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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
EU CTIS ID: 2025-520897-21-00
What this study is testing
Phase 2: To determine the RP3D of etentamig in combination with daratumumab in partcipants with Newly Diagnosed Multiple Myeloma (NDMM) that are not eligible for transplant Phase 3: To evaluate the efficacy of etentamig administered with daratumumab in participants with NDMM that are not eligible for transplant To evaluate the efficacy of etentamig administered with daratumumab in participants with NDMM that are not eligible for transplant
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must have confirmed NDMM according to the 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 ASCT.
- International Myeloma Working Group (IMWG) Myeloma Frailty Index Score of ≥ 1
- Eastern Cooperative Oncology Group (ECOG) performance 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.
You likely can't join if
- Prior or current systemic therapy or SCT for multiple myeloma or any plasma cell dyscrasia other than short course of corticosteroids
- Participants received treatment with anti-cancer therapy (including chemotherapy, radiotherapy, biologics, immunotherapy, cellular therapies and/or steroids at doses > 20 mg dexamethasone or equivalent) or undergone a major surgical procedure within 21 days or within 5 half-lives of an anticancer therapy, prior to the first dose of study treatment, whichever is shorter
- 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 Multiple Myeloma (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
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.