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The purpose of this study is to evaluate the efficacy and safety of pomalidomide in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pomalidomide plus dexamethasone | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomalidomide | Drug | 4 mg oral pomalidomide once daily Days 1-21 of each 28-day cycle |
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| Measure | Description | Time Frame |
|---|---|---|
| Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria | Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: 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; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required. | From the first dose until the data cut-off date of 03 Sept 2014; Maximum time in follow-up was 36.0 weeks. |
| Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria (Later Cut-off Date) | Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: 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; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required. | From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria | Myeloma response was defined as a best overall response of complete response (CR) or partial response (PR) CR is defined as: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions. |
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Inclusion Criteria:
1. Must be ≥ 20 years of age at the time of signing the informed consent document.
2. The subject must understand and voluntarily sign an informed consent document before any study related assessments/procedures are conducted.
3. Must be able to adhere to the study visit schedule and other protocol requirements.
4. Have a documented diagnosis of multiple myeloma and have relapsed and refractory disease. Subjects must have received at least 2 prior therapies. Subjects must have relapsed after having achieved at least stable disease for at least one cycle of treatment to at least one prior regimen and then developed progressive disease(PD). Subjects must also have documented evidence of progressive disease(PD) during or within 60 days (measured from the end of the last cycle) of completing treatment with the last antimyeloma drug regimen used just prior to study entry (refractory disease).
5. Subjects must have undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of bortezomib (either in separate regimens or within the same regimen).
6. Subjects must have documented diagnosis of multiple myeloma and have measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours).
7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
8.Must agree to comply to pomalidomide Pregnancy Prevention Risk Management Plan.
Exclusion Criteria:
1. Pregnant or breastfeeding females 2. Hypersensitivity to thalidomide, lenalidomide, or dexamethasone 3. ≥ Grade 3 rash during prior thalidomide or lenalidomide therapy 4. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment will not be eligible to participate in this study 5. Any of the following laboratory abnormalities:
Cockcroft-Gault estimation of Creatinine Clearance:
Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L)
Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior Red blood cell transfusion or recombinant human erythropoietin use is permitted)
Serum glutamic oxaloacetic transaminase(SGOT)/aspartate aminitransferase(AST) or serum glutamic pyruvic transaminase(SGPT)/alanine aminotransferase(ALT) > 3.0 x upper limit of normal(ULN)
Serum total bilirubin > 2.0 mg/dL (34.2 μmol/L); or ≥ 3.0 x upper limit of normal (ULN) for subjects with hereditary benign hyperbilirubinemia.
6. Subjects with any one of the following:
Congestive heart failure (New York Heart Association Class III or IV)
Myocardial infarction within 12 months prior to starting study treatment
Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris 7. Peripheral neuropathy ≥ Grade 2. 8. Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ≥ 5 years. Exceptions include the following:
Basal or Squamous cell carcinoma of the skin
Carcinoma in situ of the cervix or breast
Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b) 9. Known infection with human immunodeficiency virus (HIV) antibody positive, hepatitis B virus surface antigen (HBsAg) positive or hepatitis C virus antibody (HCVAb) positive. If negative for hepatitis B virus surface antigen (HBsAg) but hepatitis B core antibody (HBcAb) and/or hepatitis B surface antibody (HBsAb) positive status, a hepatitis B virus DNA test will be performed and if positive the subject will be excluded.
10. Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide.
11. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
12. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
13. Any condition that confounds the ability to interpret data from the study. 14. Previous therapy with pomalidomide. 15. Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment.
16. Subjects with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis, and lupus, which likely need additional steroid or immunosuppressive treatments in addition to the study treatment. Includes subjects receiving corticosteroids (> 10 mg/day of prednisone or equivalent) within 3 weeks prior to enrollment.
17. Subjects who received any of the following within the last 14 days of initiation of study treatment:
Plasmapheresis
Major surgery (kyphoplasty is not considered major surgery)
Radiation therapy
Use of any antimyeloma drug therapy. 18. Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least 4 weeks prior to initiation of study treatment and are currently dependent on such treatment.
19. Subjects who are planning for or who are eligible for stem cell transplant.
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| Name | Affiliation | Role |
|---|---|---|
| Toru Sasaki, Director | Celgene K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celgene Trial Site | Nagoya | Aichi-ken | 467-8602 | Japan | ||
| Celgene Trial Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27096106 | Derived | Ichinohe T, Kuroda Y, Okamoto S, Matsue K, Iida S, Sunami K, Komeno T, Suzuki K, Ando K, Taniwaki M, Tobinai K, Chou T, Kaneko H, Iwasaki H, Uemura C, Tamakoshi H, Zaki MH, Doerr T, Hagiwara S. A multicenter phase 2 study of pomalidomide plus dexamethasone in patients with relapsed and refractory multiple myeloma: the Japanese MM-011 trial. Exp Hematol Oncol. 2016 Apr 18;5:11. doi: 10.1186/s40164-016-0040-7. eCollection 2015. |
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Treatment phase discontinuation occurred when a participant had confirmed progressive disease, development of unacceptable toxicity, voluntary withdrawal or met other criteria for treatment discontinuation.
All study participants who were on pomalidomide were transferred to the post-marketing study and continued the study treatment when pomalidomide became commercially available.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pomalidomide Plus Dexamethasone | Pomalidomide 4 mg by mouth (PO) daily (QD) on Days 1-21 of each 28-day cycle. Dexamethasone 40 mg PO once daily on Days 1, 8, 15, 22 of each 28-day cycle for those who are ≤ 75 years of age Dexamethasone 20 mg PO once daily on Days 1, 8, 15, 22 of each 28-day cycle for those who are > 75 years of age |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Dexamethasone | Drug | 40 mg or 20 mg oral dexamethasone once daily on Days 1, 8, 15, 22 of each 28-day cycle |
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| From first dose until the data cut-off date of 03 September 2014; maximum time in follow-up was 36.0 weeks |
| Time to Response | Time to response was calculated as the time from the first dose to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: 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; PR: ≥ 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 is also required. | From the first dose until the data cut-off date of 03 September 2014. Maximum time on follow-up was 36.0 weeks. |
| Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria (Later Cut-off Date) | Myeloma response was defined as a best overall response of complete response (CR) or partial response (PR) CR is defined as: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions. | From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks |
| Time to Response (Later Cut-off Date) | Time to response was calculated as the time from the first dose to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: 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; PR: ≥ 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 is also required. | From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks |
| Kaplan-Meier Estimates of Duration of Response | Duration of response (calculated for responders only) was defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria. | From first dose until the data cut-off date of 03 September 2014; maximum time for follow-up was 36 weeks |
| Kaplan-Meier Estimates of Duration of Response (Later Cut-off Date) | Duration of response (calculated for responders only) was defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria. | From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks |
| Kaplan-Meier Estimates of Progression-free Survival (PFS) | PFS was calculated as the time from the first dosing to the first documented progressive disease, as determined by the investigators based on the IMWG Uniform Response criteria, or death, whichever occurred earlier | From the first dose until the data cut-off date of 03 September 2014; maximum time on treatment was 36.0 weeks |
| Kaplan-Meier Estimates of PFS (Later Cut-off Date) | PFS was calculated as the time from the first dosing to the first documented progressive disease, as determined by the investigators based on the IMWG Uniform Response criteria, or death, whichever occurred earlier | From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks |
| Number of Participants With Adverse Events | Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the first treatment of the study medication and within 28 days after the last dose. | From first dose of study drug to final data cut-off date of 25 Sept 2015, maximum duration on treatment was 80.9 weeks |
| Kamogawa |
| Chiba |
| 298-8602 |
| Japan |
| Celgene Trial Site | Fukuoka | Fukuoka | 812-8582 | Japan |
| Celgene Trial Site | Hiroshima | Hiroshima | 734-8551 | Japan |
| Celgene Trial Site | Mito | Ibaragi | 311-3193 | Japan |
| Celgene Trial Site | Isehara | Kanagawa | 259-1193 | Japan |
| Celgene Trial Site | Kyoto | Kyoto | 602-8566 | Japan |
| Celgene Trial Site | Niigata | Niigata | 951-8566 | Japan |
| Celgene Trial Site | Okayama | Okayama-ken | 701-1192 | Japan |
| Celgene Trial Site | Osaka | Osaka | 543-8555 | Japan |
| Celgene Trial Site | Tokyo | Tokyo | 104-0045 | Japan |
| Celgene Trial Site | Tokyo | Tokyo | 150-8935 | Japan |
| Celgene Trial Site | Tokyo | Tokyo | 160-8582 | Japan |
| Celgene Trial Site | Tokyo | Tokyo | 162-8655 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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Safety Population included all participants who received at least one dose of study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | Pomalidomide Plus Dexamethasone | Pomalidomide: 4 mg oral pomalidomide once daily Days 1-21 of each 28-day cycle Dexamethasone: 40 mg or 20 mg oral dexamethasone once daily on Days 1, 8, 15, 22 of each 28-day cycle |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| Age, Continuous | Median | Full Range | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Time from first diagnosis | Median | Full Range | years |
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| Durie-Salmon Multiple myeloma staging at screening | Stages are: Stage I: Hemoglobin > 10 g/dL Serum calcium normal On roentgenogram, normal bone structure or solitary bone plasmacytoma only Low M-component production rates (IgG value < 5 g/dL, IgA value < 3 g/dL, Bence Jones protein < 4 g/24h) Stage II: Overall data as minimally abnormal for stage I, and no single value as abnormal as defined for stage III Stage III: 1 or more of below: Hemoglobin < 8.5 g/dL Serum calcium > 12 mg/dL Advanced lytic bone lesions (scale 3) High-M-component production rates (IgG value > 7 g/dL, IgA value > 5 g/dL, Bence Jones protein > 12 g/24h) | Number | participants |
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| Eastern Cooperative Oncology Group Performance Status] (ECOG) | The ECOG scale is as follows: Grade 0: Fully active, able to carry on all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair. | Number | participants |
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| Prior Chemotherapy Regimens | The number of prior chemotherapy regimens for myeloma | Median | Full Range | regimens |
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| Prior Stem Cell Transplant for Myeloma | Number | participants |
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| Durie-Salmon Multiple Myeloma staging at screening | Stages are: Stage I: Hemoglobin > 10 g/dL Serum calcium normal On roentgenogram, normal bone structure or solitary bone plasmacytoma only Low M-component production rates (IgG value < 5 g/dL, IgA value < 3 g/dL, Bence Jones protein < 4 g/24h) Stage II: Overall data as minimally abnormal for stage I, and no single value as abnormal as defined for stage III Stage III: 1 or more of below: Hemoglobin < 8.5 g/dL Serum calcium > 12 mg/dL Advanced lytic bone lesions (scale 3) High-M-component production rates (IgG value > 7 g/dL, IgA value > 5 g/dL, Bence Jones protein > 12 g/24h) | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria | Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: 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; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required. | Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment. | Posted | Number | 95% Confidence Interval | percentage of participants responding | From the first dose until the data cut-off date of 03 Sept 2014; Maximum time in follow-up was 36.0 weeks. |
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| Secondary | Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria | Myeloma response was defined as a best overall response of complete response (CR) or partial response (PR) CR is defined as: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions. | Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment. | Posted | Number | 95% Confidence Interval | percentage of participants responding | From first dose until the data cut-off date of 03 September 2014; maximum time in follow-up was 36.0 weeks |
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| Secondary | Time to Response | Time to response was calculated as the time from the first dose to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: 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; PR: ≥ 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 is also required. | Included participants with at least a PR or better based on Assessment using IMWG criteria. | Posted | Median | Full Range | weeks | From the first dose until the data cut-off date of 03 September 2014. Maximum time on follow-up was 36.0 weeks. |
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| Primary | Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria (Later Cut-off Date) | Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: 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; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required. | Efficacy Evaluable Population (EEP) includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment. | Posted | Number | 95% Confidence Interval | percentage of participants responding | From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks |
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| Secondary | Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria (Later Cut-off Date) | Myeloma response was defined as a best overall response of complete response (CR) or partial response (PR) CR is defined as: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions. | EEP includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment. | Posted | Number | 95% Confidence Interval | percentage of participants responding | From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks |
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| Secondary | Time to Response (Later Cut-off Date) | Time to response was calculated as the time from the first dose to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: 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; PR: ≥ 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 is also required. | Included participants with at least a PR or better based on Assessment using IMWG criteria; EPP includes all participants who meet eligibility criteria, take at least one dose of study medication, and have a baseline and a post-baseline efficacy assessment. | Posted | Median | Full Range | weeks | From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks |
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| Secondary | Kaplan-Meier Estimates of Duration of Response | Duration of response (calculated for responders only) was defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria. | Duration of Response was not analyzed as there was insufficient data available at Cycle 2, Day 1 of study treatment. There was limited data evaluated and data were not analyzed. | Posted | From first dose until the data cut-off date of 03 September 2014; maximum time for follow-up was 36 weeks |
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| Secondary | Kaplan-Meier Estimates of Duration of Response (Later Cut-off Date) | Duration of response (calculated for responders only) was defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria. | Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment. | Posted | Median | 95% Confidence Interval | weeks | From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks |
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| Secondary | Kaplan-Meier Estimates of Progression-free Survival (PFS) | PFS was calculated as the time from the first dosing to the first documented progressive disease, as determined by the investigators based on the IMWG Uniform Response criteria, or death, whichever occurred earlier | Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment. | Posted | Median | 95% Confidence Interval | weeks | From the first dose until the data cut-off date of 03 September 2014; maximum time on treatment was 36.0 weeks |
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| Secondary | Kaplan-Meier Estimates of PFS (Later Cut-off Date) | PFS was calculated as the time from the first dosing to the first documented progressive disease, as determined by the investigators based on the IMWG Uniform Response criteria, or death, whichever occurred earlier | Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment. | Posted | Median | 95% Confidence Interval | weeks | From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks |
|
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| Secondary | Number of Participants With Adverse Events | Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the first treatment of the study medication and within 28 days after the last dose. | Safety population includes all participants who took at least one dose of study medication. | Posted | Number | participants | From first dose of study drug to final data cut-off date of 25 Sept 2015, maximum duration on treatment was 80.9 weeks |
|
From the start of study drug through 28 days after the last dose of study drug. Maximum duration of study treatment was 80.9 weeks; up to 25 September 2015 data cut-off
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 | Pomalidomide Plus Dexamethasone | Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression or pomalidomide discontinuation for any reason. | 16 | 36 | 36 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| PNEUMONIA PNEUMOCOCCAL | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| MULTI-ORGAN FAILURE | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| BLOOD FIBRINOGEN DECREASED | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| SHOCK HAEMORRHAGIC | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| MENINGITIS | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (16.1) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| PROCTALGIA | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| DECUBITUS ULCER | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HYPERSOMNIA | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HICCUPS | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA (16.1) | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA (16.1) | Systematic Assessment |
| |
| RESTLESSNESS | Psychiatric disorders | MedDRA (16.1) | Systematic Assessment |
| |
| INCREASED APPETITE | Metabolism and nutrition disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA (16.1) | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MedDRA (16.1) | Systematic Assessment |
| |
| HYPOGAMMAGLOBULINAEMIA | Immune system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
Disclosure agreements varied; the Investigators shall not disclose any material/information disclosed by the Sponsor (Celgene KK) with the clinical trial or information obtained by conducting the clinical trial to third parties without Sponsor's prior written approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne McClain, Senior Manager | Celgene Corporation | 888-260-1599 | ClinicalTrialDisclosure@Celgene.com |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C467566 | pomalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Stage III |
|
| Title | Measurements |
|---|
|
| 2 = (Ambulatory but unable to work) |
|
| 3 = (Limited self-care) |
|
| 4 = (Completely disabled) |
|
| Title | Measurements |
|---|---|
|
| Stage III |
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|