Clinical Trial

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

Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2019-07-02; most recent amendment 2025-12-16.
Status change: Recruiting → Active, Not Recruiting 2024-02-02
Status change: Not Yet Recruiting → Recruiting 2021-03-18
Trial Details
NCT Number NCT04009109
Lead Sponsor Alliance Foundation Trials, LLC.
Collaborators: Janssen Scientific Affairs, LLC, Celgene Corporation, Takeda
Conditions Myeloma, Multiple
Enrollment 79 participants
Start Date 2020-10-21
Primary Completion 2026-12 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2025-12-18