MONARTHRITIS | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MUSCLE HAEMORRHAGE | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MYOPATHY | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| OSTEOCHONDROSIS | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| OSTEOLYSIS | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| OSTEONECROSIS OF JAW | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| OSTEOPOROTIC FRACTURE | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| POLYARTHRITIS | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SOFT TISSUE MASS | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SPINAL COLUMN STENOSIS | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SPINAL DISORDER | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SYNOVIAL CYST | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| VERTEBRAL WEDGING | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ACUTE LYMPHOCYTIC LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| BLADDER TRANSITIONAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| BOWEN'S DISEASE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| BREAST CANCER IN SITU | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| CARCINOID TUMOUR OF THE APPENDIX | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| CARDIAC MYXOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| COLON ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| COLON CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| COLON CANCER STAGE IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| ENDOMETRIAL CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| ENDOMETRIAL CANCER STAGE III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| GASTRIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| GASTROINTESTINAL NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| HEPATIC NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| LENTIGO MALIGNA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| LEUKAEMIA PLASMACYTIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA STAGE IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| LUNG CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| LUNG NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| LUNG SQUAMOUS CELL CARCINOMA STAGE I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| MENINGIOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| METASTASES TO CENTRAL NERVOUS SYSTEM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| METASTATIC MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| MULTIPLE MYELOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| MYELODYSPLASTIC SYNDROME | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| NEOPLASM SWELLING | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| OESOPHAGEAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| ORAL NEOPLASM BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| PLASMACYTOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| PROSTATE CANCER RECURRENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| PROSTATIC ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| RECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| SALIVARY GLAND CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| SMALL INTESTINE CARCINOMA METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| TRANSITIONAL CELL CANCER OF THE RENAL PELVIS AND URETER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| TUMOUR FLARE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA15.1 | Systematic Assessment |
| |
| ALTERED STATE OF CONSCIOUSNESS | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| APHASIA | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| BRAIN STEM INFARCTION | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CAROTID ARTERY STENOSIS | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CAUDA EQUINA SYNDROME | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| COMA | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| COORDINATION ABNORMAL | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DEMENTIA | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DYSTONIA | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| EPIDURITIS | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| EPILEPSY | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| GRAND MAL CONVULSION | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| GUILLAIN-BARRE SYNDROME | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HAEMORRHAGIC STROKE | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HEMIPARESIS | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ISCHAEMIC CEREBRAL INFARCTION | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| LACUNAR INFARCTION | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MOTOR NEURONE DISEASE | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PARALYSIS | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PARAPARESIS | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PARAPLEGIA | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PARKINSON'S DISEASE | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PARKINSONISM | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PERIPHERAL MOTOR NEUROPATHY | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PERIPHERAL SENSORIMOTOR NEUROPATHY | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| POLYNEUROPATHY | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| POST HERPETIC NEURALGIA | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PYRAMIDAL TRACT SYNDROME | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RADICULITIS | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| REPETITIVE SPEECH | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SPEECH DISORDER | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SPINAL CORD COMPRESSION | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| TRANSIENT GLOBAL AMNESIA | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| TRIGEMINAL NEURALGIA | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| VASCULAR ENCEPHALOPATHY | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| AGITATED DEPRESSION | Psychiatric disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MEDDRA15.1 | Systematic Assessment |
| |
| COMPLETED SUICIDE | Psychiatric disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DEPRESSED MOOD | Psychiatric disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DISORIENTATION | Psychiatric disorders | MEDDRA15.1 | Systematic Assessment |
| |
| EUPHORIC MOOD | Psychiatric disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HALLUCINATION | Psychiatric disorders | MEDDRA15.1 | Systematic Assessment |
| |
| IMPAIRED SELF-CARE | Psychiatric disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MAJOR DEPRESSION | Psychiatric disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ACUTE PRERENAL FAILURE | Renal and urinary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| AZOTAEMIA | Renal and urinary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| BLADDER PROLAPSE | Renal and urinary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| OLIGURIA | Renal and urinary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PROTEINURIA | Renal and urinary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RENAL ARTERY STENOSIS | Renal and urinary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RENAL COLIC | Renal and urinary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RENAL FAILURE CHRONIC | Renal and urinary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| URINARY BLADDER HAEMORRHAGE | Renal and urinary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MEDDRA15.1 | Systematic Assessment |
| |
| EPIDIDYMITIS | Reproductive system and breast disorders | MEDDRA15.1 | Systematic Assessment |
| |
| GENITAL PROLAPSE | Reproductive system and breast disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PROSTATITIS | Reproductive system and breast disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ACUTE PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| BRONCHIECTASIS | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| BRONCHOPNEUMOPATHY | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| BRONCHOSPASM | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HAEMOTHORAX | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PULMONARY ALVEOLAR HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PULMONARY ARTERIAL HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PULMONARY HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PULMONARY INFARCTION | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PULMONARY THROMBOSIS | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RESPIRATORY ALKALOSIS | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SLEEP APNOEA SYNDROME | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ACTINIC KERATOSIS | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ACUTE FEBRILE NEUTROPHILIC DERMATOSIS | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CUTANEOUS VASCULITIS | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DECUBITUS ULCER | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DERMATITIS ALLERGIC | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DERMATITIS EXFOLIATIVE | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| EXFOLIATIVE RASH | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RASH MACULAR | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RASH PRURITIC | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SKIN ULCER | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| TOXIC EPIDERMAL NECROLYSIS | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| AORTIC ANEURYSM | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| AORTIC ANEURYSM RUPTURE | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| AORTIC DISSECTION | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ARTERIAL HAEMORRHAGE | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPOVOLAEMIC SHOCK | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PERIPHERAL ARTERY ANEURYSM | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PERIPHERAL ARTERY THROMBOSIS | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PHLEBITIS | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SHOCK | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| THROMBOPHLEBITIS | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| THROMBOPHLEBITIS SUPERFICIAL | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| THROMBOSIS | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| VENOUS THROMBOSIS | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MEDDRA15.1 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CATARACT | Eye disorders | MEDDRA15.1 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| OEDEMA | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MEDDRA15.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MEDDRA15.1 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MEDDRA15.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MEDDRA15.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PERIPHERAL MOTOR NEUROPATHY | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MEDDRA15.1 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MEDDRA15.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MEDDRA15.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MEDDRA15.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MEDDRA15.1 | Systematic Assessment |
|
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than one year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to ninety days; Investigator must delete confidential information before submission or defer publication to permit patent applications
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne McClain, Senior Manager, Clinical Trial Disclosure | Celgene Corporation | 888-260-1599 | ClinicalTrialDisclosure@celgene.com |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| D008558 | Melphalan |
| D011241 | Prednisone |
| D013792 | Thalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011244 | Pregnadienediols |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Native Hawaiian or other Pacific Islanders |
|
| White or Caucasian |
|
| Other, Miscellaneous |
|
| Undisclosed |
|
| Not Hispanic or Latino |
|
| Undisclosed |
|
| Stage II |
|
| Stage III |
|
| 1 (restrictive but ambulatory) |
|
| 2 (ambulatory but unable to work) |
|
| 3-4 (limited self-care, completely disabled) |
|
| Missing |
|
| <60 ml/min |
|
| Missing |
|
| <=5.5 mg/L |
|
| Missing |
|
| > 35 g/L |
|
| Missing |
|
| >=200 U/L |
|
| Missing |
|
| Immunoglobulin A and Immunoglobulin G |
|
| Immunoglobulin A and Immunoglobulin M |
|
| Immunoglobulin D |
|
| Immunoglobulin G |
|
| Immunoglobulin M |
|
| Not available (includes light-chain disease) |
|
| Favorable Hyperdiploidy |
|
| Normal |
|
| Uncertain Risk |
|
| Not evaluable |
|
| Missing |
|
| Log Rank |
| 0.00001 |
The p-value is based on the unstratified log-rank test. |
| Hazard Ratio (HR) |
| 0.70 |
| 2-Sided |
| 95 |
| 0.60 |
| 0.82 |
Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups. |
| Superiority or Other (legacy) |
| Log Rank | 0.70349 | The p-value is based on the unstratified log-rank test. | Hazard Ratio (HR) | 1.03 | 2-Sided | 95 | 0.89 | 1.20 | Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups. | Superiority or Other (legacy) |
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
|
| Lenalidomide and Dexamethasone Rd18 |
Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
|
Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
|
| Lenalidomide and Dexamethasone Rd18 |
Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
|
| Lenalidomide and Dexamethasone Rd18 |
Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
|
Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
| OG001 | Lenalidomide and Dexamethasone Rd18 | Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| Lenalidomide and Dexamethasone Rd18 |
Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| Lenalidomide and Dexamethasone Rd18 |
Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| Lenalidomide and Dexamethasone Rd18 |
Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those > 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. |
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|
|
| OG002 | Melphalan + Prednisone + Thalidomide (MPT) | Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. |
|