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
Not provided
Not provided
The purpose of this study is to investigate whether lenalidomide would reduce the number of red blood cell transfusions (RBC) needed in anemic (RBC transfusion-dependent) participants with low or intermediate-1 risk MDS without a deletion 5q chromosome abnormality. The study also investigated the safety of lenalidomide use in these participants. Two-thirds of the participants received oral lenalidomide and one-third of the participants received oral placebo.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm #1 - Lenalidomide plus placebo | Experimental | Lenalidomide 10 mg by mouth (PO) daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min. |
|
| Arm #2 - placebo | Placebo Comparator | Three placebo capsules once daily for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | One 10 mg Lenalidomide capsule + 2 placebo capsules or (3 placebo capsules) once daily for subjects with a creatinine clearance ≥ 60 mL/min. Alternatively-one 5 mg Lenalidomide capsule + 2 placebo capsules (or 3 placebo capsules) once daily for subjects with a creatinine clearance between 40 and 60 mL/min. Subjects may take study drug for at least 168 days unless there are intolerable side effects or disease progresses. Subjects may continue study drug beyond 168 days if they have an erythroid response (increase in their hemoglobin levels and fewer transfusions administered than before starting study drug) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for ≥ 56 Days as Determined by an Independent Review Committee (IRC) | The percentage of participants who achieved the 56-day RBC transfusion independent (TI) response was defined as the absence of any RBC transfusions during any consecutive "rolling" 56-day interval within the double-blind treatment phase (ie, Days 2 (Day 1 is the first study drug day) to 57, Days 3 to 58, etcetera). The double-blind treatment phase was defined as the period between the 1st dosing up until 28 days after the last study drug dose | From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively. |
| Percentage of Participants With a Erythroid Gene Signature Who Achieved RBC Transfusion Independence for ≥ 56 Days as Determined by an Independent Review Committee (IRC) | The percentage of participants who achieved the 56-day RBC TI response was defined as the absence of any RBC transfusions during any consecutive "rolling" 56-day interval within the double-blind treatment phase (ie, Days 2 (Day 1 is the first study drug day) to 57, Days 3 to 58, etcetera). A participant who achieved at least a 56-day RBC-transfusion-independent response was considered a 56-day RBC-TI responder. | From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved RBC Transfusion Independence With a Duration of ≥ 24 Weeks (168 Days) as Determined by the Sponsor | The 168-day RBC-transfusion-independent response was defined as the absence of any RBC transfusion during any consecutive "rolling" 168 days during the treatment period, for example Days 2 (Day 1 is the first study drug day) to 169, Days 3 to 170, Days 4 to 171, etcetera. A responder was defined as a participant who had a ≥ 168 consecutive days of RBC-transfusion-free period after the first dose of study drug in the treatment phase. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Albert Hoenekopp, MD | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at Los Angeles | Los Angeles | California | 90095 | United States | ||
| Southern Illinois Hematology Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27354480 | Result | Santini V, Almeida A, Giagounidis A, Gropper S, Jonasova A, Vey N, Mufti GJ, Buckstein R, Mittelman M, Platzbecker U, Shpilberg O, Ram R, Del Canizo C, Gattermann N, Ozawa K, Risueno A, MacBeth KJ, Zhong J, Seguy F, Hoenekopp A, Beach CL, Fenaux P. Randomized Phase III Study of Lenalidomide Versus Placebo in RBC Transfusion-Dependent Patients With Lower-Risk Non-del(5q) Myelodysplastic Syndromes and Ineligible for or Refractory to Erythropoiesis-Stimulating Agents. J Clin Oncol. 2016 Sep 1;34(25):2988-96. doi: 10.1200/JCO.2015.66.0118. Epub 2016 Jun 27. | |
| 32064987 |
Not provided
Not provided
Participants must have had transfusion-dependent anemia defined as having an average transfusion need of at least 2 units of packed red blood cells (pRBCs) per 28 days during the 112 days preceding randomization; No consecutive 56-day period that was RBC-transfusion-free during the 112 days preceding randomization; hemoglobin levels ≤ 9.5 g/dL.
239 participants were randomized at sites located in Europe (185), North America (24), Asia/Pacific (13) and the Middle East (17).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received 3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent. |
| FG001 | Lenalidomide |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Placebo | Other | 3 placebo capsules once daily. Subjects may take study drug for at least 168 days unless there are intolerable side effects or disease progresses. Subjects may continue study drug beyond 168 days if they have an erythroid response (increase in their hemoglobin levels and fewer transfusions administered than before starting study drug) |
|
| From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively. |
| Kaplan Meier Estimates of Duration of 56-day RBC Transfusion Independence Response as Determined by the Sponsor | The duration of the first 56-day RBC transfusion-independence response was calculated for those who achieved a response and was dependent on whether a subsequent RBC transfusion was given after the transfusion-free period (response):
| Response was assessed up to the end of treatment; up to the data cut-off date of 17 Mar 2014. |
| Percentage of Participants Who Achieved an Erythroid Response Based on the Modified International Working Group (IWG) 2006 Criteria | A participant was considered as having achieved an erythroid response if the participant either: - had a hemoglobin (Hgb) increase ≥1.5 g/dL compared to baseline and confirmed by another central laboratory hemoglobin value at 4 to 8 weeks after the first Hgb measurement that also increased ≥1.5 g/dL. All Hgb values during this time interval must have had a ≥ 1.5 g/dL increase (ie, no central laboratory Hgb increase during this timeframe could be less <1.5 g/dL) OR - had a 50% reduction in the number of the RBC transfusion units over any consecutive 56 days period compared to the baseline transfusion burden. The baseline transfusion burden is the number of units over 112 days by the randomization divided by 2. Only transfusions given for a pre-transfusion Hgb value of 9 g/dL or less were used in this response assessment. | From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively. |
| Time to 56-Day RBC-Transfusion-Independent (TI) Response as Determined by the Sponsor | The time to the first 56-day RBC-transfusion-independent response was calculated for participants who achieved a response. The day from the first dose of study drug to the date at which RBC-transfusion-independence starts was achieved and calculated using: Start date of the first response period - the date of the first study drug +1. A responder was defined as a participant who had a ≥ 56 consecutive days of RBC-transfusion-free period after the first dose of study drug in the treatment phase. | From first dose of study drug until 28 days after the last dose of study drug, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively. |
| Kaplan Meier Estimates for Progression to Acute Myeloid Leukemia (AML) | Progression to AML is part of the natural course of MDS and is a manifestation of disease progression. The time to progress to AML was calculated from the day of randomization to the first day when AML was diagnosed. Participants who died without AML were censored at the date of death. The participants who were lost to follow-up were censored at the last known day when participants did not have AML. Participants who did not progress to AML at the last follow-up contact were censored at the day of the last follow-up contact. | From randomization to final data cut-off date of 03 Jul 2018; median follow up time for progression to AML was 2.3 years (range = 0 to 5.0 years) in the placebo arm and 2.6 years (range = 0 to 6.4 years) in the lenalidomide arm. |
| Kaplan Meier Estimate for Overall Survival (OS) | Overall survival was assessed using the time between randomization and the date of death or date of censoring. Participants who were alive at a data cutoff date and participants who were lost to follow-up were censored at the last date when participants were known to be alive. | From randomization to final data cut-off date of 03 July 2018; maximum survival follow up was 6.4 years |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | A TEAE was defined as an AE that begins or worsens in intensity of frequency on or after the first dose of study drug through 28 days after last dose of study drug. A serious adverse event (SAE) is any:
The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death. | From the first dose of study drug through 28 days after discontinuation from the study treatment; up to the final data cut-off date of 03 July 2018; maximum exposure was 2100 days in the lenalidomide arm and 529 days in the placebo arm. |
| Compliance Rates Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) From Baseline to Week 48 | The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A participant was considered compliant at a visit if at least 15 out of the QLQ-C30 items in the questionnaire were checked. | Baseline, Week 12, (±3 days), Week 24, (±3 days), Week 36, (±3 days), and Week 48 (±3 days); up to data cut-off of 17 Mar 2014 |
| Mean Change From Baseline in the EORTC QLQ-C30 Fatigue Domain at Week 12 and 24 | 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 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom). | Baseline and Week 12, ±3 days and Week 24, ±3 days |
| Mean Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain at Week 12 and 24 | 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 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom). | Baseline and Week 12, ±3 days and Week 24, ±3 days |
| Mean Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain at Week 12 and 24 | 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 Physical Functioning Scale was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Baseline and Week 12, ±3 days and Week 24, ±3 days |
| Mean Change From Baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life (QOL) Domain at Week 12 and 24 | 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 was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement. | Baseline and Week 12, ±3 days and Week 24, ±3 days |
| Mean Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain at Week 12 and 24 | 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 Emotional Functioning Domain was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Baseline and Week 12, ±3 days and Week 24, ±3 days |
| Mean Change From Baseline in Fatigue Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24 | The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). 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 reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom). | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| Mean Change From Baseline in the Dyspnea Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24 | 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 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom). | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| Mean Change From Baseline in the Physical Functioning Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24 | The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). The EORTC QLQ-C30 Physical Functioning was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement. | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| Mean Change From Baseline in the Global Health Status/QoL Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24 | The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement. | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| Mean Change From Baseline in the Emotional Functioning Domain Associated With the EORTC QLQ-C30 Scale at Weeks 12 and 24 | 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 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| Percentage of Participants With a Clinically Meaningful Improvement in QOL (EORTC QLQ-C-30 Scale) From Baseline in Fatigue Domain at Weeks 12 and 24 | The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. Improvement means at least 10 points better compared to baseline | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Dyspnea Domain at Weeks 12 and 24 | 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 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom). Improvement means at least 10 points better compared to baseline. | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline Within the Physical Functioning Domain at Weeks 12 and 24 | The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A change of at least 10 points on the standardized domain scores was required for it to be considered clinically meaningful. | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Global Health Status/QOL Domain at Weeks 12 and 24 | The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A change of at least 10 points on the standardized domain scores was required for it to be considered clinically meaningful. | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Emotional Functioning Domain at Weeks 12 and 24 | 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 Emotional Functioning Domain was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Related to Adverse Events Per Person Year | Hospitalizations due to adverse events exclude those for transfusions, elective procedures or protocol-driven procedures. HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. | From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively. |
| Healthcare Resource Utilization (HRU): Duration of Hospitalizations Due to Adverse Events | Hospitalizations due to adverse events exclude those for transfusions, elective procedures or protocol-driven procedures. HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. | From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively. |
| Healthcare Resource Utilization (HRU): Number of Days of Hospitalization Due to Adverse Events Per Person-Years | Hospitalizations due to adverse events exclude those for transfusions, elective procedures or protocol-driven procedures. HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient | From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively. |
| Centralia |
| Illinois |
| 62801 |
| United States |
| Dartmouth Hitchcock Medical Center Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Wollongong Hospital | Wollongong | New South Wales | 2500 | Australia |
| Royal Adelaide Hospital Institute of Medical and Veterinary Science | Adelaide | South Australia | 5000 SA | Australia |
| Princess Alexandra Hospital | Woolloongabba | 4102 | Australia |
| Medizinische Universitat Innsbruck | Innsbruck | 6020 | Austria |
| Krankenhaus der Elisabethinen Linz, I Interne Abteilung | Linz | 4020 | Austria |
| Universitatsklinik fur Innere Medizin Salzburg | Salzburg | 5020 | Austria |
| Wiener Gebietskrankenkasse-Hanusch-Krankenhaus | Vienna | 1140 | Austria |
| Klinikum Wels-Grieskirchen GmbH | Weis | 4600 | Austria |
| AZ St-Jan Brugge Oostende AV | Bruges | 8000 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| Grand Hopital de Charleroi | Charleroi | 6000 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| Centre Hospitalier Universitaire de Liege | Liège | 4000 | Belgium |
| Center Hospitalier Universitaire Ambroise Pare | Mons | 7000 | Belgium |
| Cliniques Universitaires UCL de Mont-Godine | Namur | 5530 | Belgium |
| Tom Baker Cancer Center | Calgary | Alberta | T2N 4N2 | Canada |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| Cancer Care Manitoba | Winnepeg | Manitoba | R3E 0V9 | Canada |
| Sunnybrook Regional Cancer Center | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Hospital and University of Toronto | Toronto | Ontario | M5G 2M9 | Canada |
| Maisonneuve Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| McGill University, Dept. Oncology Clinical Research Program | Montreal | Quebec | H2W 1S6 | Canada |
| Hopital du Sacre-Coeur de Montreal | Montreal | Quebec | H4J 1C5 | Canada |
| Fakultni nemocnice Brno | Brno | 625 00 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 77520 | Czechia |
| Ustav hematologie a krevni transfuze | Prague | 128 20 | Czechia |
| Vseobecna Fakultni Nemocnice v Praze | Prague | 12808 | Czechia |
| CHU d'Angers | Angers | 49033 | France |
| Hopital Avicenne | Bobigny | 93009 | France |
| Hopital A. Michallon | La Tronche | 38700 | France |
| CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang | Lille | 59037 | France |
| Institut Paoli-Calmettes | Marseille | 13273 | France |
| Groupe hospitalier Cochin Saint-Vincent de Paul | Paris | 75679 | France |
| Universitat zu Koln | Cologne | 50924 | Germany |
| BAG Freiberg-Richter, Jacobash, Illmer, Wolf | Dresden | 1307 | Germany |
| Sankt Johannes Hospital Duisburg | Duisberg | 47166 | Germany |
| Universitätsklinikum Düsseldorf | Düesseldorf | 40211 | Germany |
| Marien Hospital | Düsseldorf | 40479 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Klinikum Mannheim der Universitat Heidelberg | Heidelberg | 69120 | Germany |
| Universitatsklinikum Mannheim | Mannheim | 68135 | Germany |
| TU München - Klinikum rechts der Isar | München | 81675 | Germany |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| Tel-Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| The Chaim Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
| Az. Osp. SS.Antonio e Biagio - SC Ematologia | Alessandria | 15100 | Italy |
| A.O.U. di Bologna Policlinico S.Orsola-Malpighi | Bologna | 40138 | Italy |
| P.O. Ospedale Roberto Binaghi (UNI CA/ASL 8) | Cagliari | 09100 | Italy |
| Azienda Ospedaliero-Universitaria di Cagliari | Cagliari | 09121 | Italy |
| Azienda Ospedaliero-Universitaria Careggi | Florence | 50139 | Italy |
| Azienda Ospedaliera Cardarelli | Naples | 80131 | Italy |
| AOU San Luigi Gonzaga | Orbassano | 10043 | Italy |
| IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture | Rionero in Vulture | Italy |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Roma | 00133 | Italy |
| Azienda Policlinico Umberto I, Universita La Sapienzadi Roma | Roma | 00161 | Italy |
| Policlinico Agostino Gemelli - Istituto di Ematologia | Roma | 00168 | Italy |
| Policlinico Univeristario di Udine | Udine | 33100 | Italy |
| Hiroshima University Hospital | Hiroshima | Japan |
| Tokai University School of Medicine | Isehara City, Kanagawa | 259-1193 | Japan |
| Kameda General Hospital | Kamogawa | 296-8602 | Japan |
| Kanazawa University Hospital | Kanazawa | Japan |
| Nagasaki Unversity Hospital | Nagasaki | Japan |
| National Hospital Organization Nagoya Medical Center | Nagoya | 460-0001 | Japan |
| Osaka Red Cross Hospital | Osaka | Japan |
| Tohoku University Hospital | Sendai | 980-8574 | Japan |
| Japanese Red Cross Medical Center | Shibuya City | 150-8935 | Japan |
| Jichi Medical University Hospital | Shimotsuke | Japan |
| Kanto Medical Center NTT EC | Shinagawa City | Japan |
| Katedra i Klinika Hematologii i Transplantacji Szpiku - SLASKIEGO UNIWERSYTETU MEDYCZNEGO | Gdansk | 80-119 | Poland |
| Uniwersytet Medyczny w Lodzi | Lodz | 93-510 | Poland |
| Instytut Hematologii i Transfuzjologii, Klinika Hematologii | Warsaw | 02-776 | Poland |
| Hospitais da Universidade de Coimbra | Coimbra | 3000-075 | Portugal |
| Instituto Portugues de Oncologia de Lisboa | Lisbon | 1090-023 | Portugal |
| Hospital Geral de Santo Antonio | Porto | 4099-001 | Portugal |
| Hospital Clinic Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Son Llatzer | Palma de Mallorca | 7198 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
| Hospital Universitario La Fe | Valencia | 46009 | Spain |
| Gazi Universitesi Tip Fakltesi | Ankara | 06500 | Turkey (Türkiye) |
| Akdeniz Universitesi Tip Fakultesi | Antalya | 07503 | Turkey (Türkiye) |
| Istanbul Universitesi Istanbul | Istanbul | 34390 | Turkey (Türkiye) |
| Dokuz Eylul Universitesi Tip Faiultesi | Izimir | 35340 | Turkey (Türkiye) |
| Royal Bournemouth Hospital | Bournemouth | BH7 7DW | United Kingdom |
| University Hospital of Wales | Cardiff | CF14 4XN | United Kingdom |
| Saint James University Hospital | Leeds | LS9 7TF | United Kingdom |
| Barts Cancer Institute, Queen Mary University of London, Charterhouse Square | London | EC1A 7BE | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| Christie Hospital | Manchester | M20 4BX | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| Derived |
| Santini V, Almeida A, Giagounidis A, Skikne B, Beach CL, Weaver J, Tu N, Fenaux P. Achievement of red blood cell transfusion independence in red blood cell transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes correlates with serum erythropoietin levels. Leuk Lymphoma. 2020 Jun;61(6):1475-1483. doi: 10.1080/10428194.2020.1719088. Epub 2020 Feb 17. |
| 29322849 | Derived | Almeida A, Fenaux P, Garcia-Manero G, Goldberg SL, Gropper S, Jonasova A, Vey N, Castaneda C, Zhong J, Beach CL, Santini V. Safety profile of lenalidomide in patients with lower-risk myelodysplastic syndromes without del(5q): results of a phase 3 trial. Leuk Lymphoma. 2018 Sep;59(9):2135-2143. doi: 10.1080/10428194.2017.1421758. Epub 2018 Jan 11. |
Participants received lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Participants received lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent-to-Treat (ITT) population includes all participants who were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received 3 placebo capsules by mouth daily for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent. |
| BG001 | Lenalidomide | Participants receieved lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min. |
| BG002 | 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 | Count of Participants | Participants |
| ||||||||||||||||
| Packed RBC (pRBC) Transfusion Burden | The baseline transfusion burden is the average number of RBC units/28 days during the 112 days prior to randomization. | Mean | Standard Deviation | pRBC units/28 days |
| ||||||||||||||
| International Prognostic Scoring System (IPSS) Investigator Determined | The Myelodysplastic Syndrome (MDS) IPSS score assesses the severity of MDS based on 3 prognostic factors each assigned a score: the percentage of bone marrow blasts, chromosome changes in the marrow cells (karyotype) and the presence of one or more low blood cell counts (cytopenias). The IPSS score is the sum of the bone marrow blast + karyotype + cytopenia score and ranges from 0 (low risk) to 3.5 (high risk). Prognosis is categorized as Low risk (score = 0), Intermediate-1 (score 0.5 to 1.0), Intermediate-2 (score 1.5 to 2.0) or High risk (score ≥ 2.5). | Count of Participants | Participants |
| |||||||||||||||
| World Health Organization Classification 2008 of MDS by Central Review | The World Health Organization (WHO) 2008 classification recognizes eight subtypes of MDS that are distinguished by the percentage of myeloblasts, presence or absence of ringed sideroblasts (i.e., erythroid precursors with iron deposits surrounding the nucleus), presence of a monocytosis or a deletion 5q. | Count of Participants | Participants |
| |||||||||||||||
| Prior Erythropoiesis-stimulating Agent (ESA) Treatment | Erythropoiesis-stimulating agents (ESA) are similar to the cytokine (erythropoietin) that stimulates red blood cell production (erythropoieisis). ESAs, structurally and biologically, are similar to naturally occurring protein erythropoietin. ESAs are used to maintain hemoglobin at the lowest level that both minimizes transfusions and best meets a person's needs | Count of Participants | Participants |
| |||||||||||||||
| Hemoglobin | Mean | Standard Deviation | g/dL |
| |||||||||||||||
| Gene Expression Signature | A prespecified subgroup of participants with an erythroid differentiation gene expression signature predictive of lenalidomide response | Count of Participants | 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 | Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for ≥ 56 Days as Determined by an Independent Review Committee (IRC) | The percentage of participants who achieved the 56-day RBC transfusion independent (TI) response was defined as the absence of any RBC transfusions during any consecutive "rolling" 56-day interval within the double-blind treatment phase (ie, Days 2 (Day 1 is the first study drug day) to 57, Days 3 to 58, etcetera). The double-blind treatment phase was defined as the period between the 1st dosing up until 28 days after the last study drug dose | The Intent-to-Treat (ITT) population includes all participants who were randomized to either lenalidomide or placebo. | Posted | Number | percentage of participants | From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively. |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With a Erythroid Gene Signature Who Achieved RBC Transfusion Independence for ≥ 56 Days as Determined by an Independent Review Committee (IRC) | The percentage of participants who achieved the 56-day RBC TI response was defined as the absence of any RBC transfusions during any consecutive "rolling" 56-day interval within the double-blind treatment phase (ie, Days 2 (Day 1 is the first study drug day) to 57, Days 3 to 58, etcetera). A participant who achieved at least a 56-day RBC-transfusion-independent response was considered a 56-day RBC-TI responder. | Analysis population includes ITT participants with an erythroid gene expression signature. | Posted | Number | percentage of participants | From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved RBC Transfusion Independence With a Duration of ≥ 24 Weeks (168 Days) as Determined by the Sponsor | The 168-day RBC-transfusion-independent response was defined as the absence of any RBC transfusion during any consecutive "rolling" 168 days during the treatment period, for example Days 2 (Day 1 is the first study drug day) to 169, Days 3 to 170, Days 4 to 171, etcetera. A responder was defined as a participant who had a ≥ 168 consecutive days of RBC-transfusion-free period after the first dose of study drug in the treatment phase. | The ITT population includes all participants who were randomized to either lenalidomide or placebo. | Posted | Number | percentage of participants | From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan Meier Estimates of Duration of 56-day RBC Transfusion Independence Response as Determined by the Sponsor | The duration of the first 56-day RBC transfusion-independence response was calculated for those who achieved a response and was dependent on whether a subsequent RBC transfusion was given after the transfusion-free period (response):
| The analysis was conducted only for those participants who achieved a 56-day transfusion independence response according to the sponsor's assessment. Responders in the intent to treat population. | Posted | Median | 95% Confidence Interval | weeks | Response was assessed up to the end of treatment; up to the data cut-off date of 17 Mar 2014. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved an Erythroid Response Based on the Modified International Working Group (IWG) 2006 Criteria | A participant was considered as having achieved an erythroid response if the participant either: - had a hemoglobin (Hgb) increase ≥1.5 g/dL compared to baseline and confirmed by another central laboratory hemoglobin value at 4 to 8 weeks after the first Hgb measurement that also increased ≥1.5 g/dL. All Hgb values during this time interval must have had a ≥ 1.5 g/dL increase (ie, no central laboratory Hgb increase during this timeframe could be less <1.5 g/dL) OR - had a 50% reduction in the number of the RBC transfusion units over any consecutive 56 days period compared to the baseline transfusion burden. The baseline transfusion burden is the number of units over 112 days by the randomization divided by 2. Only transfusions given for a pre-transfusion Hgb value of 9 g/dL or less were used in this response assessment. | The ITT population includes all participants who were randomized to either lenalidomide or placebo. | Posted | Number | percentage of participants | From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to 56-Day RBC-Transfusion-Independent (TI) Response as Determined by the Sponsor | The time to the first 56-day RBC-transfusion-independent response was calculated for participants who achieved a response. The day from the first dose of study drug to the date at which RBC-transfusion-independence starts was achieved and calculated using: Start date of the first response period - the date of the first study drug +1. A responder was defined as a participant who had a ≥ 56 consecutive days of RBC-transfusion-free period after the first dose of study drug in the treatment phase. | The analysis was conducted only for those participants who achieved a 56-day TI response according to the sponsor's assessment. Responders in the intent to treat population. | Posted | Median | Full Range | weeks | From first dose of study drug until 28 days after the last dose of study drug, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan Meier Estimates for Progression to Acute Myeloid Leukemia (AML) | Progression to AML is part of the natural course of MDS and is a manifestation of disease progression. The time to progress to AML was calculated from the day of randomization to the first day when AML was diagnosed. Participants who died without AML were censored at the date of death. The participants who were lost to follow-up were censored at the last known day when participants did not have AML. Participants who did not progress to AML at the last follow-up contact were censored at the day of the last follow-up contact. | ITT population includes all participants who were randomized and received either lenalidomide or placebo. One participant in the placebo arm was diagnosed as having AML before enrollment and was excluded from all analyses of progression to AML. | Posted | Median | 95% Confidence Interval | years | From randomization to final data cut-off date of 03 Jul 2018; median follow up time for progression to AML was 2.3 years (range = 0 to 5.0 years) in the placebo arm and 2.6 years (range = 0 to 6.4 years) in the lenalidomide arm. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan Meier Estimate for Overall Survival (OS) | Overall survival was assessed using the time between randomization and the date of death or date of censoring. Participants who were alive at a data cutoff date and participants who were lost to follow-up were censored at the last date when participants were known to be alive. | The ITT population includes all participants who were randomized to either lenalidomide or placebo. | Posted | Median | 95% Confidence Interval | years | From randomization to final data cut-off date of 03 July 2018; maximum survival follow up was 6.4 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAE) | A TEAE was defined as an AE that begins or worsens in intensity of frequency on or after the first dose of study drug through 28 days after last dose of study drug. A serious adverse event (SAE) is any:
The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death. | Safety population includes all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From the first dose of study drug through 28 days after discontinuation from the study treatment; up to the final data cut-off date of 03 July 2018; maximum exposure was 2100 days in the lenalidomide arm and 529 days in the placebo arm. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Compliance Rates Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) From Baseline to Week 48 | The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A participant was considered compliant at a visit if at least 15 out of the QLQ-C30 items in the questionnaire were checked. | Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Data is available up to Week 48 due to small sample after that. | Posted | Number | percentage of participants | Baseline, Week 12, (±3 days), Week 24, (±3 days), Week 36, (±3 days), and Week 48 (±3 days); up to data cut-off of 17 Mar 2014 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the EORTC QLQ-C30 Fatigue Domain at Week 12 and 24 | 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 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom). | Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 12, ±3 days and Week 24, ±3 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain at Week 12 and 24 | 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 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom). | Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 12, ±3 days and Week 24, ±3 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain at Week 12 and 24 | 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 Physical Functioning Scale was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 12, ±3 days and Week 24, ±3 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life (QOL) Domain at Week 12 and 24 | 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 was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement. | Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 12, ±3 days and Week 24, ±3 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain at Week 12 and 24 | 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 Emotional Functioning Domain was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 12, ±3 days and Week 24, ±3 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Fatigue Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24 | The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). 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 reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom). | Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the Dyspnea Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24 | 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 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom). | Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the Physical Functioning Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24 | The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). The EORTC QLQ-C30 Physical Functioning was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement. | Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the Global Health Status/QoL Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24 | The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement. | Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the Emotional Functioning Domain Associated With the EORTC QLQ-C30 Scale at Weeks 12 and 24 | 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 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Clinically Meaningful Improvement in QOL (EORTC QLQ-C-30 Scale) From Baseline in Fatigue Domain at Weeks 12 and 24 | The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. Improvement means at least 10 points better compared to baseline | Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included. | Posted | Number | percentage of participants | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Dyspnea Domain at Weeks 12 and 24 | 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 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom). Improvement means at least 10 points better compared to baseline. | Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included. | Posted | Number | percentage of participants | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline Within the Physical Functioning Domain at Weeks 12 and 24 | The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A change of at least 10 points on the standardized domain scores was required for it to be considered clinically meaningful. | Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment with the EORTC QLQ-C-30. Only those with available data at baseline and each time point are included. | Posted | Number | percentage of participants | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Global Health Status/QOL Domain at Weeks 12 and 24 | The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A change of at least 10 points on the standardized domain scores was required for it to be considered clinically meaningful. | Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment with the EORTC QLQ-C-30. Only those with available data at baseline and each time point are included. | Posted | Number | percentage of participants | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Emotional Functioning Domain at Weeks 12 and 24 | 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 Emotional Functioning Domain was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. | Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point are included. | Posted | Number | percentage of participants | Baseline, Week 12, ±3 days and Week 24, ±3 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Percentage of Participants Who Achieved an Erythroid Response Based on Original IWG 2006 Criteria | A participant was considered as having achieved an erythroid response when: - a Hgb increase ≥1.5 g/dL compared to baseline and confirmed by another central laboratory hemoglobin value at 4 to 8 weeks after the first Hgb measurement that had also increased ≥1.5 g/dL for at least 8 weeks. All Hgb values during this time interval must have had a ≥ 1.5 g/dL increase (ie, no central laboratory Hgb increase during this timeframe can be less than a 1.5 g/dL) OR - had an absolute reduction of 4 RBC transfusion units over any consecutive 56 days period compared to the baseline transfusion burden. The baseline transfusion burden is the number of units over the 112 days prior to randomization divided by 2. Only transfusions given for a pre-transfusion Hgb value of 9.5 g/dL or less may be used in this response assessment. | Intent to treat population includes all participants who were randomized. | Posted | Number | percentage of participants | From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Related to Adverse Events Per Person Year | Hospitalizations due to adverse events exclude those for transfusions, elective procedures or protocol-driven procedures. HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. | Safety population includes all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | Hospitalizations per person-years | From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Healthcare Resource Utilization (HRU): Duration of Hospitalizations Due to Adverse Events | Hospitalizations due to adverse events exclude those for transfusions, elective procedures or protocol-driven procedures. HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. | Participants with at least one hospitalization. | Posted | Median | Full Range | Days | From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Healthcare Resource Utilization (HRU): Number of Days of Hospitalization Due to Adverse Events Per Person-Years | Hospitalizations due to adverse events exclude those for transfusions, elective procedures or protocol-driven procedures. HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient | Safety population includes all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | Days per person-years | From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively. |
|
From the first dose of study drug through 28 days after last dose; up to the final data cut-off date of 03 July 2018; maximum exposure was 2100 days in the lenalidomide treatment group and 529 days in the placebo group
Second primary malignancies were monitored as events of interest and reported as serious adverse events for at least 5 years from randomization unless the participants withdrew consent from the study, died or were lost to follow-up.
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 | Placebo | Participants received 3 placebo capsules by mouth QD for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent | 43 | 79 | 16 | 79 | 70 | 79 |
| EG001 | Lenalidomide | Participants received lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression or intolerable side effects. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance between 40 and 60 mL/min. | 94 | 160 | 62 | 160 | 154 | 160 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| HAEMOLYSIS | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| TACHYARRHYTHMIA | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| ULCERATIVE KERATITIS | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| GASTROINTESTINAL NECROSIS | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| INGUINAL HERNIA, OBSTRUCTIVE | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| PANCREATITIS NECROTISING | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| DISUSE SYNDROME | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| MULTI-ORGAN FAILURE | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| SUDDEN DEATH | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| ATYPICAL PNEUMONIA | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| BRONCHOPULMONARY ASPERGILLOSIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| ESCHERICHIA SEPSIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| LOBAR PNEUMONIA | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| NEUTROPENIC SEPSIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| PNEUMONIA VIRAL | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| PSEUDOMONAL SEPSIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| TOOTH ABSCESS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| SPINAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| THORACIC VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| TRAUMATIC INTRACRANIAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| RHABDOMYOLYSIS | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| ADENOCARCINOMA OF COLON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| CHRONIC MYELOMONOCYTIC LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| INVASIVE DUCTAL BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| LUNG SQUAMOUS CELL CARCINOMA STAGE IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| MYELODYSPLASTIC SYNDROME | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF LUNG | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF THE TONGUE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| DYSKINESIA | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| RENAL COLIC | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| NEURODERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| CIRCULATORY COLLAPSE | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| LEUKOPENIA | 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 |
| |
| CONJUNCTIVITIS | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| SERUM FERRITIN INCREASED | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| IRON OVERLOAD | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 12 months 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 90 days. Investigator must delete confidential information before submission or defer publication to permit patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne McClain, Senior Study Manager | Celgene Corporation | 888-260-1588 | clinicaltrialdisclosure@celgene.com |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| 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 |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| White |
|
| Japanese |
|
| Race Not Disclosed |
|
| Other |
|
| Intermediate 1 |
|
| Refractory cytopenia unilineage dysplasia (RCUD) |
|
| RA with ringed sideroblasts (RARS) |
|
| Refractory cytopenia multilineage dysplasia (RCMD) |
|
| Refractory anemia with excess blasts-1 (RAEB-1) |
|
| No |
|
|
|
|
|
|
|
| OG001 |
| Lenalidomide |
Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min. |
|
|
|
Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min. |
|
|
|
|
|
|
|
|
| Participants |
|
|
|
| Lenalidomide |
Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression or intolerable side effects. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance between 40 and 60 mL/min. . |
|
|
| OG001 | Lenalidomide | Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min. |
|
|
|
.Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.
|
|
|
.Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.
|
|
|
Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.
|
|
|
Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.
|
|
|
|
|
|
| OG001 | Lenalidomide | Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min. |
|
|
|
Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min. . |
|
|
|
| OG001 | Lenalidomide | Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min. . |
|
|
|
| OG001 | Lenalidomide | Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min. . |
|
|
|
Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.
.
|
|
|
| OG001 | Lenalidomide | Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min. |
|
|
|
| Lenalidomide |
Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min. . |
|
|
|
| OG001 | Lenalidomide | Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min. . |
|
|
|
| OG001 | Lenalidomide | Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min. . |
|
|
|
Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min. . |
|
|
|
Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.
Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|