After enrollment, patients receive 4 cycles of VCD, followed by mobilization. Thereafter, patients are randomized for the first time in three groups, in order to receive either 4 cycles of VMP, HDM-1 with single transplantation, or HDM-2 with double transplantation. Thereafter, a second randomization distributes patients in 2 groups, in order to administer 2 cyles of VRD or no consolidation therapy. The last maintenance phase consists of R alone, administered until any sign of disease progression or intolerance.
STUDY OBJECTIVES:
Primary objectives: - Comparison of Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed autologous stem cell transplantation (ASCT)
- Comparison of Bortezomib, Lenalidomide, Dexamethasone (VRD) as consolidation versus no consolidation
- Comparison of single versus tandem high dose Melphalan with ASCT
Secondary objectives: - Response (PR, VGPR, CR and stringent CR), and improvement of response during the various stages of the treatment
- Determine the overall survival (OS) from first and second randomization
- Determine safety
- Determine the quality of life as defined by the EORTC QLQ-C30 and QLQ-MY20 definitions
STUDY POPULATION:
Patients with symptomatic multiple myeloma, previously untreated, ISS stages 1-3, age 18-65 years inclusive
STUDY DRUGS:
Bortezomib
Cyclophosphamide
Dexamethasone
Melphalan
Prednisone
Lenalidomide
TOTAL SAMPLE SIZE: 1500
ACCRUAL TIME: 36 months
STUDY DURATION: 72 months