What is the Purpose of this Study?
The purpose of this study is to evaluate the safety of a drug called etentamig and identify the optimal dose of the drug when combined with another drug, daratumumab, in people with newly diagnosed multiple myeloma (NDMM) who are not eligible for transplant. Researchers will monitor the effect of etentamig on the patient’s cancer. Etentamig is a bispecific antibody, and daratumumab is a monoclonal antibody (proteins made in a lab that are designed to help the immune system kill cancer cells). Participants will be randomly assigned to 1 of 3 treatment dose groups of etentamig in combination with daratumumab. Once the optimal dose is found, participants will be randomly assigned to receive either etentamig with daratumumab (Etentamig + D), or standard-of-care treatment approved by the U.S. Food and Drug Administration (FDA) combining daratumumab, lenalidomide, and dexamethasone (DRd). Study procedures also include exams, electrocardiograms, blood draws, imaging, and biopsy. The use of etentamig and daratumumab in this study is investigational.
Eligibility
- * Participants must have confirmed new diagnosis of multiple myeloma (NDMM) according to the International Myeloma Working Group (IMWG) diagnostic criteria, and per investigator's judgement, participant is not suitable to receive high-dose chemotherapy and stem cell transplantation due to factors likely to have a negative impact on tolerability of high dose chemotherapy and autologous stem cell transplants (ASCT).
- * IMWG Myeloma Frailty Index Score of \>= 1
- * All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment:
Where can I participate?
CS Cancer at Cedars-Sinai Medical Center : Emilie Douine-Barthelemy
More about this Clinical Trial
What is the full name of this clinical trial?
M25-586: A Phase 2/3, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Etentamig and Daratumumab Compared to Daratumumab, Lenalidomide, and Dexamethasone in Subjects with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant