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NCT04009109: Phase 2 - Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in TIE NDMM

Updated: Sep 8, 2022

NCT04009109: Phase 2 - Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM

TIE-NDMM

Lenalidomide Ixazomib Daratumumab

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.


Sponsor

Alliance Foundation Trials, LLC


Collaborators</