NCT05558319: Phase 3: (GEM21menos65) Extended VRD Plus vs Isa-VRD vs Isa-V-Iberdomide - NDMM - ASCT

(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

PETHEMA Foundation

Collaborators

Bristol-Myers Squibb

Sanofi

Adknoma

Start from scratch

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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

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Dexamethasone : National Cancer Institute

Isatuximab : National Cancer Institute

Iberdomide: National Cancer Institute

Dexamethasone : National Cancer Institute

Bortezomib : National Cancer Institute

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Drug: Bortezomib

Drug: Isatuximab

Drug: Iberdomide

Drug: Lenalidomide

Drug: Dexamethasone

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Locations

Spain