Clinical Trial

NDMM Patients Candidates for ASCT Comparing Extended VRD Plus vs. Isa-VRD vs. Isa-V-Iberdomide

Study acronym: GEM21menos65
Recruiting Phase 3
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Summary
This is a Phase III open-label, 3-arm, parallel, randomized, controlled trial. The allocation ratio 1:1:1 and outcome assessment are blind to group allocation. Patients will be randomized from 3 arms. Patients will receive VRD extended + ASCT plus ERI or Isatuximab-VRD + ASCT or Isatuximab-VID + ASCT.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2022-09-23.
Status change: Not Yet Recruiting → Recruiting 2026-06-23
Trial Details
NCT Number NCT05558319
Lead Sponsor PETHEMA Foundation
Collaborators: Bristol-Myers Squibb, Sanofi, Adknoma Health Research
Conditions Newly Diagnosed Multiple Myeloma
Enrollment 480 participants
Start Date 2022-11-10
Primary Completion 2027-04 (estimated)
Study Completion 2029-04 (estimated)
Updated on ClinicalTrials.gov 2026-06-25