MagnetisMM6
Research type
Research Study
Full title
An Open-Label, 2-Arm, Multicenter, Randomized Phase 3 Study To Evaluate The Efficacy And Safety of Elranatamab (PF-06863135) + Daratumumab + Lenalidomide Versus Daratumumab + Lenalidomide + Dexamethasone in Transplant-Ineligible Participants With Newly-Diagnosed Multiple Myeloma
IRAS ID
1007002
Contact name
Andy Blake-Haskins
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2021-000803-20
Clinicaltrials.gov Identifier
Research summary
The main purpose of this study is to evaluate if the combination of elranatamab, daratumumab, and lenalidomide (EDR) offers superior clinical benefit compared with the combination of daratumumab, lenalidomide, and dexamethasone (DRd) in people with newly diagnosed multiple myeloma (NDMM) that is transplant-ineligible. This is a global, multicenter study.
There are 2 parts to this study. Part 1 will evaluate EDR in relapsed/refractory multiple myeloma and NDMM that is transplant-ineligible. The main purpose of Part 1 is to characterize the safety and tolerability of combination therapy EDR and identify the optimal doses of the combination regimen to be used in Part 2. The main purpose of Part 2 of the study is to evaluate the safety and efficacy of EDR when compared with DRd in participants with NDMM that is transplant-ineligible. .
The study will also look at the amount of study drug in the blood and how it is changed and removed from the body (pharmacokinetics) as well as the impact of treatment on the patient quality of life. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic for about 5 years. Pfizer, Inc is funding the study. The UK will participate in Part 2 of this studyREC name
East Midlands - Leicester South Research Ethics Committee
REC reference
23/EM/0141
Date of REC Opinion
31 Aug 2023
REC opinion
Further Information Favourable Opinion