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- Dec 13, 2019

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

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

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

Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information

Daratumumab and Hyaluronidase-fihj Injection: National Cancer Institute

Daratumumab and Hyaluronidase-fihj Injection: MedlinePlus Drug Information

Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

Ixazomib: National Cancer Institute

Ixazomib: MedlinePlus Drug Information

Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information