Phase 23 Study of Intravenous Etentamig and Daratumumab Versus Daratumumab, Lenalidomide, and Dexamethasone in Adults with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

What this Trial Is About

Multiple myeloma MM is a cancer affecting plasma cells in the blood, often found in bones and bone marrow. It can cause bone pain, fractures, infections, weaker bones, and kidney failure. Researchers are studying the investigational drug Etentamig to understand its side effects, impact on disease activity, and how it behaves in the body for adults with MM. This study is conducted in two phases, phase 2 and phase 3, involving about 660 adult participants worldwide who have newly diagnosed MM and are not eligible for transplant. In phase 2, participants receive one of three doses of Etentamig combined with daratumumab in phase 3, participants receive the recommended phase 3 dose RP3D of Etentamig with daratumumab or a combination of daratumumab, lenalidomide, and dexamethasone DRd. Etentamig is given as intravenous infusions, daratumumab as subcutaneous injections, lenalidomide as capsules, and dexamethasone as oral tablets or intravenous injections. The study lasts approximately 16 years, with treatments continuing until the recommended dose is reached or as part of the study duration. Participants will attend regular hospital or clinic visits where their response to treatment will be monitored through medical exams, blood tests, side effect checks, and questionnaires. Researchers will measure outcomes like adverse events, disease activity changes, minimal residual disease rates, progression-free survival, and overall survival over up to 16 years. The study aims to assess both safety and disease control with ongoing monitoring and evaluations throughout the long study period.

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