A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Launched by ABBVIE · Jul 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for adults who have recently been diagnosed with multiple myeloma, a type of blood cancer that affects the bones and bone marrow. The trial is comparing a combination of an investigational drug called etentamig plus daratumumab (a medication already used in myeloma) to a standard treatment that includes daratumumab, lenalidomide, and dexamethasone (often called DRd). The main goals are to see how well the treatments control the disease and to understand the side effects participants might experience.

People who may be eligible for this study are adults with newly diagnosed multiple myeloma who are not able to have a stem cell transplant because of other health concerns or frailty. Participants need to have measurable disease based on specific blood or urine tests. If accepted, participants will receive the study medications through infusions or pills and will visit the clinic regularly for check-ups, blood tests, and to discuss any side effects. The study will last for several years and involves many visits, so participants should be prepared for a higher level of monitoring than usual care. This trial is currently not yet recruiting.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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:
• • Serum M-protein \>= 0.5 g/dL (\>= 5 g/L).
• • Urine M-protein \>= 200 mg/24 hours.
• • Serum free light chain (FLC) \>= 100 mg/L (\>= 10 mg/dL) (involved light chain) and an abnormal serum kappa lambda ratio only for participants without measurable serum or urine M-protein.
• Exclusion Criteria:
• • Prior or current systemic therapy or stem cell transplant (SCT) for multiple myeloma or any plasma cell dyscrasia other than short course of corticosteroids
• • Participant treated with any investigational treatment within 30 days or 5 half-lives of the treatment (whichever is longer) prior to the first dose of study treatment or is currently enrolled in another clinical study
• • Participant who has known active central nervous system involvement of MM.
• • Participant who has history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, pulmonary, or hepatic disease within the last 6 months that, in the investigator's opinion, would adversely affect the participant's participation in the study.