This study will evaluate the safety and the efficacy of carfilzomib combined with cyclophosphamide and dexamethasone (CCyd) or lenalidomide and dexamethasone (CRd) followed by autologous transplantation ASCT or 12 cycles of carfilzomib combined with dexamethasone and lenalidomide for patients eligible for ASCT with newly diagnosed multiple myeloma. As a secondary endpoint this study will evaluate the best maintenance treatment between lenalidomide and lenalidomide combined with carfilzomib. Four hundred seventy-seven patients, males and females aged \> 18 years, enrolled in several sites, will take part in this study. The duration of the study is approximately 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
477
IRCCS--CROB --CROB di Rionero in di Rionero in Vulture
Rionero in Vulture, Italy
Efficacy in term of at least Very Good Partial Response (VGPR)
The efficacy, in term of at least VGPR, of the combination of carfilzomib, dexamethasone with cyclophosphamide or lenalidomide after 4 cycles of induction treatment in newly diagnosed MM patients eligible for ASCT.
Time frame: Up to 2 years
sCR rate
the stringent complete response (sCR) rate in the 3 arms after complete primary therapy (induction, ASCT and consolidation for the transplant arms and after 12 cycles in the long treatment arm) in an explorative manner.
Time frame: up to 1 year
Safety as incidence of grade 3/4 adverse events
the safety in the 3 induction/consolidation arms and in the 2 maintenance arms.
Time frame: Up to 3 years
Survival
the survival in the 3 induction/consolidation arms and in the 2 maintenance arms.
Time frame: Up to 5 years
Correlation between tumor response and outcome with baseline prognostic factors.
Time frame: up to 5 years
Minimal Residual Disease (MRD)
Minimal Residual Disease
Time frame: up to 5 years
Survival after relapse
the survival after relapse
Time frame: up to 7 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.