- Not yet recruiting
NCT05558319: Phase 3: (GEM21menos65) Extended VRD Plus vs Isa-VRD vs Isa-V-Iberdomide - NDMM - ASCT
Updated: Feb 4
(GEM21menos65)
(Isatuximab-VRD + ASCT) - (VRD extended + ASCT plus ERI) - (Isatuximab-VID + ASCT).
ERI=Early Rescue Intervention
NCT05558319: Phase 3: NDMM Patients Candidates for ASCT Comparing Extended VRD Plus vs. Isa-VRD vs. Isa-V-Iberdomide (GEM21menos65)
NCT05558319: Phase 3: NDMM Patients Candidates for ASCT Comparing Extended VRD Plus vs. Isa-VRD vs. Isa-V-Iberdomide (GEM21menos65)
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.
Sponsor
Collaborators
Start from scratch
ClinicalTrials.gov Identifier: NCT05558319
Official Title: GEM21menos65. A Phase III Trial for NDMM Patients Who Are Candidates for ASCT Comparing Extended VRD Plus Early Rescue Intervention vs Isatuximab-VRD vs Isatuximab-V-Iberdomide-D
First Posted : September 28, 2022
Click here to see details on ClinicalTrials.gov
Drug: Bortezomib
Drug: Isatuximab
Drug: Iberdomide
Drug: Lenalidomide
Drug: Dexamethasone
Locations
Spain