Clinical Trial

Treatment for Elderly Fit Newly Diagnosed Multiple Myeloma Patients Aged Between 65 and 80 Years

Active, Not Recruiting Phase 3
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Record status
This record was last updated September 14, 2022 (before its estimated July 2023 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2018-11-13; most recent amendment 2022-09-13.
Status change: Recruiting → Active, Not Recruiting 2022-09-13
Trial Details
NCT Number NCT03742297
Lead Sponsor PETHEMA Foundation
Conditions Newly Diagnosed Multiple Myeloma
Enrollment 462 participants
Start Date 2018-10-22
Primary Completion 2023-07 (estimated)
Study Completion 2031-01 (estimated)
Updated on ClinicalTrials.gov 2022-09-14