Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma

Study Identifier
M22-574
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2023-506668-15-00
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Study Details

Medical Condition
  • Blood Cancer - Multiple Myeloma
  • Study Drug
  • Etentamig
  • Carfilzomib
  • Pomalidomide
  • Elotuzumab
  • Selinexor
  • Bortezomib
  • Dexamethasone
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    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. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM.

    Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world.

    In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

    Study Locations

    Location
    Status
    Location
    University of Alabama at Birmingham - Main /ID# 261434
    Birmingham, Alabama, United States, 35233
    Status
    Recruiting
    Location
    Mayo Clinic Hospital - Phoenix /ID# 263326
    Phoenix, Arizona, United States, 85054
    Status
    Recruiting
    Location
    Alta Bates Summit Medical Center for Research /ID# 261438
    Berkeley, California, United States, 94705
    Status
    Completed
    Location
    Providence - St. Jude Medical Center /ID# 262031
    Fullerton, California, United States, 92835
    Status
    Recruiting
    Location
    VA Loma Linda Healthcare System /ID# 261015
    Loma Linda, California, United States, 92357
    Status
    Recruiting
    Location
    Cedars-Sinai Medical Center /ID# 261008
    Los Angeles, California, United States, 90048
    Status
    Recruiting
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