Phase 2/3Recruiting
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
Phase 2/3, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Subjects With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
- Sponsor
- AbbVie (Industry)
- Enrollment
- 680 planned
- Conditions
- Multiple Myeloma
- Interventions
- Etentamig; Lenalidomide; Daratumumab; Dexamethasone; Dexamethasone; Etentamig
- Ages
- adults, older adults
- Registry
- NCT07095452, CTIS2025-520897-21-00
Full record on ClinicalTrials.gov
From the registry
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; a phase 2 dose selection and optimization cohort with 3 study arms and a subcutaneous (SC) safety cohort with 2 study arms. Phase 3 participants will receive etentamig at recommended Phase 3 dose (RP3D). Around 680 adult participants with MM will be enrolled at approximately 155 sites worldwide Participants in the phase 2 dose selection and optimization cohort will receive 1 of 3 doses of etentamig as intravenous (IV) infusions, combination with subcutaneous (SC) injections of daratumumab. The Phase 2 subcutaneous (SC) safety cohort participants will receive 1 of 2 doses of etentamig in…
Primary outcomes
- Phase 2 and 3: Percentage of Participants with Adverse Events (AE)s
- Phase 2: Change in Clinical Activity
- Phase 3: Minimal Residual Disease (MRD) Negative CR Rate
- Phase 3: Progression-Free Survival (PFS)
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered