Phase 1b Study to Find Safe Doses and Assess Side Effects of Intravenous Etentamig ABBV-383 for Adults With Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Multiple Myeloma MM is a cancer of the bloods plasma cells that often affects bones and bone marrow, causing pain, fractures, infections, weaker bones, and kidney failure. This trial evaluates etentamig ABBV-383, an investigational drug, in adults with relapsed or refractory MM to study adverse events and changes in disease symptoms. The research is conducted in multiple parts and arms to optimize dosing and assess safety in different patient groups. Participants are divided into four arms Arm A has two parts testing step-up dose optimization and dose expansion Arm B tests a flat dose Arms C and D investigate outpatient administration using the step-up dose from Arm A. Treatment involves intravenous infusion of etentamig in 28-day cycles for about three years. Participants include those with varying prior therapies and exposure to BCMA-targeted treatments. During the study, participants attend regular visits at hospitals or clinics for medical assessments, blood tests, side effect checks, and questionnaires. Researchers monitor cytokine release syndrome and other adverse events up to day 28, with extended monitoring for some events up to three years. Around 210 adults will be enrolled globally, with study completion expected by August 2029.

A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma