Objective of this study is to determine if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple myeloma in younger patients. HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs Progression-free survival (by at least 9 months).
Study design Phase III, multicenter, randomized, open-label study designed to evaluate the clinical benefit from the drug combination RVD without immediate high-dose therapy (HDT) followed by lenalidomide maintenance (Arm A) versus RVD plus HDT and PBSCT followed by lenalidomide maintenance (Arm B).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
700
Lenalidomide/Bortézomib/Dexamethasone cycles: Number of cycles: 8 cycles for arm A Cycle length Dosage: * Lenalidomide: 25 mg/day on days 1-14 of each cycle * Bortézomib: 1.3 mg/m2 on days 1, 4, 8, and 11 for 1 cycle of each cycle Maintenance phase (12 months): Cycle length: 28 days Dosage: Lenalidomide: 10 mg/day continuously for 28 days during 3 months and if the participant tolerates 10 mg/day without complication, a dose increase to 15 mg/day will be allowed
Lenalidomide Bortezomib Dexamethasone cycles: Number of cycles: 5 cycles for arm B Cycle length Dosage: * Lenalidomide: 25 mg/day on days 1-14 of each cycle * Bortézomib: 1.3 mg/m2 on days 1, 4, 8, and 11 for 1 cycle of each cycle Maintenance phase (12 months): Cycle length: 28 days Dosage: Lenalidomide: 10 mg/day continuously for 28 days during 3 months and if the participant tolerates 10 mg/day without complication, a dose increase to 15 mg/day will be allowed
Progression Free Survival
To compare progression-free survival (PFS) between the Arm A and Arm B up to 4 years or until progression
Time frame: up to 4 years
Response Rates
-Response rates (RR) between the two arms up to 4 years or until progression
Time frame: up to 4 years
Time To Progression
Time to progression (TTP) between the two arms up to 4 years or until progression
Time frame: up to 4 years
Toxicity comparison
Toxicity comparison between the two arms randomization up to 4 years or until progression
Time frame: up to 4 years
Genetic prognostic groups definition
Genetic prognostic groups definition (evaluated by gene expression profiling-GEP) from randomization up to 4 years or until progression
Time frame: up to 4 years
Best treatment examination in each GEP-defined prognostic group.
Best treatment examination in each GEP-defined prognostic group. from randomization up to 4 years or until progression
Time frame: up to 4 years
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CH du Pays D'Aix
Aix-en-Provence, France
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Amiens, France
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Angers, France
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Argenteuil, France
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Bayonne, France
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