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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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)
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)
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)
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
Timepoint [4] 0 0
Up to 165 weeks
Secondary outcome [5] 0 0
Time to First Response
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)
Timepoint [6] 0 0
Up to 149 weeks
Secondary outcome [7] 0 0
Kaplan Meier Estimates for Time to Next Antimyeloma 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Sex
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
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2016
Sample size
Target
Accrual to date
Final
459
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/study/NCT00405756
Trial related presentations / publications
Dimopoulos MA, Delforge M, Hajek R, Kropff M, Petrucci MT, Lewis P, Nixon A, Zhang J, Mei J, Palumbo A. Lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance, improves health-related quality of life in newly diagnosed multiple myeloma patients aged 65 years or older: results of a randomized phase III trial. Haematologica. 2013 May;98(5):784-8. doi: 10.3324/haematol.2012.074534. Epub 2012 Dec 14.
Palumbo A, Hajek R, Delforge M, Kropff M, Petrucci MT, Catalano J, Gisslinger H, Wiktor-Jedrzejczak W, Zodelava M, Weisel K, Cascavilla N, Iosava G, Cavo M, Kloczko J, Blade J, Beksac M, Spicka I, Plesner T, Radke J, Langer C, Ben Yehuda D, Corso A, Herbein L, Yu Z, Mei J, Jacques C, Dimopoulos MA; MM-015 Investigators. Continuous lenalidomide treatment for newly diagnosed multiple myeloma. N Engl J Med. 2012 May 10;366(19):1759-69. doi: 10.1056/NEJMoa1112704. Erratum In: N Engl J Med. 2012 Jul 19;367(3):285.
Dimopoulos MA, Petrucci MT, Foa R, Catalano J, Kropff M, Terpos E, Zhang J, Grote L, Jacques C, Palumbo A; MM-015 Investigators. Impact of maintenance therapy on subsequent treatment in patients with newly diagnosed multiple myeloma: use of "progression-free survival 2" as a clinical trial end-point. Haematologica. 2015 Aug;100(8):e328-30. doi: 10.3324/haematol.2014.120790. Epub 2015 Apr 3. No abstract available.
Public notes

Contacts
Principal investigator
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Antonio Palumbo, M.D.
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Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
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Contact person for public queries
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00405756