After enrollment, the mobilization phase begins. Subsequently, patients receive MEL100 followed by stem-cell infusion. Thereafter, follows a further consolidation phase with RP, and then maintenance with R alone, until any sign of disease progression or intolerance.
STUDY OBJECTIVES:
Primary objectives: - Determine whether the sequence MEL100-Revlimid and Prednisone (RP) is safe and provides benefits in patients with newly diagnosed myeloma.
Secondary objectives: - Determine the overall survival(OS).
- A progression-free survival (PFS) at 3 years is > 35%
- Verify whether molecular remissions obtained with the sequence PAD-MEL100 are transient or persistent.
- Verify whether molecular remissions obtained with the proposed treatment are associated with a prolongation of progression-free survival.
- Determine whether tumor response and survival might significantly change in particular subgroups of patients defined on prognostic factors (b2-microglobulin, Creactive protein, cytogenetics, gene expression profile).
STUDY POPULATION:
Newly diagnosed multiple myeloma patients eligible for high dose therapy.
STUDY DRUGS:
Lenalidomide
Prednsione
Melphalan
TOTAL SAMPLE SIZE: 100
ACCRUAL TIME: 24 months
STUDY DURATION: 60 months