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

• ClinicalTrials.gov Identifier: NCT00689936
• Recruitment Status: Completed
• First Posted: June 4, 2008
• Results First Posted: August 11, 2017
• Last Update Posted: November 20, 2019
• Sponsor: Celgene
• Information provided by (Responsible Party): Celgene

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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).

Contacts and Locations

Locations

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

• Study Director: Christian Jacques, MD; Celgene Corporation

More Information

Additional Information:

Link to CSR synopsis 

Publications of Results:

Bahlis NJ, Corso A, Mugge LO, Shen ZX, Desjardins P, Stoppa AM, Decaux O, de Revel T, Granell M, Marit G, Nahi H, Demuynck H, Huang SY, Basu S, Guthrie TH, Ervin-Haynes A, Marek J, Chen G, Facon T. Benefit of continuous treatment for responders with newly diagnosed multiple myeloma in the randomized FIRST trial. Leukemia. 2017 Nov;31(11):2435-2442. doi: 10.1038/leu.2017.111. Epub 2017 Apr 4.

Lu J, Lee JH, Huang SY, Qiu L, Lee JJ, Liu T, Yoon SS, Kim K, Shen ZX, Eom HS, Chen WM, Min CK, Kim HJ, Lee JO, Kwak JY, Yiu W, Chen G, Ervin-Haynes A, Hulin C, Facon T. Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial. Br J Haematol. 2017 Mar;176(5):743-749. doi: 10.1111/bjh.14465. Epub 2017 Jan 20.

Other Publications:

Dimopoulos MA, Cheung MC, Roussel M, Liu T, Gamberi B, Kolb B, Derigs HG, Eom H, Belhadj K, Lenain P, Van der Jagt R, Rigaudeau S, Dib M, Hall R, Jardel H, Jaccard A, Tosikyan A, Karlin L, Bensinger W, Schots R, Leupin N, Chen G, Marek J, Ervin-Haynes A, Facon T. Impact of renal impairment on outcomes with lenalidomide and dexamethasone treatment in the FIRST trial, a randomized, open-label phase 3 trial in transplant-ineligible patients with multiple myeloma. Haematologica. 2016 Mar;101(3):363-70. doi: 10.3324/haematol.2015.133629. Epub 2015 Dec 11.

Hulin C, Belch A, Shustik C, Petrucci MT, Duhrsen U, Lu J, Song K, Rodon P, Pegourie B, Garderet L, Hunter H, Azais I, Eek R, Gisslinger H, Macro M, Dakhil S, Goncalves C, LeBlanc R, Romeril K, Royer B, Doyen C, Leleu X, Offner F, Leupin N, Houck V, Chen G, Ervin-Haynes A, Dimopoulos MA, Facon T. Updated Outcomes and Impact of Age With Lenalidomide and Low-Dose Dexamethasone or Melphalan, Prednisone, and Thalidomide in the Randomized, Phase III FIRST Trial. J Clin Oncol. 2016 Oct 20;34(30):3609-3617. doi: 10.1200/JCO.2016.66.7295.

Delforge M, Minuk L, Eisenmann JC, Arnulf B, Canepa L, Fragasso A, Leyvraz S, Langer C, Ezaydi Y, Vogl DT, Giraldo-Castellano P, Yoon SS, Zarnitsky C, Escoffre-Barbe M, Lemieux B, Song K, Bahlis NJ, Guo S, Monzini MS, Ervin-Haynes A, Houck V, Facon T. Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide. Haematologica. 2015 Jun;100(6):826-33. doi: 10.3324/haematol.2014.120121. Epub 2015 Mar 13.

Benboubker L, Dimopoulos MA, Dispenzieri A, Catalano J, Belch AR, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis N, Banos A, Tiab M, Delforge M, Cavenagh J, Geraldes C, Lee JJ, Chen C, Oriol A, de la Rubia J, Qiu L, White DJ, Binder D, Anderson K, Fermand JP, Moreau P, Attal M, Knight R, Chen G, Van Oostendorp J, Jacques C, Ervin-Haynes A, Avet-Loiseau H, Hulin C, Facon T; FIRST Trial Team. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. N Engl J Med. 2014 Sep 4;371(10):906-17. doi: 10.1056/NEJMoa1402551.

Vogl DT, Delforge M, Song K, Guo S, Gibson CJ, Ervin-Haynes A, Facon T. Long-term health-related quality of life in transplant-ineligible patients with newly diagnosed multiple myeloma receiving lenalidomide and dexamethasone. Leuk Lymphoma. 2018 Feb;59(2):398-405. doi: 10.1080/10428194.2017.1334125. Epub 2017 Jun 22.

Dumontet C, Hulin C, Dimopoulos MA, Belch A, Dispenzieri A, Ludwig H, Rodon P, Van Droogenbroeck J, Qiu L, Cavo M, Van de Velde A, Lahuerta JJ, Allangba O, Lee JH, Boyle E, Perrot A, Moreau P, Manier S, Attal M, Roussel M, Mohty M, Mary JY, Civet A, Costa B, Tinel A, Gaston-Mathe Y, Facon T. A predictive model for risk of early grade >/= 3 infection in patients with multiple myeloma not eligible for transplant: analysis of the FIRST trial. Leukemia. 2018 Jun;32(6):1404-1413. doi: 10.1038/s41375-018-0133-x. Epub 2018 Apr 26.

Ailawadhi S, Jacobus S, Sexton R, Stewart AK, Dispenzieri A, Hussein MA, Zonder JA, Crowley J, Hoering A, Barlogie B, Orlowski RZ, Rajkumar SV. Disease and outcome disparities in multiple myeloma: exploring the role of race/ethnicity in the Cooperative Group clinical trials. Blood Cancer J. 2018 Jul 6;8(7):67. doi: 10.1038/s41408-018-0102-7.

Jain T, Sonbol MB, Firwana B, Kolla KR, Almader-Douglas D, Palmer J, Fonseca R. High-Dose Chemotherapy with Early Autologous Stem Cell Transplantation Compared to Standard Dose Chemotherapy or Delayed Transplantation in Patients with Newly Diagnosed Multiple Myeloma: A Systematic Review and Meta-Analysis. Biol Blood Marrow Transplant. 2019 Feb;25(2):239-247. doi: 10.1016/j.bbmt.2018.09.021. Epub 2018 Sep 20.

Facon T, Dimopoulos MA, Dispenzieri A, Catalano JV, Belch A, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis NJ, Banos A, Tiab M, Delforge M, Cavenagh JD, Geraldes C, Lee JJ, Chen C, Oriol A, De La Rubia J, White D, Binder D, Lu J, Anderson KC, Moreau P, Attal M, Perrot A, Arnulf B, Qiu L, Roussel M, Boyle E, Manier S, Mohty M, Avet-Loiseau H, Leleu X, Ervin-Haynes A, Chen G, Houck V, Benboubker L, Hulin C. Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma. Blood. 2018 Jan 18;131(3):301-310. doi: 10.1182/blood-2017-07-795047. Epub 2017 Nov 17.

Ailawadhi S, DerSarkissian M, Duh MS, Lafeuille MH, Posner G, Ralston S, Zagadailov E, Ba-Mancini A, Rifkin R. Cost Offsets in the Treatment Journeys of Patients With Relapsed/Refractory Multiple Myeloma. Clin Ther. 2019 Mar;41(3):477-493.e7. doi: 10.1016/j.clinthera.2019.01.009. Epub 2019 Feb 14.

Pegourie B, Karlin L, Benboubker L, Orsini-Piocelle F, Tiab M, Auger-Quittet S, Rodon P, Royer B, Leleu X, Bareau B, Cliquennois M, Fuzibet JG, Voog E, Belhadj-Merzoug K, Decaux O, Rey P, Slama B, Leyronnas C, Zarnitsky C, Boyle E, Bosson JL, Pernod G; IFM Group. Apixaban for the prevention of thromboembolism in immunomodulatory-treated myeloma patients: Myelaxat, a phase 2 pilot study. Am J Hematol. 2019 Jun;94(6):635-640. doi: 10.1002/ajh.25459. Epub 2019 Apr 1.

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT00689936
• Other Study ID Numbers: CC-5013-MM-020; 2007-004823-39 ( EudraCT Number )
• First Posted: June 4, 2008
• Results First Posted: August 11, 2017
• Last Update Posted: November 20, 2019
• Last Verified: November 2019

Keywords provided by Celgene:

newly diagnosed multiple myeloma; Lenalidomide; Revlimid; phase III

Additional relevant MeSH terms:

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; Dexamethasone; Dexamethasone acetate; Prednisone; Lenalidomide; Melphalan; BB 1101; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists