Overview

Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM

Status:
Recruiting
Trial end date:
2025-07-31
Target enrollment:
Participant gender:
Summary
A randomized Phase II clinical trial will be conducted to assess the impact on progression free survival (PFS) with the addition of ixazomib and daratumumab to lenalidomide as a maintenance treatment following induction with lenalidomide, ixazomib, dexamethasone, and daratumumab. Patients will be randomized to either: Arm A: 12 cycles of lenalidomide, ixazomib, daratumumab, and dexamethasone followed by lenalidomide until disease progression or unacceptable toxicity or a maximum of 2 years of maintenance therapy. Arm B: 12 cycles of lenalidomide, ixazomib, daratumumab and dexamethasone, followed by lenalidomide, ixazomib, and daratumumab until disease progression or unacceptable toxicity or a maximum of 2 years maintenance therapy.
Phase:
Phase 2
Details
Lead Sponsor:
Alliance Foundation Trials, LLC.
Collaborators:
Celgene Corporation
Janssen Scientific Affairs, LLC
Takeda
Treatments:
Antibodies, Monoclonal
BB 1101
Daratumumab
Dexamethasone
Dexamethasone acetate
Glycine
Ixazomib
Lenalidomide