After enrollment, patients receive 4 cycles of RD, followed by mobilization. Thereafter, on the basis of the initial randomization at enrollment, patients are distributed in two groups, in order to receive either 6 cycles of CRD or MEL-200 ASCT with double transplantation. After consolidation, and always depending on the initial randomization, patients receive maintenance with either R or RP, until any sign of disease progression or intolerance.
STUDY OBJECTIVES:
Primary objectives: - To compare the efficacy of the combination of lenalidomide with low-dose alkylating agents versus high-dose melphalan in newly diagnosed, symptomatic MM patients.
Secondary objectives: - To assess the safety of lenalidomide with low-dose alkylating agents compared to high-dose melphalan in newly diagnosed, symptomatic MM patients
- To assess the prognostic value of risk factor at diagnosis (β2-microglobulin, albumin, C-reactive protein, cytogenetics)
- To assess the efficacy and safety of lenalidomide as maintenance treatment after the consolidation phase
- To assess prognostic significance of stringent remission evaluated by free light chain assay
- To monitor Minimal Residual Disease (MRD) on bone marrow samples and peripheral blood samples in patients achieving at least a VGPR after the consolidation therapy
STUDY POPULATION:
Newly diagnosed multiple myeloma patients who are 65 years of age or younger.
STUDY DRUGS:
Lenalidomide
Dexamethasone
Cyclophosphamide
Prednsione
Melphalan
TOTAL SAMPLE SIZE: 380
ACCRUAL TIME: 24 months
STUDY DURATION: 48 months