OncoMatch/Clinical Trials/NCT07095452
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
Is NCT07095452 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments for multiple myeloma.
Treatment: Etentamig · Lenalidomide · Daratumumab · Dexamethasone · Dexamethasone — Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. This is a study to determine the adverse events, change in disease activity, and pharmacokinetics of Etentamig in adult participants with MM. Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 2 phases; phase 2 with 3 study arms and phase 3 with 2 study arms. Participants in phase 2 will receive 1 of 3 doses of etentamig in combination with daratumumab. Participants in phase 3 will receive etentamig at RP3D in combination with daratumumab, or daratumumab, lenalidomide, and dexamethasone (DRd). Around 660 adult participants with MM will be enrolled at approximately 155 sites worldwide Participants in phase 2 will receive 1 of 3 doses of etentamig as intravenous (IV) infusions, combination with subcutaneous (SC) injections of daratumumab. Participants in phase 3 will receive RP3D doses of etentamig as IV infusions, combination with SC injections of daratumumab, or SC injections of daratumumab, capsules of lenalidomide, and tablet/ IV injections of dexamethasone (DRd). The study duration is approximately 16 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Prior therapy
Cannot have received: systemic therapy
Exception: short course of corticosteroids
Prior or current systemic therapy or stem cell transplant (SCT) for multiple myeloma or any plasma cell dyscrasia other than short course of corticosteroids
Cannot have received: stem cell transplant
Exception: short course of corticosteroids
Prior or current systemic therapy or stem cell transplant (SCT) for multiple myeloma or any plasma cell dyscrasia other than short course of corticosteroids
Cannot have received: investigational treatment
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Colorado Blood Cancer Institute /ID# 279080 · Denver, Colorado
- Fort Wayne Medical Oncology And Hematology /ID# 278141 · Fort Wayne, Indiana
- Minnesota Oncology - Minneapolis Clinic /ID# 278720 · Minneapolis, Minnesota
- Mayo Clinic Hospital Rochester /ID# 277886 · Rochester, Minnesota
- Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 277946 · New York, New York
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