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 MPR or MEL-200-ASCT with double transplantation. After consolidation and always depending on the initial randomization, patients receive maintenance with R alone or no maintenance, until any sign of disease progression or intolerance.
STUDY OBJECTIVES:
Primary objectives: - To compare the efficacy of the combination of lenalidomide with low-dose melphalan versus high-dose melphalan in newly diagnosed, symptomatic MM patients
Secondary objectives: - To evaluate whether induction treatment with lenalidomide compromises subsequent mobilization of peripheral blood stem cells (PBSC)
- To assess the safety of lenalidomide in combination with low-dose melphalan compared to high-dose melphalan in newly diagnosed, symptomatic MM patients
- To assess the efficacy and safety of lenalidomide as maintenance treatment after the consolidation phase
STUDY POPULATION:
Newly diagnosed MM patients who are 65 years of age or younger
STUDY DRUGS:
Lenalidomide
Dexamethasone
Cyclophosphamide
Prednsione
Melphalan
TOTAL SAMPLE SIZE: 400
ACCRUAL TIME: 24 months
STUDY DURATION: 48 months