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.
Inclusion Criteria:
Exclusion Criteria:
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Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
Participants will receive Investigator's choice of SATs: DPd, DKd, or teclistamab monotherapy as part of the 75 month study duration.
Washington D.C., District of Columbia 20007, United States
Grand Rapids, Michigan 49503, United States
Chapel Hill, North Carolina 27599, United States
Victoria, British Columbia V8R 6V5, Canada
London, Ontario N6A 5W9, Canada
Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54511, France
Nantes, Pays de la Loire Region 44000, France
Meldola, Forlì-Cesena 47014, Italy
Lisbon, Lisbon District 1449-005, Portugal
Vila Nova de Gaia, Porto District 4434-502, Portugal
Edinburgh, Edinburgh, City of EH4 2XU, United Kingdom
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