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A Phase II Study of Lenalidomide, Ixazomib, Dexamethasone, and Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma
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.
Details
| Lead sponsor | Alliance Foundation Trials, LLC. |
|---|---|
| Phase | Phase 2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 79 |
| Start date | 2020-10-21 |
| Completion | 2027-06 |
Conditions
- Myeloma, Multiple
Interventions
- Lenalidomide
- Ixazomib
- Daratumumab Injection
- Dexamethasone
Primary outcomes
- Impact of Study Treatment on Progression Free Survival (PFS) — 5 Years
Time interval between registration and progression or death.
Countries
United States