After enrollment, patients are randomized to receive cycles either of POM-DEX or of POM-CYCLO-DEX, until any sign of disease progression or intolerance. The beginning of treatment depends on a different randomization between EARLY or LATE TREATMENT, on which basis patients start the therapy as soon as biochemical relapse or CRAB symptoms occur.
STUDY OBJECTIVES:
Primary objectives: - Compare the efficacy of pom-dex versus pom-cyclo-dex in terms of OS
- Evaluate the best treatment strategy (EARLY TREATMENT at biochemical relapse versus LATE TREATMENT at onset of CRAB symptoms/significant paraprotein increase) in terms of OS
Secondary objectives: - Compare the best therapy, pom-dex vs pom-cyclo-dex in terms of PFS and PFS2
- Compare the best strategy, EARLY TREATMENT versus LATE TREATMENT, in terms of PFS2
- Evaluate quality of life (QoL) and health related costs in the two therapies, pom-dex versus pom-cyclo-dex, and in the two strategies, EARLY TREATMENT versus LATE TREATMENT
- Explore the presence of clinically meaningful interactions between therapies and strategies
- Determine whether tumor response, PFS, PFS2 and OS might significantly change in particular subgroups of patients defined by prognostic factors (such as International Staging System, chromosomal abnormalities) and by performance status
- Evaluate the safety and tolerability of the strategy and of the combination pom-dex and pom-cyclo-dex
STUDY POPULATION:
Multiple myeloma patients at the first biochemical relapse
STUDY DRUGS:
Pomalidomide
Dexamethasone
Cyclophosphamide
TOTAL SAMPLE SIZE: 260
ACCRUAL TIME: 36 months
STUDY DURATION: 60 months