- Active, not recruiting
NCT04009109: Phase 2 - Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in TIE NDMM
Updated: Feb 10
NCT04009109: Phase 2 - Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM
TIE-NDMM
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
Collaborators
Janssen Scientific Affairs, LLC
Celgene Corporation
Takeda
ClinicalTrials.gov Identifier: NCT04009109
Official Title: A Phase II Study of Lenalidomide, Ixazomib, Dexamethasone, and Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma
First Posted : July 5, 2019
Click here for details on ClinicalTrials.gov
Drug: Lenalidomide
Drug: Ixazomib
Drug: Daratumumab Injection
Drug: Dexamethasone
Locations
United States, Maine
United States, Massachusetts
United States, Michigan
United States, Nebraska
United States, North Carolina
United States, Ohio
United States, South Carolina