Treatment for Elderly Fit Newly Diagnosed Multiple Myeloma Patients Aged Between 65 and 80 Years
Status:
Recruiting
Trial end date:
2031-10-22
Target enrollment:
Participant gender:
Summary
The study is designed as a randomized, controlled, open-label, assessor blind, multicenter
superiority trial with three parallel groups, and primary endpoint of immunophenotypic
complete responses at 18 months after randomization. Block randomization will be performed
with a 1:1:1 allocation ratio.
Patients will be randomized up front to 3 arms. Patients will receive "standard" PETHEMA arm
for fit elderly VMP x 9 + Rd x 9 (arm 1, control arm), a KRd regimen (arm 2a) (18 cycles) or
a Carfilzomib-lenalidomida-dexametasona regimen combined with DARATUMUMAB (arm 2b) (18
cycles).