Multiple Myeloma
Conditions
Keywords
newly diagnosed multiple myeloma, Lenalidomide, Revlimid, phase III
Brief summary
The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.
Detailed description
CC-5013-MM020/IFM 07-01 is a Phase III, multicenter, randomized, open-label, 3-arm study that will compare the efficacy and safety of two Lenalidomide plus low-dose dexamethasone regimens given for two different durations of time (i.e., until progressive disease \[PD\] or for up to a maximum of 18 four-week cycles) to that of MPT given for a maximum of 12 six-week cycles.
Interventions
DRUGLenalidomide and low-dose dexamethasone
Lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg 20mg, or 25 mg capsules, given either days 1-21 of each 28 day cycles or given every other day for 21 days until documentation of PD. Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle up to disease progression
DRUGLenalidomide plus low-dose dexamethasone given for 18 four-week cycles
lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg, 20 mg or 25 mg capsules given on days 1-21 of each 28 day cycle or every other day for 21 days for 18 cycles. Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle for 18 cycles
Melphalan - oral, 2mg tablets dosed at either 0.25mg/kg, 0.125 mg/kg, 0.20mg/kg or 0.10mg/kg on days 1-4 of each 42 day cycle up to 12 cycles Prednisone - oral, 5mg, 10mg, 20 mg and 50 mg tablets dosed at 2mg/kg daily days 1-4 of each 42 day cycle for up to 12 cycles Thalidomide - oral, 50mg, 100mg and 200 mg capsules dosed at either 100mg or 200 mg daily on days 1-41 of each 42 day cycle for up to 12 cycles
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must understand and voluntarily sign informed consent form 2. Age ≥ 18 years at the time of signing consent 3. Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below: * MM diagnostic criteria (all 3 required): * Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a biopsy-proven plasmacytoma * Monoclonal protein present in the serum and/or urine * Myeloma-related organ dysfunction (at least one of the following) \[C\] Calcium elevation in the blood (serum calcium \>10.5 mg/dl or upper limit of normal) \[R\] Renal insufficiency (serum creatinine \>2 mg/dl) \[A\] Anemia (hemoglobin \<10 g/dl or 2 g \< laboratory normal) \[B\] Lytic bone lesions or osteoporosis AND have measurable disease by protein electrophoresis analyses as defined by the following: * IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours * IgA multiple myeloma: Serum M-protein level ≥ 0.5 g/dl or urine M-protein level ≥ 200 mg/24 hours * IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200mg/24hours * IgD multiple myeloma: Serum M-protein level ≥ 0.05 g/dl or urine M-protein level ≥ 200 mg/24 hours * Light chain multiple myeloma: Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours AND are at least 65 years of age or older or, if younger than 65 years of age, are not candidates for stem cell transplantation because: * The patient declines to undergo stem cell transplantation or * Stem cell transplantation is not available to the patient due to cost or other reasons 4. ECOG performance status of 0, 1, or 2 5. Able to adhere to the study visit schedule and other protocol requirements 6. Females of child-bearing potential (FCBP)\^2: 1. Must agree to undergo two medically supervised pregnancy tests prior to starting study therapy with either Rd or MPT. The first pregnancy test will be performed within 10-14 days prior to the start of Rd or MPT and the second pregnancy test will be performed within 24 hours prior to the start of Rd or MPT. She must also agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the patient practices complete and continued sexual abstinence. 2. Must commit to either continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy. 7. Male Patients: 1. Must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy. 2. Must agree to not donate semen during study drug therapy and for a period after end of study drug therapy. 3. Must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy. 8. All patients must: 1. Have an understanding that the study drug could have a potential teratogenic risk. 2. Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy. 3. Agree not to share study medication with another person. All FCBP and male patients must be counseled about pregnancy precautions and risks of fetal exposure.
Exclusion criteria
1. Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid \[i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization\]). 2. Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment. 3. Pregnant or lactating females. 4. Any of the following laboratory abnormalities: * Absolute neutrophil count (ANC) \< 1,000/µL (1.0 x 109/L) * Untransfused platelet count \< 50,000 cells/µL (50 x 10\^9/L) * Serum SGOT/AST or SGPT/ALT \> 3.0 x upper limit of normal (ULN) 5. Renal failure requiring hemodialysis or peritoneal dialysis. 6. Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following: * Basal cell carcinoma of the skin * Squamous cell carcinoma of the skin * Carcinoma in situ of the cervix * Carcinoma in situ of the breast * Incidental histological finding of prostate cancer (TNM stage of T1a or T1b) 7. Patients who are unable or unwilling to undergo antithrombotic therapy. 8. Peripheral neuropathy of \> grade 2 severity. 9. Known HIV positivity or active infectious hepatitis, type A, B, or C. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis. * 1 A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification as myeloma if proven to be myeloma-related. * 2 A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (i.e., amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC) | From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months. | PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's). |
| Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis | From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months | PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm | Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. |
| Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months | Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first. |
| Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis | Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months | Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first. |
| Time to First Response Based on the Review by the IRAC | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm | The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria. |
| Time to First Response Based on the Investigator Assessment at the Time of Final Analysis | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm. | The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria assessed by the investigator. |
| Kaplan Meier Estimates of Time to Treatment Failure (TTF) | From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 16.1 months. | TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by IRAC based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death. |
| Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis | From date of randomization until the data cut-off date of 21 January 2016; median follow up for all participants was 16.1 months. | TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by the investigators assessment based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death. |
| Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT) | From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 23.0 months | Time to second-line anti-myeloma therapy was defined as time from randomization to the start of another non-protocol anti-myeloma therapy. |
| Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis | From date of randomization until the data cut-off of date 21 January 2016; median follow-up for all participants was 23.0 months | Time to second-line anti-myeloma therapy is defined as time from randomization to the start of another non-protocol anti-myeloma therapy. Those who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy. |
| Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis | Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm | Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. |
| Improvement of Infection Rate by Observing the Historical Data Compared to the Clinical Data Base | From randomization to 24 May 2013 | Improvement of infection rate by observing historical data compared to the data within clinical database as not analyzed. |
| Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review. | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm | Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. |
| Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm | Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. |
| Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm | Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. |
| Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm | Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. |
| Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement. |
| Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the future perspective scale, a higher score indicates a better perspective of the future. |
| Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. |
| Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. |
| Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. |
| Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | Cycle 1 Day 1, (Baseline) then Months 1, 3, 6, 12, 18 and Discontinuation visit | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. |
| Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. |
| Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. |
| Change From Baseline in the EORTC QLQ-C30 Pain Domain | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. |
| Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea/Vomiting Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. |
| Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. |
| Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. |
| Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Scale is scored between 0 and 100, with a high score indicating a higher level of appetite loss. Negative change from Baseline values indicate improvement in appetite and positive values indicate worsening of appetite. |
| Change From Baseline in the EORTC QLQ-C30 Constipation Domain | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Scale is scored between 0 and 100, with a high score indicating a higher level of constipation. Negative change from Baseline values indicate improvement in constipation and positive values indicate worsening of constipation. |
| Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Diarrhea Scale is scored between 0 and 100, with a high score indicating a higher level of diarrhea. Negative change from Baseline values indicate improvement in diarrhea and positive values indicate worsening of diarrhea. |
| Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit | The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Difficulties Scale is scored between 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicate improvement in financial difficulties and positive values indicate worsening of financial difficulties. |
| Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score indicates more severe disease symptom(s). |
| Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment. |
| Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit | EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the body image scale, a higher score indicates a better body image. |
| Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit | EQ-5D is a self-administered questionnaire that assesses health-related quality of life. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where higher EQ-5D scores represent better health status. A positive change from baseline score indicates improvement in health status and better health state. |
| Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year | Day 1 (randomization) up to last visit completed 25 July 2016 | HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of inpatient hospitalizations per patient year was calculated as the total number of hospitalizations divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient. |
| Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | From first dose of study drug through 28 days following the discontinuation visit from active treatment phase; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm | A TEAE is any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. |
| Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS) | From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months | Overall survival was defined as the time between randomization and death. Participants, who died, regardless of the cause of death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the participant was known to be alive. |
| Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm | Neutrophil counts was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. |
| Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm | Hemoglobin was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. |
| Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm | Improvement in platelets was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. |
| Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm | Renal function was assessed for participants from baseline to the most extreme value in creatinine clearance calculated using the Cockcroft-Gault estimation. |
| Percentage of Participants With an Objective Response Based on IRAC Review | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm | Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined as: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. |
Countries
Australia, Austria, Belgium, Canada, China, France, Germany, Greece, Ireland, Italy, New Zealand, Portugal, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
This study was conducted in the Europe, Asia, North America and Pacific regions. Participants were randomized at 246 sites (165 in Europe, 23 in Asia, 39 in North America, and 19 in the Pacific). The study was co-sponsored by Intergroupe Francophone du Myélome (IFM) (for sites in France, Switzerland, and Belgium) and Celgene Corporation.
Pre-assignment details
Participants were stratified at randomization by 1) age (≤ 75 versus \> 75 years), 2) stage (International Staging System Stages I or II versus Stage III), and 3) country.
Participants by arm
| Arm | Count |
|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. | 535 |
| Lenalidomide and Dexamethasone Rd18 Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. | 541 |
| Melphalan + Prednisone + Thalidomide (MPT) Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. | 547 |
| Total | 1,623 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Active Treatment Phase | Adverse Event | 68 | 71 | 76 |
| Active Treatment Phase | Death | 60 | 28 | 37 |
| Active Treatment Phase | Disease Progression | 273 | 362 | 339 |
| Active Treatment Phase | Lost to Follow-up | 0 | 2 | 2 |
| Active Treatment Phase | Miscellaneous | 52 | 34 | 47 |
| Active Treatment Phase | Protocol Violation | 2 | 2 | 4 |
| Active Treatment Phase | Study Close Out | 64 | 26 | 21 |
| Active Treatment Phase | Withdrawal by Subject | 16 | 16 | 21 |
| Long-Term Follow Up Phase | Continue in Long Term Follow Up | 127 | 188 | 144 |
Baseline characteristics
| Characteristic | Lenalidomide and Low-Dose Dexamethasone (Rd) | Lenalidomide and Dexamethasone Rd18 | Melphalan + Prednisone + Thalidomide (MPT) | Total |
|---|---|---|---|---|
| Age, Continuous | 73.2 years STANDARD_DEVIATION 6.57 | 72.9 years STANDARD_DEVIATION 6.5 | 73.1 years STANDARD_DEVIATION 6.32 | 73.1 years STANDARD_DEVIATION 6.46 |
| Albumin <=35 g/L | 192 Participants | 209 Participants | 223 Participants | 624 Participants |
| Albumin > 35 g/L | 343 Participants | 331 Participants | 324 Participants | 998 Participants |
| Albumin Missing | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Beta2 Microglobulin <=5.5 mg/L | 309 Participants | 316 Participants | 312 Participants | 937 Participants |
| Beta2 Microglobulin >5.5 mg/L | 224 Participants | 224 Participants | 234 Participants | 682 Participants |
| Beta2 Microglobulin Missing | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Creatinine clearance <60 ml/min | 266 Participants | 261 Participants | 261 Participants | 788 Participants |
| Creatinine clearance >=60 ml/min | 269 Participants | 280 Participants | 285 Participants | 834 Participants |
| Creatinine clearance Missing | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Cytogenetic Risk Adverse Risk | 170 Participants | 185 Participants | 189 Participants | 544 Participants |
| Cytogenetic Risk Favorable Hyperdiploidy | 112 Participants | 103 Participants | 102 Participants | 317 Participants |
| Cytogenetic Risk Missing | 33 Participants | 31 Participants | 31 Participants | 95 Participants |
| Cytogenetic Risk Normal | 148 Participants | 131 Participants | 141 Participants | 420 Participants |
| Cytogenetic Risk Not evaluable | 34 Participants | 35 Participants | 44 Participants | 113 Participants |
| Cytogenetic Risk Uncertain Risk | 38 Participants | 56 Participants | 40 Participants | 134 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 (fully active) | 155 Participants | 163 Participants | 156 Participants | 474 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 (restrictive but ambulatory) | 257 Participants | 263 Participants | 275 Participants | 795 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 2 (ambulatory but unable to work) | 119 Participants | 113 Participants | 111 Participants | 343 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 3-4 (limited self-care, completely disabled) | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Missing | 2 Participants | 0 Participants | 3 Participants | 5 Participants |
| International Staging System (ISS) Stage I | 106 Participants | 106 Participants | 103 Participants | 315 Participants |
| International Staging System (ISS) Stage II | 227 Participants | 229 Participants | 225 Participants | 681 Participants |
| International Staging System (ISS) Stage III | 202 Participants | 206 Participants | 219 Participants | 627 Participants |
| Lactic Dehydrogenase <200 U/L | 448 Participants | 442 Participants | 434 Participants | 1324 Participants |
| Lactic Dehydrogenase >=200 U/L | 86 Participants | 99 Participants | 112 Participants | 297 Participants |
| Lactic Dehydrogenase Missing | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Multiple Myeloma Subtype Immunoglobulin A | 138 Participants | 142 Participants | 123 Participants | 403 Participants |
| Multiple Myeloma Subtype Immunoglobulin A and Immunoglobulin G | 7 Participants | 6 Participants | 8 Participants | 21 Participants |
| Multiple Myeloma Subtype Immunoglobulin A and Immunoglobulin M | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Multiple Myeloma Subtype Immunoglobulin D | 4 Participants | 7 Participants | 4 Participants | 15 Participants |
| Multiple Myeloma Subtype Immunoglobulin G | 334 Participants | 331 Participants | 350 Participants | 1015 Participants |
| Multiple Myeloma Subtype Immunoglobulin M | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Multiple Myeloma Subtype Not available (includes light-chain disease) | 49 Participants | 54 Participants | 60 Participants | 163 Participants |
| Race/Ethnicity, Customized Asian | 40 Participants | 43 Participants | 44 Participants | 127 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants | 6 Participants | 5 Participants | 20 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 37 Participants | 33 Participants | 36 Participants | 106 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islanders | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 493 Participants | 505 Participants | 508 Participants | 1506 Participants |
| Race/Ethnicity, Customized Other, Miscellaneous | 6 Participants | 11 Participants | 3 Participants | 20 Participants |
| Race/Ethnicity, Customized Undisclosed | 5 Participants | 1 Participants | 3 Participants | 11 Participants |
| Race/Ethnicity, Customized White or Caucasian | 474 Participants | 480 Participants | 491 Participants | 1445 Participants |
| Sex: Female, Male Female | 241 Participants | 268 Participants | 260 Participants | 769 Participants |
| Sex: Female, Male Male | 294 Participants | 273 Participants | 287 Participants | 854 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 523 / 532 | 532 / 540 | 532 / 541 |
| serious Total, serious adverse events | 378 / 532 | 308 / 540 | 270 / 541 |
Outcome results
Primary
Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis
PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's).
Time frame: From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months
Population: The intent to treat population included all participants who were randomized, independent of whether they received study treatment or not.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis | 26.0 months |
| Lenalidomide and Dexamethasone Rd18 | Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis | 21.0 months |
| Melphalan + Prednisone + Thalidomide (MPT) | Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis | 21.9 months |
p-value: <0.0000195% CI: [0.59, 0.79]Log Rank
p-value: <0.0000195% CI: [0.6, 0.81]Log Rank
p-value: 0.9116195% CI: [0.86, 1.14]Log Rank
Primary
Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC)
PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's).
Time frame: From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months.
Population: The intent to treat (ITT) population included all participants who were randomized, independent of whether they received study treatment or not.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC) | 25.5 months |
| Lenalidomide and Dexamethasone Rd18 | Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC) | 20.7 months |
| Melphalan + Prednisone + Thalidomide (MPT) | Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC) | 21.2 months |
p-value: 0.0000695% CI: [0.61, 0.85]Log Rank
p-value: 0.0000195% CI: [0.6, 0.82]Log Rank
p-value: 0.7034995% CI: [0.89, 1.2]Log Rank
Secondary
Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Scale is scored between 0 and 100, with a high score indicating a higher level of appetite loss. Negative change from Baseline values indicate improvement in appetite and positive values indicate worsening of appetite.
Time frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Population: ITT population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | Month 1 | 1.3 units on a scale | Standard Deviation 33.46 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | Month 3 | -5.9 units on a scale | Standard Deviation 38.34 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | Month 6 | -9.8 units on a scale | Standard Deviation 40.02 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | Month 12 | -7.3 units on a scale | Standard Deviation 37.07 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | Month 18 | -8.1 units on a scale | Standard Deviation 35.97 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | Discontinuation Visit | -1.0 units on a scale | Standard Deviation 36.77 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | Discontinuation Visit | -7.5 units on a scale | Standard Deviation 37.49 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | Month 1 | 2.9 units on a scale | Standard Deviation 31.87 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | Month 12 | -6.4 units on a scale | Standard Deviation 35.3 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | Month 18 | -5.1 units on a scale | Standard Deviation 33.29 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | Month 3 | -3.3 units on a scale | Standard Deviation 35.25 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | Month 6 | -8.6 units on a scale | Standard Deviation 33.98 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | Month 3 | -6.2 units on a scale | Standard Deviation 35.03 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | Month 6 | -13.5 units on a scale | Standard Deviation 35.98 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | Discontinuation Visit | -2.6 units on a scale | Standard Deviation 37.18 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | Month 12 | -10.5 units on a scale | Standard Deviation 34.16 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | Month 1 | 1.0 units on a scale | Standard Deviation 32.35 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain | Month 18 | -12.2 units on a scale | Standard Deviation 31.88 |
Secondary
Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Time frame: Cycle 1 Day 1, (Baseline) then Months 1, 3, 6, 12, 18 and Discontinuation visit
Population: Intent to Treat (ITT) population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | Month 6 | -0.9 units on a scale | Standard Deviation 22.57 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | Month 1 | -1.2 units on a scale | Standard Deviation 21.73 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | Month 3 | -0.7 units on a scale | Standard Deviation 22.89 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | Month 12 | -1.6 units on a scale | Standard Deviation 25.05 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | Month 18 | -2.2 units on a scale | Standard Deviation 25.61 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | Discontinuation Visit | -4.9 units on a scale | Standard Deviation 27.57 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | Month 3 | 1.8 units on a scale | Standard Deviation 20.94 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | Month 6 | 0.9 units on a scale | Standard Deviation 19.77 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | Month 12 | -1.2 units on a scale | Standard Deviation 20.19 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | Discontinuation Visit | -2.6 units on a scale | Standard Deviation 22.34 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | Month 18 | -2.8 units on a scale | Standard Deviation 20.97 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | Month 1 | -1.7 units on a scale | Standard Deviation 19.08 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | Month 1 | -1.8 units on a scale | Standard Deviation 24.07 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | Month 18 | -0.7 units on a scale | Standard Deviation 23.99 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | Month 6 | -0.3 units on a scale | Standard Deviation 23.55 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | Discontinuation Visit | -7.1 units on a scale | Standard Deviation 25.15 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | Month 3 | -1.5 units on a scale | Standard Deviation 24.02 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain | Month 12 | -0.6 units on a scale | Standard Deviation 22.97 |
Secondary
Change From Baseline in the EORTC QLQ-C30 Constipation Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Scale is scored between 0 and 100, with a high score indicating a higher level of constipation. Negative change from Baseline values indicate improvement in constipation and positive values indicate worsening of constipation.
Time frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Population: ITT population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Constipation Domain | Month 1 | 8.3 units on a scale | Standard Deviation 36.74 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Constipation Domain | Month 3 | 1.8 units on a scale | Standard Deviation 37.53 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Constipation Domain | Month 6 | -2.4 units on a scale | Standard Deviation 37.51 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Constipation Domain | Month 12 | -2.4 units on a scale | Standard Deviation 38.79 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Constipation Domain | Month 18 | -4.5 units on a scale | Standard Deviation 35.42 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Constipation Domain | Discontinuation Visit | -7.9 units on a scale | Standard Deviation 39.98 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Constipation Domain | Discontinuation Visit | -7.5 units on a scale | Standard Deviation 39.2 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Constipation Domain | Month 1 | 6.3 units on a scale | Standard Deviation 36.18 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Constipation Domain | Month 12 | -5.2 units on a scale | Standard Deviation 38.09 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Constipation Domain | Month 18 | -5.9 units on a scale | Standard Deviation 36.65 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Constipation Domain | Month 3 | 0.0 units on a scale | Standard Deviation 37.02 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Constipation Domain | Month 6 | -5.1 units on a scale | Standard Deviation 37.39 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Constipation Domain | Month 3 | 13.9 units on a scale | Standard Deviation 39.3 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Constipation Domain | Month 6 | 6.8 units on a scale | Standard Deviation 40.41 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Constipation Domain | Discontinuation Visit | -2.2 units on a scale | Standard Deviation 38.86 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Constipation Domain | Month 12 | 3.7 units on a scale | Standard Deviation 38.28 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Constipation Domain | Month 1 | 18.4 units on a scale | Standard Deviation 41.23 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Constipation Domain | Month 18 | 0.0 units on a scale | Standard Deviation 37.06 |
Secondary
Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Diarrhea Scale is scored between 0 and 100, with a high score indicating a higher level of diarrhea. Negative change from Baseline values indicate improvement in diarrhea and positive values indicate worsening of diarrhea.
Time frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Population: ITT population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | Month 1 | 3.8 units on a scale | Standard Deviation 25.53 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | Month 3 | 3.7 units on a scale | Standard Deviation 24.99 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | Month 6 | 8.2 units on a scale | Standard Deviation 28.36 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | Month 12 | 11.8 units on a scale | Standard Deviation 31.35 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | Month 18 | 14.8 units on a scale | Standard Deviation 31.2 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | Discontinuation Visit | 10.8 units on a scale | Standard Deviation 29.56 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | Discontinuation Visit | 6.4 units on a scale | Standard Deviation 31.38 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | Month 1 | 2.3 units on a scale | Standard Deviation 24.94 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | Month 12 | 9.1 units on a scale | Standard Deviation 28.74 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | Month 18 | 10.9 units on a scale | Standard Deviation 30.96 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | Month 3 | 3.4 units on a scale | Standard Deviation 27.27 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | Month 6 | 6.0 units on a scale | Standard Deviation 27.95 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | Month 3 | -2.4 units on a scale | Standard Deviation 18.61 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | Month 6 | -2.2 units on a scale | Standard Deviation 21.19 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | Discontinuation Visit | -0.5 units on a scale | Standard Deviation 19.39 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | Month 12 | -2.5 units on a scale | Standard Deviation 17.26 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | Month 1 | -0.6 units on a scale | Standard Deviation 18.79 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain | Month 18 | -1.7 units on a scale | Standard Deviation 17.46 |
Secondary
Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
Time frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Population: ITT population includes all participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | Month 1 | 0.9 units on a scale | Standard Deviation 30.87 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | Month 3 | -0.8 units on a scale | Standard Deviation 31.87 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | Month 6 | -2.3 units on a scale | Standard Deviation 33.12 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | Month 12 | -3.5 units on a scale | Standard Deviation 30.97 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | Month 18 | -1.8 units on a scale | Standard Deviation 32.73 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | Discontinuation Visit | -1.0 units on a scale | Standard Deviation 37.42 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | Discontinuation Visit | 0.8 units on a scale | Standard Deviation 31.01 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | Month 1 | 3.6 units on a scale | Standard Deviation 29.85 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | Month 12 | -1.6 units on a scale | Standard Deviation 29.23 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | Month 18 | 2.9 units on a scale | Standard Deviation 28.33 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | Month 3 | -1.9 units on a scale | Standard Deviation 29.45 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | Month 6 | -2.9 units on a scale | Standard Deviation 29.66 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | Month 3 | 2.0 units on a scale | Standard Deviation 32.49 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | Month 6 | 0.1 units on a scale | Standard Deviation 30.29 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | Discontinuation Visit | 7.8 units on a scale | Standard Deviation 33.72 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | Month 12 | -1.6 units on a scale | Standard Deviation 32.76 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | Month 1 | 4.2 units on a scale | Standard Deviation 32.04 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain | Month 18 | 0.4 units on a scale | Standard Deviation 32.68 |
Secondary
Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Time frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Population: Intent to Treat (ITT) population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | Month 1 | 0.6 units on a scale | Standard Deviation 22.13 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | Month 3 | 3.8 units on a scale | Standard Deviation 22.29 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | Month 6 | 4.6 units on a scale | Standard Deviation 24.36 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | Month 12 | 4.6 units on a scale | Standard Deviation 24.08 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | Month 18 | 5.8 units on a scale | Standard Deviation 25.61 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | Discontinuation Visit | 2.6 units on a scale | Standard Deviation 24.3 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | Discontinuation Visit | 3.7 units on a scale | Standard Deviation 23.77 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | Month 1 | 0.1 units on a scale | Standard Deviation 20.73 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | Month 12 | 4.9 units on a scale | Standard Deviation 22.23 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | Month 18 | 3.1 units on a scale | Standard Deviation 23.31 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | Month 3 | 3.9 units on a scale | Standard Deviation 22.11 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | Month 6 | 5.8 units on a scale | Standard Deviation 22.39 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | Month 3 | 2.1 units on a scale | Standard Deviation 22.27 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | Month 6 | 5.5 units on a scale | Standard Deviation 22.55 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | Discontinuation Visit | -0.0 units on a scale | Standard Deviation 24.72 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | Month 12 | 5.1 units on a scale | Standard Deviation 22.37 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | Month 1 | 1.0 units on a scale | Standard Deviation 21.52 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain | Month 18 | 5.1 units on a scale | Standard Deviation 22.99 |
Secondary
Change From Baseline in the EORTC QLQ-C30 Fatigue Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
Time frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation
Population: Intent to Treat (ITT) population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | Month 1 | 2.6 units on a scale | Standard Deviation 25.32 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | Month 3 | -2.5 units on a scale | Standard Deviation 28.15 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | Month 6 | -3.7 units on a scale | Standard Deviation 28.54 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | Month 12 | -4.3 units on a scale | Standard Deviation 29.47 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | Month 18 | -3.1 units on a scale | Standard Deviation 29.82 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | Discontinuation Visit | 0.3 units on a scale | Standard Deviation 29.75 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | Discontinuation Visit | -1.6 units on a scale | Standard Deviation 29.11 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | Month 1 | 4.4 units on a scale | Standard Deviation 24.03 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | Month 12 | -2.3 units on a scale | Standard Deviation 26.63 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | Month 18 | 0.1 units on a scale | Standard Deviation 29.12 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | Month 3 | -3.4 units on a scale | Standard Deviation 25.16 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | Month 6 | -5.9 units on a scale | Standard Deviation 26.37 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | Month 3 | -1.8 units on a scale | Standard Deviation 28.53 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | Month 6 | -4.5 units on a scale | Standard Deviation 29.09 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | Discontinuation Visit | 2.7 units on a scale | Standard Deviation 30.15 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | Month 12 | -3.9 units on a scale | Standard Deviation 29.56 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | Month 1 | 2.8 units on a scale | Standard Deviation 25.44 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain | Month 18 | -4.3 units on a scale | Standard Deviation 30.05 |
Secondary
Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Difficulties Scale is scored between 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicate improvement in financial difficulties and positive values indicate worsening of financial difficulties.
Time frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Population: ITT population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | Discontinuation Visit | 1.9 units on a scale | Standard Deviation 27.19 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | Month 6 | 1.4 units on a scale | Standard Deviation 22.92 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | Month 1 | 2.1 units on a scale | Standard Deviation 21.43 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | Month 18 | 2.0 units on a scale | Standard Deviation 22.23 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | Month 12 | 0.4 units on a scale | Standard Deviation 23.99 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | Month 3 | 1.9 units on a scale | Standard Deviation 23.09 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | Month 3 | -0.4 units on a scale | Standard Deviation 21.88 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | Month 12 | 1.6 units on a scale | Standard Deviation 23.28 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | Month 18 | 1.8 units on a scale | Standard Deviation 23.3 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | Discontinuation Visit | 0.5 units on a scale | Standard Deviation 23.84 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | Month 1 | -0.3 units on a scale | Standard Deviation 20.59 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | Month 6 | -0.3 units on a scale | Standard Deviation 21.24 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | Month 1 | 0.5 units on a scale | Standard Deviation 22.98 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | Month 18 | 0.4 units on a scale | Standard Deviation 21.2 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | Month 3 | 1.9 units on a scale | Standard Deviation 21.48 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | Month 12 | 1.1 units on a scale | Standard Deviation 23.16 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | Discontinuation Visit | 5.0 units on a scale | Standard Deviation 24.82 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain | Month 6 | 0.7 units on a scale | Standard Deviation 24.57 |
Secondary
Change From Baseline in the EORTC QLQ-C30 Insomnia Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
Time frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Population: Intent to Treat (ITT) population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | Month 18 | -0.5 units on a scale | Standard Deviation 37.11 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | Month 6 | -1.2 units on a scale | Standard Deviation 34.84 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | Discontinuation Visit | -5.2 units on a scale | Standard Deviation 36.47 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | Month 1 | 2.1 units on a scale | Standard Deviation 33.34 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | Month 12 | -1.0 units on a scale | Standard Deviation 34.78 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | Month 3 | 0.2 units on a scale | Standard Deviation 35.11 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | Month 12 | 1.1 units on a scale | Standard Deviation 32.47 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | Month 3 | -1.3 units on a scale | Standard Deviation 33.54 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | Discontinuation Visit | -1.6 units on a scale | Standard Deviation 31.27 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | Month 18 | 1.4 units on a scale | Standard Deviation 35.72 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | Month 1 | 3.2 units on a scale | Standard Deviation 34.32 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | Month 6 | -1.9 units on a scale | Standard Deviation 31.43 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | Discontinuation Visit | -4.5 units on a scale | Standard Deviation 36.98 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | Month 1 | -10.5 units on a scale | Standard Deviation 30.47 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | Month 3 | -8.9 units on a scale | Standard Deviation 35.28 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | Month 6 | -11.6 units on a scale | Standard Deviation 32.96 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | Month 12 | -9.6 units on a scale | Standard Deviation 31 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain | Month 18 | -6.0 units on a scale | Standard Deviation 34.42 |
Secondary
Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea/Vomiting Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
Time frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Population: Intent to Treat (ITT) population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | Month 1 | 1.8 units on a scale | Standard Deviation 20.05 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | Month 3 | -1.1 units on a scale | Standard Deviation 19.42 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | Month 6 | -1.3 units on a scale | Standard Deviation 18.53 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | Month 12 | -2.2 units on a scale | Standard Deviation 17.16 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | Month 18 | -2.3 units on a scale | Standard Deviation 19.2 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | Discontinuation Visit | 0.4 units on a scale | Standard Deviation 21.43 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | Discontinuation Visit | -4.2 units on a scale | Standard Deviation 24.37 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | Month 1 | -0.5 units on a scale | Standard Deviation 23.19 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | Month 12 | -3.6 units on a scale | Standard Deviation 18.86 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | Month 18 | -2.7 units on a scale | Standard Deviation 18.92 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | Month 3 | -2.5 units on a scale | Standard Deviation 21.92 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | Month 6 | -4.0 units on a scale | Standard Deviation 21.52 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | Month 3 | -1.2 units on a scale | Standard Deviation 19.89 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | Month 6 | -3.9 units on a scale | Standard Deviation 19.57 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | Discontinuation Visit | 1.0 units on a scale | Standard Deviation 21.46 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | Month 12 | -3.9 units on a scale | Standard Deviation 19.09 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | Month 1 | 4.0 units on a scale | Standard Deviation 22.91 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain | Month 18 | -3.9 units on a scale | Standard Deviation 19.44 |
Secondary
Change From Baseline in the EORTC QLQ-C30 Pain Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
Time frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Population: Intent to Treat (ITT) population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Pain Domain | Month 18 | -14.4 units on a scale | Standard Deviation 35.03 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Pain Domain | Month 6 | -14.4 units on a scale | Standard Deviation 35.64 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Pain Domain | Discontinuation Visit | -8.0 units on a scale | Standard Deviation 39.37 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Pain Domain | Month 1 | -5.4 units on a scale | Standard Deviation 31.89 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Pain Domain | Month 12 | -14.0 units on a scale | Standard Deviation 36.05 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Pain Domain | Month 3 | -13.4 units on a scale | Standard Deviation 34.28 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Pain Domain | Month 12 | -14.7 units on a scale | Standard Deviation 32.34 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Pain Domain | Month 3 | -13.1 units on a scale | Standard Deviation 32.32 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Pain Domain | Discontinuation Visit | -7.9 units on a scale | Standard Deviation 37.65 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Pain Domain | Month 18 | -12.4 units on a scale | Standard Deviation 35.28 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Pain Domain | Month 1 | -4.4 units on a scale | Standard Deviation 30.7 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Pain Domain | Month 6 | -16.1 units on a scale | Standard Deviation 33.44 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Pain Domain | Discontinuation Visit | -6.0 units on a scale | Standard Deviation 37.09 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Pain Domain | Month 1 | -7.8 units on a scale | Standard Deviation 30.93 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Pain Domain | Month 3 | -12.1 units on a scale | Standard Deviation 31.98 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Pain Domain | Month 6 | -13.4 units on a scale | Standard Deviation 34.45 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Pain Domain | Month 12 | -14.3 units on a scale | Standard Deviation 32.85 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Pain Domain | Month 18 | -14.7 units on a scale | Standard Deviation 32.81 |
Secondary
Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Time frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Population: Intent to Treat (ITT) population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | Month 1 | -1.7 units on a scale | Standard Deviation 21.11 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | Month 3 | 3.4 units on a scale | Standard Deviation 23.33 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | Month 6 | 4.7 units on a scale | Standard Deviation 25.09 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | Month 12 | 5.0 units on a scale | Standard Deviation 25.65 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | Month 18 | 6.9 units on a scale | Standard Deviation 26.71 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | Discontinuation Visit | -0.1 units on a scale | Standard Deviation 29.7 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | Discontinuation Visit | 3.0 units on a scale | Standard Deviation 27.32 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | Month 1 | -1.4 units on a scale | Standard Deviation 19.56 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | Month 12 | 7.4 units on a scale | Standard Deviation 23.4 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | Month 18 | 6.8 units on a scale | Standard Deviation 23.58 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | Month 3 | 4.7 units on a scale | Standard Deviation 22.94 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | Month 6 | 7.6 units on a scale | Standard Deviation 22.85 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | Month 3 | 2.2 units on a scale | Standard Deviation 23.68 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | Month 6 | 5.3 units on a scale | Standard Deviation 24.52 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | Discontinuation Visit | -0.1 units on a scale | Standard Deviation 27.58 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | Month 12 | 6.9 units on a scale | Standard Deviation 27.22 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | Month 1 | -0.9 units on a scale | Standard Deviation 21.28 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain | Month 18 | 8.3 units on a scale | Standard Deviation 27.1 |
Secondary
Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Time frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Population: Intent to Treat (ITT) population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | Month 1 | -2.7 units on a scale | Standard Deviation 29.94 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | Month 3 | 2.4 units on a scale | Standard Deviation 33.32 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | Month 6 | 6.3 units on a scale | Standard Deviation 35.44 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | Month 12 | 7.8 units on a scale | Standard Deviation 36.6 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | Month 18 | 8.0 units on a scale | Standard Deviation 35.34 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | Discontinuation Visit | -0.3 units on a scale | Standard Deviation 39.58 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | Discontinuation Visit | 3.8 units on a scale | Standard Deviation 36.34 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | Month 1 | -4.6 units on a scale | Standard Deviation 28.2 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | Month 12 | 9.4 units on a scale | Standard Deviation 34.15 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | Month 18 | 9.1 units on a scale | Standard Deviation 34.35 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | Month 3 | 6.3 units on a scale | Standard Deviation 32.43 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | Month 6 | 8.6 units on a scale | Standard Deviation 32.42 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | Month 3 | 4.1 units on a scale | Standard Deviation 34.23 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | Month 6 | 8.2 units on a scale | Standard Deviation 36.09 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | Discontinuation Visit | -1.0 units on a scale | Standard Deviation 38.41 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | Month 12 | 11.8 units on a scale | Standard Deviation 38.94 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | Month 1 | -2.4 units on a scale | Standard Deviation 30.48 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain | Month 18 | 14.5 units on a scale | Standard Deviation 39.03 |
Secondary
Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
Time frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Population: Intent to Treat (ITT) population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | Month 1 | -4.3 units on a scale | Standard Deviation 29.1 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | Month 3 | 0.7 units on a scale | Standard Deviation 29.36 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | Month 6 | 4.0 units on a scale | Standard Deviation 32.48 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | Month 12 | 2.9 units on a scale | Standard Deviation 34.96 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | Month 18 | 4.2 units on a scale | Standard Deviation 34.99 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | Discontinuation Visit | -1.2 units on a scale | Standard Deviation 33.5 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | Discontinuation Visit | 2.7 units on a scale | Standard Deviation 33.37 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | Month 1 | -2.2 units on a scale | Standard Deviation 27.44 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | Month 12 | 3.8 units on a scale | Standard Deviation 32.29 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | Month 18 | 3.2 units on a scale | Standard Deviation 31.67 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | Month 3 | 2.0 units on a scale | Standard Deviation 30.93 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | Month 6 | 5.2 units on a scale | Standard Deviation 28.5 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | Month 3 | 2.4 units on a scale | Standard Deviation 30.7 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | Month 6 | 3.4 units on a scale | Standard Deviation 35.24 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | Discontinuation Visit | -3.5 units on a scale | Standard Deviation 33.2 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | Month 12 | 5.8 units on a scale | Standard Deviation 33.68 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | Month 1 | -1.4 units on a scale | Standard Deviation 30.52 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain | Month 18 | 6.0 units on a scale | Standard Deviation 35.2 |
Secondary
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement.
Time frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Population: Intent to Treat (ITT) population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | Month 3 | 4.8 units on a scale | Standard Deviation 24.15 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | Month 1 | 0.4 units on a scale | Standard Deviation 23.98 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | Month 6 | 5.9 units on a scale | Standard Deviation 25.93 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | Study discontinuation | -0.1 units on a scale | Standard Deviation 27.07 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | Month 12 | 4.8 units on a scale | Standard Deviation 26.42 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | Month 18 | 6.4 units on a scale | Standard Deviation 28.02 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | Month 12 | 3.2 units on a scale | Standard Deviation 25.38 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | Month 18 | 5.7 units on a scale | Standard Deviation 24.86 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | Study discontinuation | 5.0 units on a scale | Standard Deviation 27.33 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | Month 6 | 5.4 units on a scale | Standard Deviation 23.88 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | Month 3 | 4.7 units on a scale | Standard Deviation 25.15 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | Month 1 | -1.3 units on a scale | Standard Deviation 23.93 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | Study discontinuation | 0.3 units on a scale | Standard Deviation 28.07 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | Month 1 | 1.0 units on a scale | Standard Deviation 23.68 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | Month 3 | 4.3 units on a scale | Standard Deviation 26.04 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | Month 6 | 6.1 units on a scale | Standard Deviation 25.98 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | Month 12 | 6.5 units on a scale | Standard Deviation 25.9 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain | Month 18 | 4.8 units on a scale | Standard Deviation 27.05 |
Secondary
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the body image scale, a higher score indicates a better body image.
Time frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Population: ITT population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | Month 18 | -2.3 units on a scale | Standard Deviation 28.09 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | Month 6 | -1.4 units on a scale | Standard Deviation 27.84 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | Discontinuation Visit | -5.6 units on a scale | Standard Deviation 34.29 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | Month 1 | -4.5 units on a scale | Standard Deviation 29.44 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | Month 12 | -1.4 units on a scale | Standard Deviation 29.6 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | Month 3 | -1.7 units on a scale | Standard Deviation 27.54 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | Month 12 | -0.4 units on a scale | Standard Deviation 31.64 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | Month 3 | 0.8 units on a scale | Standard Deviation 26.23 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | Discontinuation Visit | 1.8 units on a scale | Standard Deviation 30.66 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | Month 18 | -0.3 units on a scale | Standard Deviation 31.04 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | Month 1 | -1.5 units on a scale | Standard Deviation 27.19 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | Month 6 | 1.5 units on a scale | Standard Deviation 29.72 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | Discontinuation Visit | -5.6 units on a scale | Standard Deviation 33.73 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | Month 1 | -1.6 units on a scale | Standard Deviation 29.97 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | Month 3 | -3.0 units on a scale | Standard Deviation 29.38 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | Month 6 | -2.8 units on a scale | Standard Deviation 33.07 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | Month 12 | -2.6 units on a scale | Standard Deviation 31.96 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale | Month 18 | -1.1 units on a scale | Standard Deviation 33.6 |
Secondary
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score indicates more severe disease symptom(s).
Time frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Population: ITT population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Month 1 | -4.0 units on a scale | Standard Deviation 18.75 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Month 3 | -9.1 units on a scale | Standard Deviation 21.66 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Month 6 | -8.8 units on a scale | Standard Deviation 20.89 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Month 12 | -7.8 units on a scale | Standard Deviation 21.74 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Month 18 | -8.7 units on a scale | Standard Deviation 23.5 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Discontinuation Visit | -3.5 units on a scale | Standard Deviation 24.82 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Discontinuation Visit | -4.5 units on a scale | Standard Deviation 24.9 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Month 1 | -4.1 units on a scale | Standard Deviation 19.37 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Month 12 | -8.7 units on a scale | Standard Deviation 20.29 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Month 18 | -6.2 units on a scale | Standard Deviation 23.3 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Month 3 | -10.0 units on a scale | Standard Deviation 19.97 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Month 6 | -9.9 units on a scale | Standard Deviation 20.94 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Month 3 | -7.0 units on a scale | Standard Deviation 20.43 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Month 6 | -7.9 units on a scale | Standard Deviation 21.94 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Discontinuation Visit | -3.7 units on a scale | Standard Deviation 23.54 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Month 12 | -6.5 units on a scale | Standard Deviation 21.58 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Month 1 | -4.4 units on a scale | Standard Deviation 19.04 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale | Month 18 | -7.9 units on a scale | Standard Deviation 21.26 |
Secondary
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the future perspective scale, a higher score indicates a better perspective of the future.
Time frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Population: ITT population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | Month 1 | 4.7 units on a scale | Standard Deviation 22.17 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | Month 3 | 8.5 units on a scale | Standard Deviation 23.28 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | Month 6 | 9.8 units on a scale | Standard Deviation 23.67 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | Month 12 | 10.8 units on a scale | Standard Deviation 21.9 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | Month 18 | 12.7 units on a scale | Standard Deviation 23.96 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | Discontinuation Visit | 5.8 units on a scale | Standard Deviation 25.91 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | Discontinuation Visit | 8.8 units on a scale | Standard Deviation 26.71 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | Month 1 | 3.9 units on a scale | Standard Deviation 20.94 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | Month 12 | 12.1 units on a scale | Standard Deviation 24.41 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | Month 18 | 11.7 units on a scale | Standard Deviation 24.76 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | Month 3 | 9.2 units on a scale | Standard Deviation 22.95 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | Month 6 | 12.3 units on a scale | Standard Deviation 24.84 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | Month 3 | 6.3 units on a scale | Standard Deviation 25.06 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | Month 6 | 8.0 units on a scale | Standard Deviation 25.26 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | Discontinuation Visit | 3.2 units on a scale | Standard Deviation 27.13 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | Month 12 | 10.0 units on a scale | Standard Deviation 26.3 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | Month 1 | 3.3 units on a scale | Standard Deviation 23.2 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale | Month 18 | 9.5 units on a scale | Standard Deviation 21.75 |
Secondary
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment.
Time frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Population: ITT population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | Month 1 | 2.5 units on a scale | Standard Deviation 13.72 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | Month 3 | 1.0 units on a scale | Standard Deviation 15.23 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | Month 6 | 1.7 units on a scale | Standard Deviation 15.58 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | Month 12 | 1.9 units on a scale | Standard Deviation 14.49 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | Month 18 | 2.2 units on a scale | Standard Deviation 15.63 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | Discontinuation Visit | 0.6 units on a scale | Standard Deviation 15.85 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | Discontinuation Visit | -1.0 units on a scale | Standard Deviation 15.81 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | Month 1 | 4.0 units on a scale | Standard Deviation 14.89 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | Month 12 | 1.2 units on a scale | Standard Deviation 16.2 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | Month 18 | 2.3 units on a scale | Standard Deviation 17.36 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | Month 3 | 1.2 units on a scale | Standard Deviation 14.67 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | Month 6 | -0.4 units on a scale | Standard Deviation 14.39 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | Month 3 | 3.5 units on a scale | Standard Deviation 15.4 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | Month 6 | 2.9 units on a scale | Standard Deviation 17.28 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | Discontinuation Visit | 3.8 units on a scale | Standard Deviation 16.52 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | Month 12 | 4.7 units on a scale | Standard Deviation 17.17 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | Month 1 | 5.6 units on a scale | Standard Deviation 15 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale | Month 18 | 4.3 units on a scale | Standard Deviation 16.37 |
Secondary
Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score
EQ-5D is a self-administered questionnaire that assesses health-related quality of life. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where higher EQ-5D scores represent better health status. A positive change from baseline score indicates improvement in health status and better health state.
Time frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
Population: ITT population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | Month 6 | 0.1 units on a scale | Standard Deviation 0.32 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | Month 1 | 0.0 units on a scale | Standard Deviation 0.29 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | Month 12 | 0.1 units on a scale | Standard Deviation 0.33 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | Discontinuation Visit | 0.0 units on a scale | Standard Deviation 0.4 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | Month 3 | 0.1 units on a scale | Standard Deviation 0.33 |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | Month 18 | 0.1 units on a scale | Standard Deviation 0.36 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | Month 3 | 0.1 units on a scale | Standard Deviation 0.32 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | Month 1 | -0.0 units on a scale | Standard Deviation 0.31 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | Month 6 | 0.1 units on a scale | Standard Deviation 0.31 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | Month 12 | 0.1 units on a scale | Standard Deviation 0.31 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | Month 18 | 0.1 units on a scale | Standard Deviation 0.32 |
| Lenalidomide and Dexamethasone Rd18 | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | Discontinuation Visit | 0.0 units on a scale | Standard Deviation 0.35 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | Month 3 | 0.1 units on a scale | Standard Deviation 0.32 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | Discontinuation Visit | 0.0 units on a scale | Standard Deviation 0.39 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | Month 18 | 0.1 units on a scale | Standard Deviation 0.35 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | Month 6 | 0.1 units on a scale | Standard Deviation 0.34 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | Month 1 | 0.0 units on a scale | Standard Deviation 0.28 |
| Melphalan + Prednisone + Thalidomide (MPT) | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score | Month 12 | 0.1 units on a scale | Standard Deviation 0.35 |
Secondary
Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year
HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of inpatient hospitalizations per patient year was calculated as the total number of hospitalizations divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.
Time frame: Day 1 (randomization) up to last visit completed 25 July 2016
Population: Healthcare Resource Utilization not analyzed.
Secondary
Improvement of Infection Rate by Observing the Historical Data Compared to the Clinical Data Base
Improvement of infection rate by observing historical data compared to the data within clinical database as not analyzed.
Time frame: From randomization to 24 May 2013
Secondary
Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT)
Time to second-line anti-myeloma therapy was defined as time from randomization to the start of another non-protocol anti-myeloma therapy.
Time frame: From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 23.0 months
Population: ITT population includes all participants who were randomized, independent of whether they received study treatment or not
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT) | 39.1 months |
| Lenalidomide and Dexamethasone Rd18 | Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT) | 28.5 months |
| Melphalan + Prednisone + Thalidomide (MPT) | Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT) | 26.7 months |
p-value: <0.0000195% CI: [0.56, 0.78]Log Rank
p-value: 0.0006795% CI: [0.63, 0.88]Log Rank
p-value: 0.1233395% CI: [0.75, 1.03]Log Rank
Secondary
Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis
Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first.
Time frame: Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months
Population: Study participants with at least a PR
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis | 31.5 months |
| Lenalidomide and Dexamethasone Rd18 | Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis | 21.5 months |
| Melphalan + Prednisone + Thalidomide (MPT) | Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis | 22.1 months |
p-value: <0.0000195% CI: [0.51, 0.72]Log Rank
p-value: <0.0000195% CI: [0.52, 0.72]Log Rank
p-value: 0.9953795% CI: [0.85, 1.17]Log Rank
Secondary
Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC
Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first.
Time frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months
Population: Study participants with at least a PR
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC | 35.0 months |
| Lenalidomide and Dexamethasone Rd18 | Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC | 22.1 months |
| Melphalan + Prednisone + Thalidomide (MPT) | Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC | 22.3 months |
p-value: <0.0000195% CI: [0.51, 0.76]Log Rank
p-value: <0.0000195% CI: [0.5, 0.72]Log Rank
p-value: 0.767495% CI: [0.86, 1.23]Log Rank
Secondary
Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS)
Overall survival was defined as the time between randomization and death. Participants, who died, regardless of the cause of death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the participant was known to be alive.
Time frame: From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months
Population: ITT population included all participants who were randomized, independent of whether they received study treatment or not.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS) | 59.1 months |
| Lenalidomide and Dexamethasone Rd18 | Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS) | 62.3 months |
| Melphalan + Prednisone + Thalidomide (MPT) | Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS) | 49.1 months |
p-value: 0.0023495% CI: [0.67, 0.92]Log Rank
p-value: 0.8290395% CI: [0.86, 1.2]Log Rank
p-value: 0.0011995% CI: [0.66, 0.9]Log Rank
Secondary
Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis
Time to second-line anti-myeloma therapy is defined as time from randomization to the start of another non-protocol anti-myeloma therapy. Those who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy.
Time frame: From date of randomization until the data cut-off of date 21 January 2016; median follow-up for all participants was 23.0 months
Population: ITT population includes all participants who were randomized, independent of whether they received study treatment or not.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis | 36.7 months |
| Lenalidomide and Dexamethasone Rd18 | Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis | 28.5 months |
| Melphalan + Prednisone + Thalidomide (MPT) | Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis | 26.7 months |
p-value: <0.0000195% CI: [0.54, 0.73]Log Rank
p-value: 0.0000195% CI: [0.61, 0.83]Log Rank
p-value: 0.0582195% CI: [0.76, 1]Log Rank
Secondary
Kaplan Meier Estimates of Time to Treatment Failure (TTF)
TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by IRAC based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death.
Time frame: From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 16.1 months.
Population: ITT population includes participants who were randomized, independent of whether they received study treatment or not
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Kaplan Meier Estimates of Time to Treatment Failure (TTF) | 16.9 months |
| Lenalidomide and Dexamethasone Rd18 | Kaplan Meier Estimates of Time to Treatment Failure (TTF) | 17.2 months |
| Melphalan + Prednisone + Thalidomide (MPT) | Kaplan Meier Estimates of Time to Treatment Failure (TTF) | 14.1 months |
p-value: 0.0001295% CI: [0.68, 0.88]Log Rank
p-value: 0.0018795% CI: [0.71, 0.93]Log Rank
p-value: 0.4597395% CI: [0.84, 1.08]Log Rank
Secondary
Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis
TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by the investigators assessment based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death.
Time frame: From date of randomization until the data cut-off date of 21 January 2016; median follow up for all participants was 16.1 months.
Population: ITT population includes participants who were randomized, independent of whether they received study treatment or not
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis | 16.9 months |
| Lenalidomide and Dexamethasone Rd18 | Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis | 17.2 months |
| Melphalan + Prednisone + Thalidomide (MPT) | Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis | 14.1 months |
p-value: 0.0000295% CI: [0.67, 0.86]Log Rank
p-value: 0.0012695% CI: [0.72, 0.92]Log Rank
p-value: 0.2770495% CI: [0.83, 1.06]Log Rank
Secondary
Number of Participants With Adverse Events (AEs) During the Active Treatment Phase
A TEAE is any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event.
Time frame: From first dose of study drug through 28 days following the discontinuation visit from active treatment phase; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Population: Safety population included all participants who received at least one dose treatment dose of treatment in any arm
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to prednisone withdrawal | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Grade 5 AE related to Len/Dex/Mel/Pred/Thal | 17 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 AE related to dexamethasone | 429 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to melphalan withdrawal | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Grade 5 AE related to Lenalidomide | 12 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade (Gr) 5 AE | 50 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to dexamethasone withdrawal | 152 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Grade 5 AE related to Dexamethasone | 16 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade 3 or 4 AE related to dexamethasone | 229 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Lenalidomide withdrawal | 109 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Grade 5 AE related to melphalan | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 AE related to melphalan | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1AE leading to Len/Dex/Mel/Pred/Thal Withdrawal | 157 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Grade 5 AE related to prednisone | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Len and Dex or MPT interruption | 290 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to Len/Dex or Mel/Pred/Thal | 95 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Grade 5 AE related to Thalidomide | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Rd or MPT interruption | 368 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to thalidomide | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 Grade 5 AE related to Len/Dex or Mel/Pred/Thal | 11 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 AE related to prednisone | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to prednisone | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to Len/Dex/Mel/Pred/Thal | 195 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to prednisone interruption | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to melphalan | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to Lenalidomide | 165 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1AE leading to Len/Dex or Mel/Pred/Thal reduction | 30 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to dexamethasone | 130 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 AE related to thalidomide | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 serious adverse event (SAE) | 359 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to thalidomide reduction | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE related to Lenalidomide/Dex or Mel/Pred/Thal | 269 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade (Gr) 3 or 4 AE | 453 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to prednisone reduction | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Gr 3 or 4 AE related to Len/Dex/Mel/Pred/Thal | 373 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to melphalan interruption | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to melphalan reduction | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade 3 or 4 AE related to Lenalidomide | 342 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 AE related to Lenalidomide/Dex/Mel/Pred/Thal | 506 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to dexamethasone reduction | 170 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 adverse event (AE) | 529 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Lenalidomide reduction | 203 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade 3 or 4 AE related to melphalan | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to dexamethasone interruption | 319 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1AE leading to Len/Dex/Mel/Pred/Thal reduction | 279 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade 3 or 4 AE related to prednisone | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 AE related to Lenalidomide | 482 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1AE leading to Len/DexOR Mel/Pred/Thal Withdrawal | 96 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade 3 or 4 AE related to Thalidomide | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Thalidomide interruption | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Thalidomide withdrawal | 0 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1Gr 3 or 4 AE related to Len/Dex or Mel/Pred/Thal | 131 Participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Lenalidomide interruption | 353 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Rd or MPT interruption | 321 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 adverse event (AE) | 536 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade (Gr) 3 or 4 AE | 433 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade (Gr) 5 AE | 36 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 serious adverse event (SAE) | 308 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 AE related to Lenalidomide/Dex/Mel/Pred/Thal | 501 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 AE related to Lenalidomide | 481 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 AE related to dexamethasone | 410 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 AE related to melphalan | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 AE related to prednisone | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 AE related to thalidomide | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE related to Lenalidomide/Dex or Mel/Pred/Thal | 269 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Gr 3 or 4 AE related to Len/Dex/Mel/Pred/Thal | 326 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade 3 or 4 AE related to Lenalidomide | 290 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade 3 or 4 AE related to dexamethasone | 177 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade 3 or 4 AE related to melphalan | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade 3 or 4 AE related to prednisone | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade 3 or 4 AE related to Thalidomide | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1Gr 3 or 4 AE related to Len/Dex or Mel/Pred/Thal | 104 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Grade 5 AE related to Len/Dex/Mel/Pred/Thal | 11 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Grade 5 AE related to Lenalidomide | 9 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Grade 5 AE related to Dexamethasone | 7 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Grade 5 AE related to melphalan | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Grade 5 AE related to prednisone | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Grade 5 AE related to Thalidomide | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 Grade 5 AE related to Len/Dex or Mel/Pred/Thal | 5 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to Len/Dex/Mel/Pred/Thal | 158 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to Lenalidomide | 130 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to dexamethasone | 97 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to melphalan | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to prednisone | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to thalidomide | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to Len/Dex or Mel/Pred/Thal | 64 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1AE leading to Len/Dex/Mel/Pred/Thal Withdrawal | 109 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Lenalidomide withdrawal | 93 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to dexamethasone withdrawal | 104 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to melphalan withdrawal | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to prednisone withdrawal | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Thalidomide withdrawal | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1AE leading to Len/DexOR Mel/Pred/Thal Withdrawal | 84 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1AE leading to Len/Dex/Mel/Pred/Thal reduction | 214 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Lenalidomide reduction | 155 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to dexamethasone reduction | 118 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to melphalan reduction | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to prednisone reduction | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to thalidomide reduction | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1AE leading to Len/Dex or Mel/Pred/Thal reduction | 20 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Lenalidomide interruption | 301 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to dexamethasone interruption | 280 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to melphalan interruption | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to prednisone interruption | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Thalidomide interruption | 0 Participants |
| Lenalidomide and Dexamethasone Rd18 | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Len and Dex or MPT interruption | 241 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade (Gr) 3 or 4 AE | 480 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to melphalan withdrawal | 83 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1Gr 3 or 4 AE related to Len/Dex or Mel/Pred/Thal | 49 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Lenalidomide interruption | 0 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to prednisone withdrawal | 78 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade 3 or 4 AE related to Thalidomide | 316 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 AE related to Lenalidomide/Dex/Mel/Pred/Thal | 527 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Thalidomide withdrawal | 146 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade 3 or 4 AE related to prednisone | 118 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Len and Dex or MPT interruption | 249 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1AE leading to Len/DexOR Mel/Pred/Thal Withdrawal | 71 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade 3 or 4 AE related to melphalan | 307 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to dexamethasone interruption | 0 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1AE leading to Len/Dex/Mel/Pred/Thal reduction | 348 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade 3 or 4 AE related to dexamethasone | 0 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 serious adverse event (SAE) | 270 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Lenalidomide reduction | 0 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade 3 or 4 AE related to Lenalidomide | 0 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Thalidomide interruption | 388 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to dexamethasone reduction | 0 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Gr 3 or 4 AE related to Len/Dex/Mel/Pred/Thal | 423 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to melphalan interruption | 328 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to melphalan reduction | 199 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE related to Lenalidomide/Dex or Mel/Pred/Thal | 145 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 grade (Gr) 5 AE | 38 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to prednisone reduction | 47 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 AE related to thalidomide | 493 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 adverse event (AE) | 539 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to Lenalidomide | 0 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to thalidomide reduction | 254 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to dexamethasone | 0 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to Len/Dex/Mel/Pred/Thal | 142 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 AE related to prednisone | 326 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to melphalan | 75 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 Grade 5 AE related to Len/Dex or Mel/Pred/Thal | 2 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to prednisone interruption | 324 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to prednisone | 62 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Grade 5 AE related to Thalidomide | 5 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1AE leading to Len/Dex or Mel/Pred/Thal reduction | 2 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to thalidomide | 94 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Grade 5 AE related to prednisone | 5 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 AE related to melphalan | 441 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 SAE related to Len/Dex or Mel/Pred/Thal | 27 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Grade 5 AE related to melphalan | 6 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 AE related to dexamethasone | 0 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1AE leading to Len/Dex/Mel/Pred/Thal Withdrawal | 153 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Grade 5 AE related to Dexamethasone | 0 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Rd or MPT interruption | 419 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to Lenalidomide withdrawal | 0 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Grade 5 AE related to Lenalidomide | 0 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 AE related to Lenalidomide | 0 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥1 AE leading to dexamethasone withdrawal | 0 Participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase | ≥ 1 Grade 5 AE related to Len/Dex/Mel/Pred/Thal | 10 Participants |
Secondary
Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review.
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Time frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Population: ITT population with Cytogenetic risk of Adverse Risk
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review. | 70.0 Percentage of participants |
| Lenalidomide and Dexamethasone Rd18 | Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review. | 69.7 Percentage of participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review. | 58.2 Percentage of participants |
p-value: 0.0213495% CI: [1.08, 2.59]Fisher Exact
p-value: 195% CI: [0.64, 1.59]Fisher Exact
p-value: 0.0237495% CI: [1.08, 2.53]Fisher Exact
Secondary
Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Time frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Population: ITT population with a Cytogenetic Risk of Favorable Hyperploidy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review | 80.4 percentage of participants |
| Lenalidomide and Dexamethasone Rd18 | Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review | 81.6 percentage of participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review | 70.6 percentage of participants |
p-value: 0.1115295% CI: [0.91, 3.21]Fisher Exact
p-value: 0.8633695% CI: [0.47, 1.83]Fisher Exact
p-value: 0.0732195% CI: [0.96, 3.55]Fisher Exact
Secondary
Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Time frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Population: ITT population with a cytogenetic risk of normal
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review | 80.4 percentage of particpants |
| Lenalidomide and Dexamethasone Rd18 | Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review | 74.8 percentage of particpants |
| Melphalan + Prednisone + Thalidomide (MPT) | Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review | 61.0 percentage of particpants |
p-value: 0.0004395% CI: [1.55, 4.45]Fisher Exact
p-value: 0.3127495% CI: [0.78, 2.43]Fisher Exact
p-value: 0.0193695% CI: [1.13, 3.19]Fisher Exact
Secondary
Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Time frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Population: ITT population with a Cytogenetic Risk of Uncertain Risk
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review | 60.5 percentage of participants |
| Lenalidomide and Dexamethasone Rd18 | Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review | 76.8 percentage of participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review | 57.5 percentage of participants |
p-value: 0.8212895% CI: [0.46, 2.8]Fisher Exact
p-value: 0.1104195% CI: [0.19, 1.14]Fisher Exact
p-value: 0.0730295% CI: [1.01, 5.91]Fisher Exact
Secondary
Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Time frame: Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Population: ITT population; Participants with second line AMT.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis | 46.2 percentage of participants |
| Lenalidomide and Dexamethasone Rd18 | Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis | 53.1 percentage of participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis | 45.7 percentage of participants |
p-value: 0.9382495% CI: [0.75, 1.38]Fisher Exact
p-value: 0.0883695% CI: [0.56, 1.03]Fisher Exact
p-value: 0.0497495% CI: [1.01, 1.79]Fisher Exact
Secondary
Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Time frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Population: ITT population includes all participants who were randomized, independent of whether they received study treatment or not.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis | 80.7 percentage of participants |
| Lenalidomide and Dexamethasone Rd18 | Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis | 78.6 percentage of participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis | 67.5 percentage of participants |
p-value: <0.0000195% CI: [1.53, 2.68]Fisher Exact
p-value: 0.40595% CI: [0.85, 1.54]Fisher Exact
p-value: 0.0000495% CI: [1.35, 2.32]Fisher Exact
Secondary
Percentage of Participants With an Objective Response Based on IRAC Review
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined as: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
Time frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Population: ITT population includes all participants who were randomized, independent of whether they received study treatment or not.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Percentage of Participants With an Objective Response Based on IRAC Review | 75.1 percentage of participants |
| Lenalidomide and Dexamethasone Rd18 | Percentage of Participants With an Objective Response Based on IRAC Review | 73.4 percentage of participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Percentage of Participants With an Objective Response Based on IRAC Review | 62.3 percentage of participants |
p-value: <0.0000195% CI: [1.41, 2.37]Fisher Exact
p-value: 0.5306595% CI: [0.83, 1.44]Fisher Exact
p-value: 0.000195% CI: [1.29, 2.15]Fisher Exact
Secondary
Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase
Neutrophil counts was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.
Time frame: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Population: Safety Population; includes participants with baseline and postbaseline absolute neutrophil laboratory test grade information
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Normal Baseline Grade to Grade 3 postbaseline | 70 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 3 Baseline to Grade 1 postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 1 Baseline to Grade 4 postbaseline | 9 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 4 Baseline to Grade 4 postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Normal Baseline Grade to Normal Postbaseline Grade | 103 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 2 Baseline to normal postbaseline | 1 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 4 Baseline to Grade 1 postbaseline Grade | 1 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 3 Baseline to Normal postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 2 Baseline to Grade 1 postbaseline | 1 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Normal Baseline Grade to Grade 4 postbaseline | 21 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 2 Baseline to Grade 4 postbaseline | 9 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 2 Baseline to Grade 2 postbaseline | 14 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 4 Baseline Grade to Grade 3 postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 2 Baseline to Grade 3 postbaseline | 18 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 4 Baseline to Normal postbaseline Grade | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 1 Baseline to Normal postbaseline | 7 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Normal Baseline Grade to Grade 2 postbaseline | 121 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade3 Baseline to Grade 4 postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade1 Baseline to Grade 1 postbaseline | 8 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Normal Baseline Grade to Grade 1 postbaseline | 96 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 3 Baseline to Grade 3 postbaseline | 2 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 1 Baseline to Grade 2 postbaseline | 17 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 4 Baseline to Grade 2 postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 3 Baseline to Grade 2 postbaseline | 2 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 1 Baseline to Grade 3 postbaseline | 25 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 3 Baseline to Normal postbaseline | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Normal Baseline Grade to Normal Postbaseline Grade | 133 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Normal Baseline Grade to Grade 1 postbaseline | 85 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Normal Baseline Grade to Grade 2 postbaseline | 109 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Normal Baseline Grade to Grade 3 postbaseline | 71 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Normal Baseline Grade to Grade 4 postbaseline | 30 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 1 Baseline to Normal postbaseline | 6 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade1 Baseline to Grade 1 postbaseline | 11 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 1 Baseline to Grade 2 postbaseline | 15 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 1 Baseline to Grade 3 postbaseline | 30 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 1 Baseline to Grade 4 postbaseline | 4 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 2 Baseline to normal postbaseline | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 2 Baseline to Grade 1 postbaseline | 1 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 2 Baseline to Grade 2 postbaseline | 11 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 2 Baseline to Grade 3 postbaseline | 18 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 2 Baseline to Grade 4 postbaseline | 5 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 3 Baseline to Grade 1 postbaseline | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 3 Baseline to Grade 2 postbaseline | 1 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 3 Baseline to Grade 3 postbaseline | 2 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade3 Baseline to Grade 4 postbaseline | 2 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 4 Baseline to Normal postbaseline Grade | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 4 Baseline to Grade 1 postbaseline Grade | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 4 Baseline to Grade 2 postbaseline | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 4 Baseline Grade to Grade 3 postbaseline | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 4 Baseline to Grade 4 postbaseline | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 3 Baseline to Grade 1 postbaseline | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 1 Baseline to Grade 2 postbaseline | 11 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Normal Baseline Grade to Normal Postbaseline Grade | 37 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 3 Baseline to Grade 2 postbaseline | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade1 Baseline to Grade 1 postbaseline | 2 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 4 Baseline to Grade 2 postbaseline | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 3 Baseline to Grade 3 postbaseline | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 1 Baseline to Normal postbaseline | 2 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Normal Baseline Grade to Grade 1 postbaseline | 79 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade3 Baseline to Grade 4 postbaseline | 1 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Normal Baseline Grade to Grade 4 postbaseline | 45 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 4 Baseline to Grade 4 postbaseline | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 4 Baseline to Normal postbaseline Grade | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Normal Baseline Grade to Grade 3 postbaseline | 141 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 2 Baseline to Grade 2 postbaseline | 7 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 4 Baseline Grade to Grade 3 postbaseline | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 2 Baseline to Grade 3 postbaseline | 21 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 2 Baseline to Grade 1 postbaseline | 1 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 4 Baseline to Grade 1 postbaseline Grade | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 2 Baseline to Grade 4 postbaseline | 10 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 2 Baseline to normal postbaseline | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 1 Baseline to Grade 4 postbaseline | 21 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 3 Baseline to Normal postbaseline | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Grade 1 Baseline to Grade 3 postbaseline | 20 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase | Normal Baseline Grade to Grade 2 postbaseline | 128 participants |
Secondary
Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase
Renal function was assessed for participants from baseline to the most extreme value in creatinine clearance calculated using the Cockcroft-Gault estimation.
Time frame: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Population: Safety Population with baseline and postbaseline CrCl data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl≥ 30 but < 50 mL/min to < 30 mL/min | 1 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl < 30 mL/min to CrCl ≥ 30 but < 50 mL/min | 18 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl < 30 mL/min to CrCl ≥ 50 but < 80 mL/min | 7 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl< 30 mL/min to ≥ 80 mL/min | 2 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl< 30 mL/min to CrCl< 30 mL/min | 15 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 30 but < 50 mL/min to CrCl ≥ 30 but < 50 mL | 37 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 30 but < 50 mL/min to CrCl ≥ 50 but < 80 mL | 67 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 30 but < 50 mL/min to ≥ 80 mL/min | 9 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 50 but < 80 mL to CrCl< 30 mL/min | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 50 but < 80 mL to CrCl ≥ 30 but < 50 mL/min | 4 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 50 but < 80 mL to CrCl ≥ 50 but < 80 mL/min | 112 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 50 but < 80 mL to ≥ 80 mL/min | 107 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 80 mL/min to CrCl< 30 mL/min | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 80 mL/min to CrCl ≥ 30 but < 50 mL/min | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 80 mL/min to CrCl ≥ 50 but < 80 mL/min | 6 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 80 mL/min to CrCl ≥ 80 mL/min | 109 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 30 but < 50 mL/min to CrCl ≥ 30 but < 50 mL | 41 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 30 but < 50 mL/min to CrCl ≥ 50 but < 80 mL | 55 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 30 but < 50 mL/min to ≥ 80 mL/min | 12 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 80 mL/min to CrCl ≥ 30 but < 50 mL/min | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 50 but < 80 mL to CrCl< 30 mL/min | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 50 but < 80 mL to CrCl ≥ 30 but < 50 mL/min | 1 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 80 mL/min to CrCl ≥ 80 mL/min | 114 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 50 but < 80 mL to CrCl ≥ 50 but < 80 mL/min | 130 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl< 30 mL/min to CrCl< 30 mL/min | 17 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 80 mL/min to CrCl ≥ 50 but < 80 mL/min | 10 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl < 30 mL/min to CrCl ≥ 30 but < 50 mL/min | 14 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 50 but < 80 mL to ≥ 80 mL/min | 99 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl < 30 mL/min to CrCl ≥ 50 but < 80 mL/min | 8 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl< 30 mL/min to ≥ 80 mL/min | 2 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl≥ 30 but < 50 mL/min to < 30 mL/min | 2 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 80 mL/min to CrCl< 30 mL/min | 1 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 50 but < 80 mL to CrCl ≥ 50 but < 80 mL/min | 102 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 30 but < 50 mL/min to CrCl ≥ 30 but < 50 mL | 41 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 80 mL/min to CrCl< 30 mL/min | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl < 30 mL/min to CrCl ≥ 50 but < 80 mL/min | 5 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 30 but < 50 mL/min to CrCl ≥ 50 but < 80 mL | 65 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 80 mL/min to CrCl ≥ 80 mL/min | 121 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl< 30 mL/min to CrCl< 30 mL/min | 19 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 30 but < 50 mL/min to ≥ 80 mL/min | 2 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 50 but < 80 mL to ≥ 80 mL/min | 97 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl≥ 30 but < 50 mL/min to < 30 mL/min | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 50 but < 80 mL to CrCl< 30 mL/min | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 80 mL/min to CrCl ≥ 30 but < 50 mL/min | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl < 30 mL/min to CrCl ≥ 30 but < 50 mL/min | 19 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 50 but < 80 mL to CrCl ≥ 30 but < 50 mL/min | 4 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl< 30 mL/min to ≥ 80 mL/min | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase | CrCl ≥ 80 mL/min to CrCl ≥ 50 but < 80 mL/min | 9 participants |
Secondary
Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase
Hemoglobin was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.
Time frame: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Population: Safety Population; Includes participants with baseline and postbaseline hemoglobin laboratory test grade information
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 4 Baseline to Grade 2 postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 3 Baseline to Normal postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 1 Baseline to Grade 3 postbaseline | 25 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Normal Baseline Grade to Grade 2 postbaseline | 8 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 2 Baseline to Grade 4 postbaseline | 4 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 1 Baseline to Grade 4 postbaseline | 2 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Normal Baseline Grade to Normal Postbaseline Grade | 6 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 2 Baseline to Grade 3 postbaseline | 48 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 2 Baseline to normal postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 4 Baseline to Normal postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 2 Baseline to Grade 2 postbaseline | 125 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 2 Baseline to Grade 1 postbaseline | 8 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Normal Baseline Grade to Grade 3 postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 4 Baseline to Grade 4 postbaseline | 1 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 3 Baseline to Grade 4 postbaseline | 5 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Normal Baseline Grade to Grade 4 postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 4 Baseline to Grade 3 postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 3 Baseline to Grade 3 postbaseline | 10 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 1 Baseline to Normal postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Normal Baseline Grade to Grade 1 postbaseline | 39 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 3 Baseline to Grade 2 postbaseline | 12 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 1 Baseline to Grade 1 postbaseline | 106 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 4 Baseline to Grade 1 postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 3 Baseline to Grade 1 postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade1 Baseline to Grade 2 postbaseline | 128 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 2 Baseline to Grade 4 postbaseline | 9 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Normal Baseline Grade to Normal Postbaseline Grade | 10 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Normal Baseline Grade to Grade 1 postbaseline | 30 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Normal Baseline Grade to Grade 2 postbaseline | 8 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Normal Baseline Grade to Grade 3 postbaseline | 1 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Normal Baseline Grade to Grade 4 postbaseline | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 1 Baseline to Normal postbaseline | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 1 Baseline to Grade 1 postbaseline | 126 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade1 Baseline to Grade 2 postbaseline | 123 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 1 Baseline to Grade 3 postbaseline | 17 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 1 Baseline to Grade 4 postbaseline | 5 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 2 Baseline to normal postbaseline | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 2 Baseline to Grade 1 postbaseline | 12 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 2 Baseline to Grade 2 postbaseline | 135 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 2 Baseline to Grade 3 postbaseline | 41 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 4 Baseline to Normal postbaseline | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 3 Baseline to Normal postbaseline | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 3 Baseline to Grade 1 postbaseline | 1 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 3 Baseline to Grade 2 postbaseline | 4 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 3 Baseline to Grade 3 postbaseline | 8 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 3 Baseline to Grade 4 postbaseline | 3 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 4 Baseline to Grade 1 postbaseline | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 4 Baseline to Grade 2 postbaseline | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 4 Baseline to Grade 3 postbaseline | 1 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 4 Baseline to Grade 4 postbaseline | 1 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 3 Baseline to Normal postbaseline | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 1 Baseline to Grade 1 postbaseline | 110 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 4 Baseline to Normal postbaseline | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 3 Baseline to Grade 1 postbaseline | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 1 Baseline to Normal postbaseline | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 4 Baseline to Grade 2 postbaseline | 1 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 3 Baseline to Grade 2 postbaseline | 10 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Normal Baseline Grade to Grade 4 postbaseline | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Normal Baseline Grade to Normal Postbaseline Grade | 9 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 3 Baseline to Grade 3 postbaseline | 10 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Normal Baseline Grade to Grade 3 postbaseline | 1 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 4 Baseline to Grade 4 postbaseline | 2 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 3 Baseline to Grade 4 postbaseline | 2 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 2 Baseline to Grade 1 postbaseline | 14 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 2 Baseline to normal postbaseline | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Normal Baseline Grade to Grade 2 postbaseline | 4 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 2 Baseline to Grade 2 postbaseline | 133 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 1 Baseline to Grade 4 postbaseline | 4 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 4 Baseline to Grade 3 postbaseline | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 2 Baseline to Grade 3 postbaseline | 47 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 1 Baseline to Grade 3 postbaseline | 20 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 4 Baseline to Grade 1 postbaseline | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade 2 Baseline to Grade 4 postbaseline | 11 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Grade1 Baseline to Grade 2 postbaseline | 123 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase | Normal Baseline Grade to Grade 1 postbaseline | 25 participants |
Secondary
Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase.
Improvement in platelets was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.
Time frame: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Population: Safety population; Includes participants with baseline and postbaseline platelet laboratory test grade information
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 2 Baseline to Grade 4 postbaseline | 1 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 1 Baseline to Grade 2 postbaseline | 15 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Normal Baseline Grade to Normal Postbaseline Grade | 197 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 2 Baseline to Grade 3 postbaseline | 3 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 1 Baseline to Grade 3 postbaseline | 10 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Normal Baseline Grade to Grade 3 postbaseline | 15 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 2 Baseline to Grade 2 postbaseline | 3 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 1 Baseline to Grade 4 postbaseline | 2 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 3 Baseline to Grade 4 postbaseline | 2 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 2 Baseline to Grade 1 postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 2 Baseline to normal postbaseline Grade | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 3 Baseline to Grade 2 postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Normal Baseline Grade to Grade 4 postbaseline | 4 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 3 Baseline to Grade 3 postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 3 Baseline to Grade 1 postbaseline | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade1 Baseline to Normal postbaseline Grade | 1 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Normal Baseline Grade to Grade 2 postbaseline | 24 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 3 Baseline to Normal postbaseline Grade | 0 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 1 Baseline to Grade 1 postbaseline | 34 participants |
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Normal Baseline Grade to Grade 1 postbaseline | 216 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 3 Baseline to Grade 2 postbaseline | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Normal Baseline Grade to Normal Postbaseline Grade | 197 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Normal Baseline Grade to Grade 1 postbaseline | 211 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Normal Baseline Grade to Grade 2 postbaseline | 30 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Normal Baseline Grade to Grade 3 postbaseline | 12 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Normal Baseline Grade to Grade 4 postbaseline | 5 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade1 Baseline to Normal postbaseline Grade | 3 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 1 Baseline to Grade 1 postbaseline | 38 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 1 Baseline to Grade 2 postbaseline | 19 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 1 Baseline to Grade 3 postbaseline | 12 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 1 Baseline to Grade 4 postbaseline | 1 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 2 Baseline to normal postbaseline Grade | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 2 Baseline to Grade 1 postbaseline | 1 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 2 Baseline to Grade 2 postbaseline | 3 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 2 Baseline to Grade 3 postbaseline | 2 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 2 Baseline to Grade 4 postbaseline | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 3 Baseline to Normal postbaseline Grade | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 3 Baseline to Grade 1 postbaseline | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 3 Baseline to Grade 3 postbaseline | 0 participants |
| Lenalidomide and Dexamethasone Rd18 | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 3 Baseline to Grade 4 postbaseline | 1 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Normal Baseline Grade to Grade 1 postbaseline | 208 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 2 Baseline to Grade 3 postbaseline | 2 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 1 Baseline to Grade 1 postbaseline | 51 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 3 Baseline to Grade 4 postbaseline | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 2 Baseline to Grade 4 postbaseline | 2 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade1 Baseline to Normal postbaseline Grade | 6 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 3 Baseline to Grade 3 postbaseline | 1 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 3 Baseline to Normal postbaseline Grade | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Normal Baseline Grade to Grade 4 postbaseline | 11 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Normal Baseline Grade to Normal Postbaseline Grade | 165 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 3 Baseline to Grade 1 postbaseline | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Normal Baseline Grade to Grade 3 postbaseline | 31 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 2 Baseline to normal postbaseline Grade | 0 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 1 Baseline to Grade 4 postbaseline | 1 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Normal Baseline Grade to Grade 2 postbaseline | 27 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 2 Baseline to Grade 1 postbaseline | 2 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 1 Baseline to Grade 3 postbaseline | 10 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 3 Baseline to Grade 2 postbaseline | 1 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 2 Baseline to Grade 2 postbaseline | 1 participants |
| Melphalan + Prednisone + Thalidomide (MPT) | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. | Grade 1 Baseline to Grade 2 postbaseline | 7 participants |
Secondary
Time to First Response Based on the Investigator Assessment at the Time of Final Analysis
The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria assessed by the investigator.
Time frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm.
Population: Participants who had at least a PR.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Time to First Response Based on the Investigator Assessment at the Time of Final Analysis | 1.8 months |
| Lenalidomide and Dexamethasone Rd18 | Time to First Response Based on the Investigator Assessment at the Time of Final Analysis | 1.8 months |
| Melphalan + Prednisone + Thalidomide (MPT) | Time to First Response Based on the Investigator Assessment at the Time of Final Analysis | 2.8 months |
p-value: <0.00001Wilcoxon (Mann-Whitney)
p-value: 0.46987Wilcoxon (Mann-Whitney)
p-value: <0.00001Wilcoxon (Mann-Whitney)
Secondary
Time to First Response Based on the Review by the IRAC
The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria.
Time frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
Population: Participants who had at least a PR.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | Time to First Response Based on the Review by the IRAC | 1.8 months |
| Lenalidomide and Dexamethasone Rd18 | Time to First Response Based on the Review by the IRAC | 1.8 months |
| Melphalan + Prednisone + Thalidomide (MPT) | Time to First Response Based on the Review by the IRAC | 2.8 months |
p-value: <0.00001Wilcoxon (Mann-Whitney)
p-value: 0.46672Wilcoxon (Mann-Whitney)
p-value: <0.00001Wilcoxon (Mann-Whitney)