A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older.

Phase 3

Completed

Conditions: Newly Diagnosed Multiple Myeloma

Interventions: Drug: Melphalan
Drug: Prednisone
Drug: Aspirin
Drug: Placebo

Registration Number: NCT00405756

Lead Sponsor: Celgene Corporation

Brief Summary: The purpose of this study is to determine whether lenalidomide is safe and effective in the treatment of patients with newly diagnosed Multiple Myeloma who are 65 years of age or older.

Detailed Description: The three phases for the study as originally defined and as represented in the results of 11 May 2010 are:

Double-blind Treatment Phase: Induction Melphalan/prednisone and lenalidomide 10 mg (MPR) (2 treatment arms), or melphalan/prednisone and placebo (MPp) (1 treatment arm) for up to 9 cycles. If disease progression, subjects have the option to enter into the Open-Label Extension Phase. There is also an option to enter into the Follow-Up Phase. If the disease has not progressed, subject can continue on blinded therapy into Maintenance.

Double-blind Treatment Phase: Maintenance One MPR treatment arm (MPR+R) will continue taking lenalidomide 10 mg in Maintenance. The other MPR treatment arm (MPR+p) will take placebo in Maintenance. The MP p treatment arm will take placebo in Maintenance (MPp+p). If disease progression, subjects have the option to enter the Open-Label Extension Phase to obtain treatment with lenalidomide, or to enter into the Follow-up Phase.

Open-label Extension Phase:

Treatment consists of oral lenalidomide (up to 25 mg) with or without dexamethasone until disease progression or treatment is discontinued for any reason until all study subjects are followed for at least 5 years from the date of randomization or have died. Subjects who discontinue from the Open-Label Extension Phase prior to completing a total of 5 years in the study will enter the Follow-up Phase.

Follow-up Phase:

Subjects are followed for overall survival and subsequent anti-myeloma treatment regimens until all subjects in this study are followed for at least 5 years from randomization or have died.

The pre-planned interim analysis for the Independent Data Monitoring Committee (IDMC) showed that the difference in progression-free survival (PFS) between treatment arms MPR+R and MPp+p (the defined primary comparative analysis for this study) surpassed the pre-specified O'Brien-Fleming boundary for superiority. The IDMC recommended the release of this information to the sponsor and also recommended that all patient and physician study participants receive information concerning the full findings of the MM-015 interim analysis. Therefore, due to these recommendations from the IDMC, treatment-arm codes were sent to the clinical trial centers to unblind the treatment arms of their study subjects once the amended protocol was reviewed and approved by the respective country Health Authorities and Ethics Committees. Subject participation in the MM-015 study continued after unblinding to obtain long-term data for all study endpoints, including overall survival.

When the study was unblinded, subjects still on protocol therapy had completed the Double-Blind Induction, and were on monotherapy in Double-Blind Maintenance. Subjects in arm MPR+R continued their monotherapy on lenalidomide. Subjects in arms MPR+p and MPp+p discontinued their placebo monotherapy and went into an observation period in which no antimyeloma therapy was taken. If disease progressed for any subject, the investigator had the option of entering the subject in Open Label Extension Phase to receive lenalidomide therapy (up to 25 mg daily) or the Follow-up Phase. All subjects were to be followed for at least 5 years from the start of the study.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 459

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MPR+p	Placebo	Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
MPp+p	Placebo	Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
MPR+R	Melphalan	Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
MPR+R	Aspirin	Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
MPR+p	Prednisone	Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
MPR+R	Prednisone	Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
MPR+p	Melphalan	Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
MPp+p	Melphalan	Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
MPR+p	Aspirin	Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
MPp+p	Prednisone	Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
MPp+p	Aspirin	Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.

Primary Outcome Measures

Name	Time	Method
Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC)	up to 165 weeks	Data as of 11 May 2010 cutoff. PFS was calculated as the time from randomization to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry \[EBMT/IBMTR/ABMTR\] criteria. PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.

Secondary Outcome Measures

Name	Time	Method
Kaplan Meier Estimates of Progression-free Survival (PFS) From Start of Maintenance Therapy Period Based on the Response Assessment by the Central Adjudication Committee (CAC)	Approximately week 37 (start of cycle 10) to week 165	Data as of 11 May 2010 cutoff. PFS calculated from the start of the Maintenance period to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry \[EBMT/IBMTR/ABMTR\] criteria. PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Kaplan Meier Estimates of Overall Survival (OS)	up to 177 weeks	Data as of 11 May 2010 cutoff. Overall survival (OS) 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. 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 available, or clinical cut-off date, if it was earlier.
Kaplan Meier Estimates of Time to Progression (TTP) Based on the Response Assessment by the Central Adjudication Committee (CAC)	up to 165 weeks	Data as of 11 May 2010 cutoff. TTP was the time between randomization and disease progression as determined by the CAC. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry \[EBMT/IBMTR/ABMTR\] criteria. PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period	Up to 165 weeks	Data as of 11 May 2010 cutoff. Best response was determined by the Central Assessment Committee (CAC) based on the European Group for Blood and Marrow Transplantation (EBMT) criteria: Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of bone lesions, plus other factors); Partial Response (PR)-not all CR criteria, plus \>=50% reduction in serum monoclonal paraprotein plus others; Stable Disease (SD)- not PR or PD; Progressive Disease (PD)- reappearance of monoclonal paraprotein, bone lesions, other; Not Evaluable (NE).
Time to First Response	Up to 66 weeks	Data as of 11 May 2010 cutoff. Time to first response was defined as the time from start of treatment until first response as assessed by the Central Assessment Committee (CMC) based on European Group for Blood and Marrow Transplantation (EBMT) criteria.
Kaplan Meier Estimates for Duration of Response as Determined by the Central Adjudication Committee (CAC)	Up to 149 weeks	Data as of 11 May 2010 cutoff. Duration of myeloma response was defined as the time from the initial response date to the earlier of progressive disease (PD) as determined by the CAC or death on study. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry \[EBMT/IBMTR/ABMTR\] criteria. PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Kaplan Meier Estimates for Time to Next Antimyeloma Therapy	Up to 168 weeks	Data as of 11 May 2010 cutoff. Time to the next antimyeloma therapy was defined as time from randomization to the start of another non-protocol antimyeloma therapy. Participants 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.
Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period	Up to 169 weeks (Double-blind therapy period plus 4 weeks)	Data as of 11 May 2010 cutoff. Participant counts in different categories of TEAEs during the double-blind treatment period. A TEAE is as 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. Dose reduction includes reduction with or without interruption.
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale	Baseline (Day 0), Months 4, 7, 10, 13, 16	Data as of 11 May 2010 cutoff. EORTC QLC-C30 is a 30-item questionnaire to assess the quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); two used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life.
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale	Baseline (Day 0), Months 4, 7, 10, 13, 16	Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale	Baseline (Day 0), Months 4, 7, 10, 13, 16	Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning.
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale	Baseline (Day 0), Months 4, 7, 10, 13, 16	Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning.
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale	Baseline (Day 0), Months 4, 7, 10, 13, 16	Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning.
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale	Baseline (Day 0), Months 4, 7, 10, 13, 16	Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning.
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale	Baseline (Day 0), Months 4, 7, 10, 13, 16	Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems.
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale	Baseline (Day 0), Months 4, 7, 10, 13, 16	Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems.
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale	Baseline (Day 0), Months 4, 7, 10, 13, 16	Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems.
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale	Baseline (Day 0), Months 4, 7, 10, 13, 16	Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems.
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale	Baseline (Day 0), Months 4, 7, 10, 13, 16	Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems.
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale	Baseline (Day 0), Months 4, 7, 10, 13, 16	Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems.
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale	Baseline (Day 0), Months 4, 7, 10, 13, 16	Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems.
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale	Baseline (Day 0), Months 4, 7, 10, 13, 16	Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems.
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale	Baseline (Day 0), Months 4, 7, 10, 13, 16	Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems.
Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale	Baseline (Day 0), Months 4, 7, 10, 13, 16	Data as of 11 May 2010 cutoff. 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 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology.
Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale	Baseline (Day 0), Months 4, 7, 10, 13, 16	Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology.
Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale	Baseline (Day 0), Months 4, 7, 10, 13, 16	Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future.
Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale	Baseline (Day 0), Months 4, 7, 10, 13, 16	Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image.

Trial Locations

Locations (97): University Hospital Innsbruck
🇦🇹
Innsbruck, Austria
Republican Scientific and Practical Centre of Radiation Medicine and Human Ecology
🇧🇾
Gomel, Belarus
AZ St-Jan Brugge Oostende AV
🇧🇪
Brugge, Belgium
UZ Gasthuisberg
🇧🇪
Leuven, Belgium
Fakultni nemocnice Hradec Kralove
🇨🇿
Hradec Kralove, Czech Republic
Erasmus Medisch Centrum
🇳🇱
Rotterdam, Netherlands
Institute of Blood Pathology and Transfusion Medicine of the AMS of Ukraine
🇺🇦
Lviv 79044, Ukraine
Universitair Medisch Centrum Utrecht
🇳🇱
Utrecht, Netherlands
Novosibirsk State Regional Clinical Hospital
🇷🇺
Novosibirsk, Russian Federation
Moscow Regional Research Institute n.a. Vladimirsky
🇷🇺
Moscow, Russian Federation
Zhitomir Regional Clinical Hospital
🇺🇦
Zhitomir, Ukraine
Hematology Oncology Clinics of Australia, Level 5, Mater Medical Centre
🇦🇺
South Brisbane, Queensland, Australia
Frankston Hospital
🇦🇺
Frankston, Australia
Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology
🇦🇺
East Melbourne, Australia
The Alfred Hospital
🇦🇺
Melbourne, Australia
Princess Alexandra Hospital
🇦🇺
Woolloongabba, Australia
Sir Charles Gairdner Hospital
🇦🇺
Nedlands, Australia
University Hospital of Salzburg St Johanns Spital
🇦🇹
Salzburg, Austria
Medical University of Vienna
🇦🇹
Vienna, Austria
Wilhelminenspital
🇦🇹
Vienna, Austria
City Clinical Hospital 9
🇧🇾
Minsk, Belarus
Fakultni nemocnice Brno
🇨🇿
Brno, Czech Republic
Centre Hospitalier Universitaire de Liege
🇧🇪
Liege, Belgium
Fakultni Nemocnice Olomouc
🇨🇿
Olomouc, Czech Republic
Vseobecna Fakultni Nemocnice v Praze
🇨🇿
Prague, Czech Republic
Medicinsk afd. Vejle Sygehus
🇩🇰
Vejle, Denmark
CHU
🇫🇷
Caen, France
CHU Montpellier- Hopital Lapeyronie
🇫🇷
Montpellier Cedex 5, France
CH - Hôpital Dupuytren
🇫🇷
Limoges Cedex 1, France
Assistance Publique - Hôpitaux de Paris AP-HP
🇫🇷
Paris, France
Poliklinik A
🇩🇪
Münster, Germany
Hematology Institute, Hemato-Oncology Division,Davidoff Cancer Center, Rabin MC Beilinson Hospital
🇮🇱
Petch Tikva, Israel
Rambam Medical Center
🇮🇱
Haifa, Israel
A.O.U. San Martino
🇮🇹
Genova, Italy
Samara Regional Clinical Hospital
🇷🇺
Samara, Russian Federation
Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl
🇷🇺
Moscow, Russian Federation
Medicinkliniken
🇸🇪
Boras, Sweden
Medicinska kliniken
🇸🇪
Malmö, Sweden
Hospital Universitario de la Princessa
🇪🇸
Madrid, Spain
Hospital Virgen del Rocio Servicio de Hematologia
🇪🇸
Sevilla, Spain
UniversitatsSpital ZurichKlinik fur Onkologie
🇨🇭
Zurich, Switzerland
Ankara University
🇹🇷
Ankara, Turkey
Institute of Urgent and Recovery Surgery
🇺🇦
Donetsk, Ukraine
Monklands Hospital
🇬🇧
Aidrie, United Kingdom
Marmara School of Medicine
🇹🇷
Istanbul, Turkey
Dnepropetrovsk City Clinical Hospital 4
🇺🇦
Dnepropetrovsk, Ukraine
Kings College Hospital
🇬🇧
London, United Kingdom
Christie NHS Trust Hospital
🇬🇧
Manchester, United Kingdom
University College London Hospitals Cancer Clinical Trials Unitist FloorCentral wing
🇬🇧
London, United Kingdom
St James's University Hospital
🇬🇧
Leeds, United Kingdom
Hæmatologisk afd. B Aalborg Sygehus Syd
🇩🇰
Aalborg, Denmark
Royal Adelaide Hospital Institute of Medical and Veterinary Science
🇦🇺
Adelaide, South Australia, Australia
Policlinico San Matteo Universita Di Pavia
🇮🇹
Pavia 2, Italy
Divisione Di Ematologia Ospedale Cattedra di Ematologia
🇮🇹
Rome, Italy
Azienda Policlinico Umberto I, Universita La Sapienzadi Roma
🇮🇹
Rome, Italy
Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
🇮🇹
Turin, Italy
Hospital Universitario de Salamanca
🇪🇸
Salamanca, Spain
Ltd M.Zodelava Hematology Centre
🇬🇪
Tbilisi, Georgia
Institute of Hematology and Transfusiology
🇬🇪
Tbilisi, Georgia
Policlinico S. Orsola
🇮🇹
Bologna, Italy
Royal Prince Alfred Hospital
🇦🇺
Camperdown, Australia
General Air Force Hospital
🇬🇷
Athens, Greece
Alexandra General Hospital of Athens
🇬🇷
Athens, Greece
Midlands Regional
🇮🇪
Tullamore / Co Offally, Ireland
Medizinische Klinik - Abteilung II
🇩🇪
Tübingen, Germany
Hadassah University Hospital
🇮🇱
Jerusalem, Israel
The Chaim Sheba Medical Center
🇮🇱
Tel Hashomer, Israel
Cherkassy Regional Oncology Center
🇺🇦
Cherkassy, Ukraine
Institute of Hematology and Transfusiology of the UAMS Department of blood diseases
🇺🇦
Kiev, Ukraine
Hospital Clinic
🇪🇸
Barcelona, Spain
Medizinische Klinik und Poliklinik II der Charite Campus Mitte
🇩🇪
Berlin, Germany
Universitatsklinikum Carl Gustav Carus an der TU Dresden
🇩🇪
Dresden, Germany
Erasmus Medical Center
🇳🇱
Rotterdam, Netherlands
Institute of Internal Diseases University of Medicine
🇵🇱
Gdansk, Poland
Dipartmento Oncologico Struttura Complessa di ematlologiaA.O. Ospedale Niguarda Ca Granda
🇮🇹
Milano, Italy
Dipartimento di Onco-Ematologia
🇮🇹
San Giovanni Rotondo (FG), Italy
Ege University Medical School
🇹🇷
Izmir, Turkey
Hospital Universitaro Puerta del MarServicio de Hematologia
🇪🇸
Cadiz, Spain
VU Medical Center
🇳🇱
Amsterdam, Netherlands
Oddzial Kliniczny Kliniki Hematologii
🇵🇱
Krakow, Poland
Akademia Medyczna w Warszawie Samodzielny Publiczny Centralny Szpital Kliniczny
🇵🇱
Warsaw, Poland
Uniwersytet Medyczny w Lodzi
🇵🇱
Lodz, Poland
University School of Medicine
🇵🇱
Lublin, Poland
Burdenko Central Military Clinical Hospital
🇷🇺
Moscow, Russian Federation
Klinika Hematologii Samodzielny Publiczny Szpital Kliniczny Akademii
🇵🇱
Bialystok, Poland
St. Petersburg Research Institute of Hematology and Blood Transfusion
🇷🇺
St. Petersburg, Russian Federation
AZ-VUB
🇧🇪
Brussels, Belgium
G. GENNIMATAS General Hospital of Athens Department of Hematolgosy
🇬🇷
Athens, Greece
CHU Purpan
🇫🇷
Toulouse cedex 9, France
Medizinische Klinik und Poliklinik II
🇩🇪
Leipzig, Germany
Ernst-Moritz-Arndt-Universität Greifswald
🇩🇪
Greifswald, Germany
Medizinische Universitatsklinik
🇩🇪
Ulm, Germany
Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik
🇩🇪
Freiburg, Germany
Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V
🇩🇪
Heidelberg, Germany
Hope Directorate Haematology Oncology Service St. James Hospital
🇮🇪
Dublin, Ireland
Medizinische Klinik und Poliklinik II des Universitatsklinikums Wurzburg
🇩🇪
Würzburg, Germany
Medical Radiological Research Center RAMS
🇷🇺
Obninsk, Russian Federation