A Study to Evaluate Adverse Events and Change in Disease Activity With Injected Etentamig Plus Oral Pomalidomide Versus Standard Therapies in Adults With Relapsed or Refractory Multiple Myeloma

What this study is about

Multiple myeloma (MM) is a plasma cell malignancy characterized by the proliferation of clonal plasma cells in the bone marrow. The disease primarily localizes to the bones and bone marrow, with resultant cytopenias, bone pain, fractures, infections, hypercalcemia, and renal failure. This study aims to evaluate the safety and change in disease activity of etentamig in combination with pomalidomide compared with standard available therapies in participants with relapsed or refractory multiple myeloma who have received 1-3 prior lines of treatment, including lenalidomide. Etentamig is an investigational drug being developed for the treatment of relapsed or refractory multiple myeloma. This is a randomized, open-label study. The study will include a safety run-in portion and a randomized portion. The safety run-in participants will receive etentamig in combination with pomalidomide. The randomized portion of the study participants will receive either etentamig with pomalidomide or Standard Available Therapies (SATs). Approximately 520 participants will be enrolled in the study at approximately 200 sites worldwide. Prior to initiation of the randomized portion of the study, the safety run-in will be conducted in which participants will receive etentamig injections plus oral pomalidomide. Following review of the safety run-in data and per protocol-defined criteria, the study will advance to the randomized portion where participants will be randomized to receive either etentamig injections plus oral pomalidomide or investigator's choice of SAT: SC daratumumab, oral pomalidomide, and oral/ IV dexamethasone (DPd); SC daratumumab, IV carfilzomib, and oral/IV dexamethasone (DKd); or SC teclistamab monotherapy. The total study duration is approximately 75 months There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Who can join (things the study team will check)

✅ You may be able to join if…

• Diagnosis of relapsed or refractory (RR) multiple myeloma (MM).
• Prior treatment with at least one and no more than three prior lines of therapy, including lenalidomide.
• Adequate organ function and performance status

🚫 You may not be able to join if…

• Prior B-cell maturation antigen (BCMA) directed T-cell engager therapy (bispecific or trispecific)
• Known central nervous system involvement of MM
• Known history of other active malignancies within the past 3 years (with specific exceptions)
• Clinically significant conditions (renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months)

Where this trial is running

• University of Arizona Cancer Center /ID# 285339, Tucson, Arizona, United States
• Toi Clinical Research - Whittier /ID# 284462, Cerritos, California, United States
• University of California Los Angeles /ID# 282444, Los Angeles, California, United States
• University Of Colorado - Anschutz Medical Campus /ID# 283478, Aurora, Colorado, United States
• MedStar Georgetown University Hospital /ID# 283734, Washington D.C., District of Columbia, United States
• Cleveland Clinic Florida /ID# 283692, Weston, Florida, United States
• Northwest Georgia Oncology Centers /ID# 284769, Marietta, Georgia, United States
• Rush University Medical Center /ID# 283095, Chicago, Illinois, United States
• Beth Israel Deaconess Medical Center /ID# 285204, Boston, Massachusetts, United States
• Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 282591, Grand Rapids, Michigan, United States
• The Mount Sinai Hospital /ID# 283535, New York, New York, United States
• Columbia University Medical Center /ID# 283510, New York, New York, United States

+ 54 more sites.

Who to contact

ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07728188.