After enrollment, patients receive 4 cycles of PCD, followed by ASCT for patients who had not received PCD as first-line treatment. ASCT is followed by 4 consolidation cycles of PCD. The patients who already underwent ASCT proceed with PCD consolidation. Thereafter, all patients are randomized to receive maintenance therapy, with either P or PD, until any sign of disease progression or intolerance.
STUDY OBJECTIVES:
Primary objectives: - Evaluate the efficacy, defined as PFS, of pomalidomide maintenance plus dexamethasone versus pomalidomide maintenance in patients who responded (≥ PR) to the combination of pomalidomide (POM), carfilzomib (CAR) and low dose dexamethasone (LD-DEX) for induction and consolidation
- Evaluate efficacy defined as response rate (sCR, CR, VGPR, PR) of the combination of pomalidomide (POM), carfilzomib (CAR) and low dose dexamethasone (LD-DEX) for induction and consolidation in subjects with relapsed or refractory multiple myeloma (MM) after prior first-line treatment in the EMN02/HO95 trial who are refractory to Lenalidomide and/or Bortezomib. This objective will be investigated in patients who have or have not received a prior autologous transplant.
Secondary objectives: - Evaluate the response rate after 8 cycles of PCd before the start of maintenance.
- Evaluate the safety and tolerability of the combination of pomalidomide, carfilzomib and low dose dexamethasone in subjects with relapsed or refractory multiple myeloma.
STUDY POPULATION:
Patients with symptomatic Multiple Myeloma who have a first progression on or after treatment in the EMN02/HO95 trial or who are refractory to lenalidomide and/or bortezomib.
STUDY DRUGS:
Carfilzomib
Pomalidomide
Dexamethason
Melphalan
TOTAL SAMPLE SIZE: 222
ACCRUAL TIME: 24 months