Please note that the ANZCTR website will be unavailable from 6pm until 6.30pm (AEST) on Monday 22nd July for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00405756




Registration number
NCT00405756
Ethics application status
Date submitted
29/11/2006
Date registered
30/11/2006
Date last updated
11/01/2017

Titles & IDs
Public title
A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older.
Scientific title
A Phase III, Multicentre, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Parallel Group Study To Determine The Efficacy And Safety Of Lenalidomde (Revlimid®) In Combination With Melphalan And Prednisone Versus Placebo Plus Melphalan And Prednisone In Subjects With Newly Diagnosed Multiple Myeloma Who Are 65 Years Of Age Or Older
Secondary ID [1] 0 0
2006-001865-41
Secondary ID [2] 0 0
CC-5013-MM-015
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Newly Diagnosed Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lenalidomide: Double-blind Induction
Treatment: Drugs - Melphalan
Treatment: Drugs - Prednisone
Treatment: Drugs - Aspirin
Treatment: Drugs - Placebo
Treatment: Drugs - Lenalidomide: Double-blind Maintenance
Treatment: Drugs - Lenalidomide: Open-label

Experimental: MPR+R - 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.

Experimental: MPR+p - 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.

Other: MPp+p - 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.


Treatment: Drugs: Lenalidomide: Double-blind Induction
Double-blind Induction: the starting lenalidomide oral dosing regimen was 10 mg once daily on Days 1 through 21 of each 28 day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.

Treatment: Drugs: Melphalan
Double-blind Induction: the starting melphalan oral dosing regimen in all 3 treatment arms was 0.18 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.

Treatment: Drugs: Prednisone
Double-blind induction: the starting prednisone oral dosing regimen in all 3 treatment arms was 2 mg/kg daily on Days 1 through 4 of each 28-day cycle for up to 9 cycles. Dose was reduced if needed due to dose-limiting toxicity.

Treatment: Drugs: Aspirin
Double-blind induction: low-dose aspirin 75 mg to 100 mg daily for all treatment arms.
Double-blind maintenance: at the investigator's discretion

Treatment: Drugs: Placebo
Double-blind induction: participants in treatment arm MPp+p received placebo once daily on Days 1 through 21 of each 28-day cycle for up to 9 cycles.
Double-blind maintenance: participants in treatment arms MPR+p and MPp+p received placebo once daily on Days 1 through 21 of each 28-day cycle from cycle 10 to disease progression.

Treatment: Drugs: Lenalidomide: Double-blind Maintenance
Single-agent oral lenalidomide 10 mg once daily on Days 1 through 21 of each 28-day cycle from cycle 10 to disease progression.

Treatment: Drugs: Lenalidomide: Open-label
Any study participant who had progressive disease had the option of open-label lenalidomide up to 25 mg daily on Days 1 through 21 of each 28-day cycle.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC) - 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.
Timepoint [1] 0 0
up to 165 weeks
Secondary outcome [1] 0 0
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) - 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.
Timepoint [1] 0 0
Approximately week 37 (start of cycle 10) to week 165
Secondary outcome [2] 0 0
Kaplan Meier Estimates of Overall Survival (OS) - 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.
Timepoint [2] 0 0
up to 177 weeks
Secondary outcome [3] 0 0
Kaplan Meier Estimates of Time to Progression (TTP) Based on the Response Assessment by the Central Adjudication Committee (CAC) - 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.
Timepoint [3] 0 0
up to 165 weeks
Secondary outcome [4] 0 0
Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period - 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).
Timepoint [4] 0 0
Up to 165 weeks
Secondary outcome [5] 0 0
Time to First Response - 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.
Timepoint [5] 0 0
Up to 66 weeks
Secondary outcome [6] 0 0
Kaplan Meier Estimates for Duration of Response as Determined by the Central Adjudication Committee (CAC) - 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.
Timepoint [6] 0 0
Up to 149 weeks
Secondary outcome [7] 0 0
Kaplan Meier Estimates for Time to Next Antimyeloma Therapy - 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.
Timepoint [7] 0 0
Up to 168 weeks
Secondary outcome [8] 0 0
Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period - 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.
Timepoint [8] 0 0
Up to 169 weeks (Double-blind therapy period plus 4 weeks)
Secondary outcome [9] 0 0
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 - 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.
Timepoint [9] 0 0
Baseline (Day 0), Months 4, 7, 10, 13, 16
Secondary outcome [10] 0 0
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 - 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.
Timepoint [10] 0 0
Baseline (Day 0), Months 4, 7, 10, 13, 16
Secondary outcome [11] 0 0
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 - 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.
Timepoint [11] 0 0
Baseline (Day 0), Months 4, 7, 10, 13, 16
Secondary outcome [12] 0 0
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 - 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.
Timepoint [12] 0 0
Baseline (Day 0), Months 4, 7, 10, 13, 16
Secondary outcome [13] 0 0
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 - 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.
Timepoint [13] 0 0
Baseline (Day 0), Months 4, 7, 10, 13, 16
Secondary outcome [14] 0 0
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 - 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.
Timepoint [14] 0 0
Baseline (Day 0), Months 4, 7, 10, 13, 16
Secondary outcome [15] 0 0
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 - 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.
Timepoint [15] 0 0
Baseline (Day 0), Months 4, 7, 10, 13, 16
Secondary outcome [16] 0 0
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 - 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.
Timepoint [16] 0 0
Baseline (Day 0), Months 4, 7, 10, 13, 16
Secondary outcome [17] 0 0
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 - 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.
Timepoint [17] 0 0
Baseline (Day 0), Months 4, 7, 10, 13, 16
Secondary outcome [18] 0 0
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 - 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.
Timepoint [18] 0 0
Baseline (Day 0), Months 4, 7, 10, 13, 16
Secondary outcome [19] 0 0
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 - 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.
Timepoint [19] 0 0
Baseline (Day 0), Months 4, 7, 10, 13, 16
Secondary outcome [20] 0 0
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 - 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.
Timepoint [20] 0 0
Baseline (Day 0), Months 4, 7, 10, 13, 16
Secondary outcome [21] 0 0
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 - 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.
Timepoint [21] 0 0
Baseline (Day 0), Months 4, 7, 10, 13, 16
Secondary outcome [22] 0 0
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 - 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.
Timepoint [22] 0 0
Baseline (Day 0), Months 4, 7, 10, 13, 16
Secondary outcome [23] 0 0
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 - 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.
Timepoint [23] 0 0
Baseline (Day 0), Months 4, 7, 10, 13, 16
Secondary outcome [24] 0 0
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 - 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.
Timepoint [24] 0 0
Baseline (Day 0), Months 4, 7, 10, 13, 16
Secondary outcome [25] 0 0
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 - 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.
Timepoint [25] 0 0
Baseline (Day 0), Months 4, 7, 10, 13, 16
Secondary outcome [26] 0 0
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 - 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.
Timepoint [26] 0 0
Baseline (Day 0), Months 4, 7, 10, 13, 16
Secondary outcome [27] 0 0
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 - 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.
Timepoint [27] 0 0
Baseline (Day 0), Months 4, 7, 10, 13, 16

Eligibility
Key inclusion criteria
Inclusion Criteria

1. Must understand and voluntarily sign an informed consent form

2. Age greater than or equal to 65 years at the time of signing the informed consent

3. Newly diagnosed with symptomatic multiple myeloma as defined by the 3 criteria below:

MM diagnostic criteria (all of next 3 required)

1. Monoclonal plasma cells in the bone marrow greater than or equal to 10% and/or
presence of a biopsy-proven plasmacytoma

2. Monoclonal protein present in the serum and/or urine

3. Myeloma-related organ dysfunction (at least one of the following) [C] Calcium
elevation in the blood (serum calcium >10.5mg/dl or upper limit of normal) [R] Renal
insufficiency (serum creatinine >2mg/dl) [A] Anemia (hemoglobin <10g/dl or 2g <
normal) [B] Lytic bone lesions or osteoporosis AND have measurable disease as defined
by the following; IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level
greater than or equal to 1.0 g/dL or urine M-protein level greater than or equal to
200 mg/24 hours IgA multiple myeloma: Serum M-protein level greater than or equal to
0.5 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours IgD
multiple myeloma: Serum M-protein level greater than or equal to 0.05 g/dL or urine
M-protein level greater than or equal to 200 mg/24 hours Light chain multiple myeloma:
Serum M-protein level greater than or equal to 1.0 g/dL or urine M-protein level
greater than or equal to 200 mg/24 hours IgM multiple myeloma (IgM M-protein plus
lytic bone disease documented by skeletal survey plain films): Serum M-protein level
greater than or equal to 1.0g/dL or urine M-protein level greater than or equal to
200mg/24hours

4. Karnofsky performance status greater than or equal to 60%.

5. Able to adhere to the study visit schedule and other protocol requirements.

6. Women of Childbearing potential (WCBP) must:

a. Have a negative medically supervised pregnancy test prior to the start of study
therapy. She must agree to ongoing pregnancy testing during the course of the study,
and after end of study therapy. This applies even if the subject practices and
continues sexual abstinence.

b Either commit to 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 dose interruptions), and for 28 days after discontinuation of
study therapy.

7. Males Subjects must:

1. Agree to use a condom during sexual contact with a WCBP, even if they have had a
vasectomy, throughout study drug therapy, during any dose interruption and after
the cessation of study therapy.

2. Agree to not donate semen during study drug therapy and for a period after end of
study drug therapy.

8. All subjects must

1. Have an understanding that the study drug could have 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.

4. All patients must be counseled about pregnancy precautions and risks of fetal
exposure.

Female Subjects:

Females of childbearing potential (FCBP) with regular cycles must agree to have pregnancy
tests weekly for the first 28 days of study participation and then every 28 days while on
study, at study discontinuation, and at day 28 following discontinuation from the study. If
menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28
days and then every 14 days while on study, at study discontinuation, and at days 14 and 28
following discontinuation from the study.

In addition to the required pregnancy testing, the Investigator must confirm with FCBP that
she is continuing to use two reliable methods of birth control at each visit. Counseling
about pregnancy precautions and the potential risks of fetal exposure must be conducted at
a minimum of every 28 days. During counseling, subjects must be reminded to not share study
drug and to not donate blood.

Pregnancy testing and counseling must be performed if a subject misses her period or if her
pregnancy test or her menstrual bleeding is abnormal. Study drug treatment must be
discontinued during this evaluation.

Females must agree to abstain from breastfeeding during study participation and for at
least 28 days after the discontinuation from the study.

Male Subjects:

Counseling about the requirement for latex condom use during sexual contact with females of
childbearing potential and the potential risks of fetal exposure must be conducted at a
minimum of every 28 days. During counseling, subjects must be reminded to not share study
drug and to not donate blood, sperm, or semen.

If pregnancy or a positive pregnancy test does occur in a study subject or the partner of a
study subject during study participation, study drug must be immediately discontinued.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. Previous treatment with antimyeloma 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 28 days [4 weeks] of randomization]).

2. Any serious medical condition, including the presence of laboratory abnormalities,
which places the subject at an unacceptable risk if he or she participates in this
study or confounds experimental the ability to interpret data from the study.

3. Pregnant or lactating females.

4. Radiotherapy within 14 days (2 weeks) of randomization.

5. Plasmapheresis within 28 days (4 weeks) of randomization.

6. Any of the following laboratory abnormalities:

Absolute neutrophil count (ANC) < 1,500 cells/mL (1.5*10^9/L) Platelet count < 75,000
cells/uL (75*10^9/L) for subjects in whom < 50% of bone marrow nucleated cells are
plasma cells; but platelet count <30,000/uL for subjects in whom >= 50% of bone marrow
nucleated cells are plasma cells Haemoglobin < 8.0 g/dL (80 g/L) Serum creatinine >
2.5 mg/dL (221 µmol/L) Serum aspartate aminotransferase (SGOT/AST) or alanine
aminotransferase (SGPT/ALT) > 3.0 times upper limit of normal (ULN)

7. Prior history of malignancies, other than multiple myeloma, unless the subject has
been free of the disease for greater than or equal to 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 histologic finding of
prostate cancer (TNM Classification of Malignant Tumours (TNM) stage of T1a or T1b)

8. Neuropathy of >= grade 2 severity.

9. Known human immunodeficiency virus (HIV) positivity or active infectious hepatitis,
type A, B or C.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Hematology Oncology Clinics of Australia, Level 5, Mater Medical Centre - South Brisbane
Recruitment hospital [2] 0 0
Royal Adelaide Hospital Institute of Medical and Veterinary Science - Adelaide
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology - East Melbourne
Recruitment hospital [5] 0 0
Frankston Hospital - Frankston
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
3006 - East Melbourne
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3141 - Melbourne
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Innsbruck
Country [2] 0 0
Austria
State/province [2] 0 0
Salzburg
Country [3] 0 0
Austria
State/province [3] 0 0
Vienna
Country [4] 0 0
Belarus
State/province [4] 0 0
Gomel
Country [5] 0 0
Belarus
State/province [5] 0 0
Minsk
Country [6] 0 0
Belgium
State/province [6] 0 0
Brugge
Country [7] 0 0
Belgium
State/province [7] 0 0
Brussels
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Belgium
State/province [9] 0 0
Liege
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Brno
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Hradec Kralove
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Olomouc
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Prague
Country [14] 0 0
Denmark
State/province [14] 0 0
Aalborg
Country [15] 0 0
Denmark
State/province [15] 0 0
Vejle
Country [16] 0 0
France
State/province [16] 0 0
Caen
Country [17] 0 0
France
State/province [17] 0 0
Limoges Cedex 1
Country [18] 0 0
France
State/province [18] 0 0
Montpellier Cedex 5
Country [19] 0 0
France
State/province [19] 0 0
Paris
Country [20] 0 0
France
State/province [20] 0 0
Toulouse cedex 9
Country [21] 0 0
Georgia
State/province [21] 0 0
Tbilisi
Country [22] 0 0
Germany
State/province [22] 0 0
Berlin
Country [23] 0 0
Germany
State/province [23] 0 0
Dresden
Country [24] 0 0
Germany
State/province [24] 0 0
Freiburg
Country [25] 0 0
Germany
State/province [25] 0 0
Greifswald
Country [26] 0 0
Germany
State/province [26] 0 0
Heidelberg
Country [27] 0 0
Germany
State/province [27] 0 0
Leipzig
Country [28] 0 0
Germany
State/province [28] 0 0
Münster
Country [29] 0 0
Germany
State/province [29] 0 0
Tübingen
Country [30] 0 0
Germany
State/province [30] 0 0
Ulm
Country [31] 0 0
Germany
State/province [31] 0 0
Würzburg
Country [32] 0 0
Greece
State/province [32] 0 0
Athens
Country [33] 0 0
Ireland
State/province [33] 0 0
Dublin
Country [34] 0 0
Ireland
State/province [34] 0 0
Tullamore / Co Offally
Country [35] 0 0
Israel
State/province [35] 0 0
Haifa
Country [36] 0 0
Israel
State/province [36] 0 0
Jerusalem
Country [37] 0 0
Israel
State/province [37] 0 0
Petch Tikva
Country [38] 0 0
Israel
State/province [38] 0 0
Tel Hashomer
Country [39] 0 0
Italy
State/province [39] 0 0
Bologna
Country [40] 0 0
Italy
State/province [40] 0 0
Genova
Country [41] 0 0
Italy
State/province [41] 0 0
Milano
Country [42] 0 0
Italy
State/province [42] 0 0
Pavia 2
Country [43] 0 0
Italy
State/province [43] 0 0
Rome
Country [44] 0 0
Italy
State/province [44] 0 0
San Giovanni Rotondo (FG)
Country [45] 0 0
Italy
State/province [45] 0 0
Turin
Country [46] 0 0
Netherlands
State/province [46] 0 0
Amsterdam
Country [47] 0 0
Netherlands
State/province [47] 0 0
Rotterdam
Country [48] 0 0
Netherlands
State/province [48] 0 0
Utrecht
Country [49] 0 0
Poland
State/province [49] 0 0
Bialystok
Country [50] 0 0
Poland
State/province [50] 0 0
Gdansk
Country [51] 0 0
Poland
State/province [51] 0 0
Krakow
Country [52] 0 0
Poland
State/province [52] 0 0
Lodz
Country [53] 0 0
Poland
State/province [53] 0 0
Lublin
Country [54] 0 0
Poland
State/province [54] 0 0
Warsaw
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Moscow
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Novosibirsk
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Obninsk
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Samara
Country [59] 0 0
Russian Federation
State/province [59] 0 0
St. Petersburg
Country [60] 0 0
Spain
State/province [60] 0 0
Barcelona
Country [61] 0 0
Spain
State/province [61] 0 0
Cadiz
Country [62] 0 0
Spain
State/province [62] 0 0
Madrid
Country [63] 0 0
Spain
State/province [63] 0 0
Salamanca
Country [64] 0 0
Spain
State/province [64] 0 0
Sevilla
Country [65] 0 0
Sweden
State/province [65] 0 0
Boras
Country [66] 0 0
Sweden
State/province [66] 0 0
Malmö
Country [67] 0 0
Switzerland
State/province [67] 0 0
Zurich
Country [68] 0 0
Turkey
State/province [68] 0 0
Ankara
Country [69] 0 0
Turkey
State/province [69] 0 0
Istanbul
Country [70] 0 0
Turkey
State/province [70] 0 0
Izmir
Country [71] 0 0
Ukraine
State/province [71] 0 0
Cherkassy
Country [72] 0 0
Ukraine
State/province [72] 0 0
Dnepropetrovsk
Country [73] 0 0
Ukraine
State/province [73] 0 0
Donetsk
Country [74] 0 0
Ukraine
State/province [74] 0 0
Kiev
Country [75] 0 0
Ukraine
State/province [75] 0 0
Lviv 79044
Country [76] 0 0
Ukraine
State/province [76] 0 0
Zhitomir
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Aidrie
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Leeds
Country [79] 0 0
United Kingdom
State/province [79] 0 0
London
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Celgene Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00405756
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Antonio Palumbo, M.D.
Address 0 0
Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications