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Trial record 55 of 376 for:    LENALIDOMIDE AND Dexamethasone

Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma (FIRST)

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ClinicalTrials.gov Identifier: NCT00689936
Recruitment Status : Completed
First Posted : June 4, 2008
Results First Posted : August 11, 2017
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Lenalidomide and low-dose dexamethasone Drug: Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles Drug: Melphalan, Prednisone and Thalidomide Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1623 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Open-label, 3-arm Study to Determine the Efficacy and Safety of Lenalidomide(REVLIMID) Plus Low-dose Dexamethasone When Given Until Progressive Disease or for 18 Four-week Cycles Versus the Combination of Melphalan, Prednisone, and Thalidomide Given for 12 Six-week Cycles in Patients With Previously Untreated Multiple Myeloma Who Are Either 65 Years of Age or Older or Not Candidates for Stem Cell Transplantation.
Actual Study Start Date : August 21, 2008
Actual Primary Completion Date : July 14, 2016
Actual Study Completion Date : July 14, 2016


Arm Intervention/treatment
Experimental: Lenalidomide / Dexamethasone until disease progression
Lenalidomide plus low-dose dexamethasone given until disease progression
Drug: Lenalidomide 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

Other Name: Revlimid

Experimental: Lenalidomide / Dexamethasone for 18 cycles
Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles
Drug: Lenalidomide 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

Other Name: Revlimid

Active Comparator: Melphalan, Prednisone, and Thalidomide (MPT) for 12 cycles
Combination of Melphalan, Prednisone and Thalidomide given for 12 six-week cycles
Drug: Melphalan, Prednisone and Thalidomide
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
Other Names:
  • Prednisone
  • Thalomid




Primary Outcome Measures :
  1. Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC) [ 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. ]
    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).

  2. Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis [ 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 ]
    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 Outcome Measures :
  1. Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS) [ 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 ]
    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.

  2. Percentage of Participants With an Objective Response Based on IRAC Review [ 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 ]
    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.

  3. Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis [ 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 ]
    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.

  4. Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC [ 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 ]
    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.

  5. Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis [ 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 ]
    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.

  6. Time to First Response Based on the Review by the IRAC [ 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 ]
    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.

  7. Time to First Response Based on the Investigator Assessment at the Time of Final Analysis [ 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. ]
    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.

  8. Kaplan Meier Estimates of Time to Treatment Failure (TTF) [ 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. ]
    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.

  9. Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis [ 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. ]
    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.

  10. Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT) [ 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 ]
    Time to second-line anti-myeloma therapy was defined as time from randomization to the start of another non-protocol anti-myeloma therapy.

  11. Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis [ 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 ]
    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.

  12. Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis [ 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 ]
    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.

  13. Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review. [ 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 ]
    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.

  14. Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review [ 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 ]
    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.

  15. Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review [ 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 ]
    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.

  16. Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review [ 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 ]
    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.

  17. 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 [ Time Frame: 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.

  18. Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain [ Time Frame: 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.

  19. Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain [ Time Frame: 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.

  20. Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain [ Time Frame: 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.

  21. Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain [ Time Frame: 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.

  22. Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain [ Time Frame: 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.

  23. Change From Baseline in the EORTC QLQ-C30 Fatigue Domain [ Time Frame: 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.

  24. Change From Baseline in the EORTC QLQ-C30 Pain Domain [ Time Frame: 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.

  25. Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain [ Time Frame: 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.

  26. Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain [ Time Frame: 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.

  27. Change From Baseline in the EORTC QLQ-C30 Insomnia Domain [ Time Frame: 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.

  28. Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain [ Time Frame: 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.

  29. Change From Baseline in the EORTC QLQ-C30 Constipation Domain [ Time Frame: 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.

  30. Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain [ Time Frame: 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.

  31. Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain [ Time Frame: 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.

  32. 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 [ Time Frame: 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).

  33. 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 [ Time Frame: 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.

  34. 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 [ Time Frame: 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.

  35. 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 [ Time Frame: 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.

  36. Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score [ Time Frame: 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.

  37. Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year [ Time Frame: 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.

  38. Number of Participants With Adverse Events (AEs) During the Active Treatment Phase [ 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 ]
    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.

  39. Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase [ 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 ]
    Renal function was assessed for participants from baseline to the most extreme value in creatinine clearance calculated using the Cockcroft-Gault estimation.

  40. Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase [ 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 ]
    Neutrophil counts was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.

  41. Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase [ 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 ]
    Hemoglobin was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.

  42. Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. [ 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 ]
    Improvement in platelets was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.

  43. Improvement of Infection Rate by Observing the Historical Data Compared to the Clinical Data Base [ Time Frame: From randomization to 24 May 2013 ]
    Improvement of infection rate by observing historical data compared to the data within clinical database as not analyzed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00689936


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
University of AL Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Cedar Sinai Medical Center Dept of Medicine
Los Angeles, California, United States, 90048
University of California, San Francisco- California
San Francisco, California, United States, 94143
Stanford University Stanford
Stanford, California, United States, 94305
United States, Florida
Gainesville Heme Oncology Associates
Gainesville, Florida, United States, 32607
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Integrated Community Oncology Network
Orange Park, Florida, United States, 32073
Gulf Coast Oncology
Saint Petersburg, Florida, United States, 33705
Palm Beach Cancer Institute, LLC
West Palm Beach, Florida, United States, 33401
United States, Illinois
Southern Illinois Hematology Oncology
Centralia, Illinois, United States, 62801
Orchard Healthcare Research, Inc.
Chicago, Illinois, United States, 60611
John H Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
Rush University Medical Center
Chicago, Illinois, United States, 60612
Ingalls Cancer Institute
Harvey, Illinois, United States, 60426-3558
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67124
United States, Maine
Maine Center for Cancer Medicine Blood Disorders
Scarborough, Maine, United States, 04074
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Montana
Billings Clinic
Billings, Montana, United States, 59107
United States, New York
Arena Oncology Associates, PC
Lake Success, New York, United States, 11042
United States, North Dakota
Dakota Cancer Institute
Fargo, North Dakota, United States, 58103
United States, Ohio
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
Kaiser Permanente Northwest Oncology Hematology
Portland, Oregon, United States, 97227
United States, Pennsylvania
St. Luke's Hospital and Health Network
Allentown, Pennsylvania, United States, 18104
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
The Cancer Center
Collierville, Tennessee, United States, 38017
University of Tennessee Cancer Institute
Memphis, Tennessee, United States, 38104
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0561
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology
E. Melbourne, Victoria, Australia, 3002
Western Hospital
Footscray, Victoria, Australia, 3011
Frankston Hospital
Frankston, Victoria, Australia, 3199
Australia
Flinders Medical Centre
Bedford Park, Australia, 5042
Geelong Hospital
Geelong, Australia, 3220
Gosford Hospital
Gosford, Australia, 2250
Royal Brisbane and Women's Hospital
Herston, Australia, 4029
Cabrini Hospital
Malvern, Australia, 3144
The Royal Melbourne Hospital
Parkville, Australia, 3050
Royal Perth Hospital
Perth, Australia, 6000
Gold Coast Hospital
Southport, Australia, 4215
Royal North Shore Hospital
St Leonards, Australia, 2065
Westmead Hospital
Wentworthville, Australia, 2145
Border Medical Oncology
Wodonga, Australia, 3690
Wollongong Hospital
Wollongong, Australia, 2500
Princess Alexandra Hospital
Woolloongabba, Australia, 4102
Austria
Hospital Leoben
Leoben, Austria, 8700
Hospital of Barmherzige Schwestern Linz
Linz, Austria, 4010
Hospital of Elisabethinen Linz
Linz, Austria, 4010
General Hospital Linz
Linz, Austria, 4021
MM-015. Salzburger Landkliniken, St. Johanns-Spital, Universitätsklinik fur Innere Medizin III
Salzburg, Austria, 5020
Hospital St. Polten
St. Pölten, Austria, 3100
Hospital of the Barmherzigen Bruder Vienna
Vienna, Austria, 1020
MM-015.Wihelminenspital
Vienna, Austria, 1160
MM-015. Medizinische Universität Wien
Vienna, Austria, A-1090
Hospital Wels
Wels, Austria, 4600
Hospital Wiener Neustadt
Wiener Neustadt, Austria
Belgium
ZNA Stuivenberg Centrumziekenhuis
Antwerpen, Belgium, 2069
Les Cliniques du Sud Luxembourg
Arlon, Belgium, 6700
AZ St-Jan Brugge Oostende AV
Brugge, Belgium, 8000
Hopital Erasme
Brussels, Belgium, 1070
AZ-VUB
Brussels, Belgium, 1090
Jules Bordet Institut
Brussel, Belgium, 1000
Cliniques Universitaires St-Luc
Bruxelles, Belgium, 1200
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
UZ Gent
Gent, Belgium, 9000
Virga Jesse Ziekenhuis
Hasselt, Belgium, 3500
Universitair Ziekenhuis Leuven, Campus Gasthuisberg
Leuven, Belgium, 3000
H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat
Roeselare, Belgium, 8800
Cliniques Universitaires UCL de Mont-Godine
Yvoir, Belgium, 5530
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 2T9
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency
Kelowna, British Columbia, Canada, V1Y 5L3
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3M 1X4
BC Cancer Agency - Fraser Valley Centre
Surrey, British Columbia, Canada, V3V 1Z2
Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp
Vancouver, British Columbia, Canada, V5Z 1M9
Vancouver Island Cancer Center
Victoria, British Columbia, Canada, V8R 6V5
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 3L6
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada, B3H2Y9
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Health Science Centre
London, Ontario, Canada, N6A 4G5
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hospital Charles LeMoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital de la Cite-de-la-Sante
Laval, Quebec, Canada, H7M 3L9
Hotel-Dieu de Levis
Levis, Quebec, Canada, G5V 3Z1
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, G4H 1C5
Hospital Maisonneuve - Rosemont
Montreal, Quebec, Canada, H1T 2M4
CHUM- Hopital Notre-Dame
Montreal, Quebec, Canada, H2L4M1
McGill University
Montreal, Quebec, Canada, H2W 1S6
Sir Mortimer B. Davis - Jewish Genl
Montreal, Quebec, Canada, H3T 1E2
Canada
CHUQ - Hotel-Dieu de QuebecHematology - Oncology
Quebec, Canada, G1R 2J6
China
Chaoyang Hospital
Beijing, China, 100020
Peking University People's Hospital
Beijing, China, 100044
West China Hospital of Sichuan University
Chengdu, China, 610041
Ruijin Hospital Shanghai Jiaotong University
Shanghai, China, 200025
Blood Disease Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Tianjin, China, 300041
France
Clinique Claude BernardOncologie
Albi, France, 81000
CHU Sud
Amiens, France, 80054
CHRU Hopital du bocage
Angers cedex 01, France, 49033
CH Argenteuil Victor Dupouy
Argenteuil, France, 95100
Centre Hospitalier de la cote basque
Bayonne, France, 64109
Centre Hospitalier
Blois cedex, France, 41016
Hopital Avicenne
Bobigny Cedex, France, 93009
Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
Bordeaux, France, 33076
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33300
Hopital de Fleyriat
Bourg en Bresse cedex, France, 01012
Hopital Augustin Morvan
Brest cedex, France, 29609
Centre Francois Baclesse
Caen cedex 5, France, 14076
CHU
Caen, France, 14033
CH
Cannes Cedex, France, 06401
CH Rene Dubois
Cergy-Pontoise, France, 95303
Centre Hospitalier William Morey
Chalon/Saone Cedex, France, 71321
Hopital dinstruction des armees Percy
Clamart Cedex, France, 92141
Hopital Antoine Beclere
Clamart, France, 92141
Chu Estaing
Clermont Ferrand, France, 63000
CH Louis Pasteur
Colmar cedex, France, 68024
Hopital Henri Mondor
Creteil, France, 94010
CHRU Hopital du bocage
Dijon, France, 21034
Centre Hospitalier General
Dunkerque, France, 59385
CHRU
Grenoble cedex 09, France, 38043
Institut Prive de Cancerologie
Grenoble, France, 38034
Centre Hospitalier Departemental
La Roche -Sur-Yon cedex 9, France, 85925
CH
Le Chesnay Cedex, France, 78157
Hopital J MonodRhumato Nord
Le Havre, France, 76000
Kremlin Bicetre
Le Kremlin bicetre CDX, France, 942975
Centre Hospitalier
Le Mans cedex, France, 72037
Centre Jean Bernard
Le Mans, France, 72000
CHRU-Hopital Claude Huriez
Lille cedex, France, 59037
GH de Institut Catholique St Vincent
Lille, France, 59000
CH - Hôpital Dupuytren
Limoges Cedex 1, France, 87042
CHU Hopital Edouard Herriot
Lyon cedex, France, 69437
Centre Leon Berard
Lyon, France, 69008
Centre Hospitalier de Valence
Lyon, France, 69495
Institut Paoli-Calmettes
Marseille Cedex 9, France, 13009
Hopital de Mercy
METZ cedex 3, France, 57085
Clinique Pont de chaume Oncologie et Radiotherapie
Montauban cedex, France, 82017
CHU Montpellier - Hôpital Lapeyronie
Montpellier Cedex 5, France, 34295
Hopital Emile Muller
Mulhouse, France, 68000
CHRU - Hotel Dieu
Nantes, France, 44035
Centre Antoine Lacassagne Oncologie medicale et Hematologie
Nice cedex 1, France, 06050
Hopital de lArchet 1
Nice cedex 3, France, 06202
CH La Source
Orleans, France, 45000
Hopital Cochin
Paris Cedex 14, France, 75679
Hopital Saint Louis
Paris, France, 75010
Hopital Necker
Paris, France, 75015
CHU Hôpital St-Antoine
Paris, France, 75571
CHRU - Hopital du Haut Leveque
Pessac, France, 33604
CU CHU Clemenceau
Poitiers cedex, France, 86021
Hopital R. Debre
Reims cedex, France, 51032
CHU Reims - Hôpital Maison Blanche
Reims, France, 51100
CHRU Hopital sud Medecine Interne
Rennes cedex 02, France, 35056
CHRU Hôpital de Pontchaillou
Rennes Cedex, France, 35033
CHG Rodez
Rodez, France, 12027
Centre Henri Becquerel
Rouen cedex, France, 76038
Centre Rene Huguenin
Saint Cloud, France, 92210
Institut de Cancerologie de Loire
St Priest en Jarez, France, 42270
Centre Hospitalier Yves Le Foll
St-Brieuc cedex 1, France, 22027
CHRU Hôpital de Hautepierre
Strasbourg, France, 67098
CHRU Hopital Purpan
Toulouse cedex 9, France, TSA 40031-31059
CHRU Hopital Bretonneau
Tours cedex, France, 37044
CHRU Hopital Trousseau
Tours, France, 37044
CHRU Hôpitaux de Brabois
Vandoeuvre Cedex, France, 54511
CH P. Chubert
Vannes cedex, France, 56017
Institut Gustave Roussy
Villejuif, France, 94805
Germany
Medizinische Kinik und Poliklinik I
Dresden, Germany, D-01307
Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
Dusseldorf, Germany, 40225
Universitatsklinikum Essen-
Essen, Germany, 45122
Staedtische Kliniken Frankfurt am Main Hochst
Frankfurt am Main, Germany, 65929
Universitatsklinikum Giessen
Giessen, Germany, 35385
Ernst-Moritz-Arndt-Universität Greifswald
Greifswald, Germany, 17487
Askepios Klinik St. Georg
Hamburg, Germany, 20099
Universitatsklinikum Jena
Jena, Germany, 07740
Medizinische Klinik und Poliklinik II
Leipzig, Germany, 04103
Universitatsklinikum schleswig-Holstein
Lübeck, Germany, 23538
Poliklinik A
Muenster, Germany, 48129
Klinikum der Johann-Wolfgang-Goethe-Universtat
München, Germany, 81377
Medizinische Klinik III Klinikum der Universität München-Großhadern
München, Germany, 81377
Medizinische Fakultat der Universitat Rostock
Rostock, Germany, 18057
Zentrum F. Innere Medizin II Robert- Bosch-Krankenhaus GmBH
Stuttgart, Germany, D -70376
Medizinische Klinik - Abteilung II
Tübingen, Germany, 72076
Klinik fur Innere Medizin III
Ulm, Germany, 89081
Greece
Alexandra Hospital, University of Athens
Athens, Greece, 11528
Attiko Hospital of Athens
Athens, Greece, 124
Evangelismos Hospital of Athens
Athens, Greece
University of Athens
Athens, Greece
Metaxa Hospital Peiraias
Piraeus, Greece, 18537
Theagenio Anticancer Hospital of Thessaloniki
Thessaloniki, Greece, 540 07
Ireland
Adelaide and Meath Hospital
Dublin, Ireland, 24
Mater Misercordiae Hospital
Dublin, Ireland, 7
University Hospital Galway
Galway, Ireland, ST46QG
Italy
Policlinico S. Orsola
Bologna, Italy, 40138
Oncologia Medica, Università della Magna Grecia
Catanzaro, Italy, 88100
Clinica Ematologica, A.O.U. San Martino di Genova
Genova, Italy, 16132
Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce
Lecce, Italy, 73100
Unità Operativa di Oncoematologia, Ospedale di Matera
Matera, Italy, 75100
U.O. di Ematologia e Trapianto di Midollo Osseo
Milano, Italy, 20132
Istituto Europeo di Oncologia - IEO
Milano, Italy, 20141
Presidio Ospedaliero A. Perrino
Milano, Italy, 20141
Policlinico di Modena
Modena, Italy, 41100
Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Italy, 80131
Casa di Cura La Maddalena, Divisione di Ematologia
Palermo, Italy, 90146
Policlinico San Matteo Universita Di Pavia
Pavia 2, Italy, 27100
Ospedale Civile
Piacenza, Italy, 29100
A.O. Universitaria Ospedale S.Chiara Dip.Oncologia, Div. Ematologia
Pisa, Italy, 56126
Arcispedale Santa Maria Nuova
Reggio Emilia, Italy, 42100
Istituto Nazionale Tumori Regina Elena, Struttura Complessa Ematologia ed Unita di Cellule Staminali
Roma, Italy, 00144
Azienda Policlinico Umberto I, Universita La Sapienzadi Roma
Rome, Italy, 00161
Ospedale Molinette
Torino, Italy, 10126
Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang, Korea, Republic of, 431-070
Inje University Busan Paik Hospital
Busan, Korea, Republic of, 614-735
Daegu Catholic University Medical Center 3056-6
Daegu, Korea, Republic of, 705-718
Chungnam National University Hospital
Daejon, Korea, Republic of, 301-721
National Cancer Center
Gyeonggi-do, Korea, Republic of, 410-769
Hwasun Chonnam National University Hospital
Hwasun-goon, Korea, Republic of, 519-803
Gachon University Gil Hospital
Incheon, Korea, Republic of, 405-760
Chonbuk National University Hospital 42
Jeonju, Korea, Republic of, 561-712
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of, 463-707
Severance Hospital
Seongsanno, Korea, Republic of, 120-752
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
The Catholic University of Korea Seoul - Saint Mary's Hospital
Seoul, Korea, Republic of, 137-701
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of, 158-710
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1023
Christchurch Hospital
Christchurch, New Zealand, 8011
Wellington Hospital
Newtown, New Zealand, 6021
Portugal
Hospital de Sao Marcos
Braga, Portugal
Hospitais da Universidade de Coimbra
Coimbra, Portugal, 3000-075
Instituto Portugues de Oncologia de Lisboa
Lisboa, Portugal, 1099-023
Hospital de Santa Maria
Lisboa, Portugal, 1649-035
Instituto Português de Oncologia Porto
Porto, Portugal, 4200-072
Hospital de Santo Antonio- Porto
Porto, Portugal
Spain
Hospital Universitari Germans Trias i Pujol
Badalona (Barcelona), Spain, 8916
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Instituto Catalan de Oncologia-Hospital Duran
Barcelona, Spain, 08907
Hospital Reina Sofia
Cordoba, Spain, 14004
Hospital Univ. Josep Trueta
Girona, Spain, 17007
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital General Universitario Morales Messeguer
Murcia, Spain, 30008
Hospital Clinico Virgen de la Victoria
Málaga, Spain, 29010
Hospital Son Llatzer
Palma de Mallorca, Spain, 7198
Clinica Universitaria de Navarra,
Pamplona, Spain, 31008
Hospital Sant Pau
Reus, Spain, 43201
Hospital de Donosti
San Sebastian, Spain, 20014
Hospital Universtario Marques de Valdecilla
Santander, Spain, 39008
Hospital Clinico Santiago de Compostela
Santiago de Compostela, Spain, 15706
Hosptial La Fe
Valencia, Spain, 46009
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain, 50009
Hospital Miguel Servet
Zaragoza, Spain, 50009
Sweden
Linkoping University Hospital
Linkoping, Sweden, SE 581 85
Karolinska University HospitalSolna
Stockholm, Sweden, SE 17176
St. Görans Hospital
Stockholm, Sweden, SE- 11281
Karolinska University Hospital Huddinge
Stockholm, Sweden, SE-14186
Switzerland
Abteilung Onkologie Haematologie des Kantonsspitals Aarau
Aarau, Switzerland, 5001
UniversitatsSpital Basel
Basel, Switzerland, 4031
Inselsspital Bern
Berne, Switzerland, 3010
Kantonsspital Graubunden
Chur, Switzerland, 7000
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, Switzerland, 1011
Kantonsspital Munsterlingen
Münsterlingen (TG), Switzerland, 8596
Kantonsspital Winterthur
Winterthur, Switzerland, 8400
Taiwan
China Medical University Hospital
Taichung City, Taiwan, 40447
Veteran General Hospital - Taipei
Taipei, Taiwan, 11217
National Taiwan University Hospital
Tapei, Taiwan, 10002
United Kingdom
Gwynedd Hospital
Bangor, United Kingdom, LL57 2PW
Royal United Hospital
Bath, United Kingdom, BA1 3NG
Belfast City Hospital Haematology Department
Belfast Northern Ireland, United Kingdom, BT9 7AB
Birminghman QE
Birmingham West Midlands, United Kingdom, B15 2TH
Royal Bournemouth Hosp
Bournemouth Dorset, United Kingdom, BH7 7DW
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 2QQ
University Hospital of Wales - Cardiff
Cardiff, United Kingdom, CF14 4XW
The Beatson West of Scotland Centre
Glasgow, United Kingdom, G12 0YN
Dept of Haematology St Bartholomews Hospital
London, United Kingdom, EC1A 7BE
Guy's and St Thomas' Hospital - London
London, United Kingdom, SE1 9RT
Royal Free Hospital
London, United Kingdom, W12 0HS
Churchhill Hospital
Oxford, United Kingdom, OX3 7LI
Derriford Hospital
Plymouth Crownhill Devon, United Kingdom, PL6 8DH
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
Sheffield, United Kingdom, S10 2JF
Pinderfields General Hospital
West Yorkshire, United Kingdom, WF1 4DG
New Cross Hospital- Wolverhampton
Wolverhampton, United Kingdom, WV10 OPQ
Sponsors and Collaborators
Celgene
Investigators
Layout table for investigator information
Study Director: Christian Jacques, MD Celgene Corporation

Additional Information:
Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00689936     History of Changes
Other Study ID Numbers: CC-5013-MM-020
2007-004823-39 ( EudraCT Number )
First Posted: June 4, 2008    Key Record Dates
Results First Posted: August 11, 2017
Last Update Posted: April 26, 2018
Last Verified: April 2018
Keywords provided by Celgene:
newly diagnosed multiple myeloma
Lenalidomide
Revlimid
phase III
Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Lenalidomide
BB 1101
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Thalidomide
Prednisone
Melphalan
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists