A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion Alone or in Combination With Oral, IV, Subcutaneous Daratumumab; Lenalidomide; Dexamethasone; Carfilzomib

Study Identifier
M25-059
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2024-515770-27-00
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Study Details

Medical Condition
  • Blood Cancer - Multiple Myeloma
  • Study Drug
  • Etentamig
  • Lenalidomide
  • Dexamethasone
  • Daratumumab
  • Carfilzomib
  • Phase
    Phase 1/Phase 2
    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 the safety, efficacy, and pharmacokinetics of Etentamig in adult participants with MM.

    Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 4 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants will receive escalating doses of etentamig alone or in combination with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R). This will be followed by etentamig at the dose levels established during the escalation phases alone or in combination with DR, Kd, R. The participants can also receive daratumumab, lenalidomide and dexamethasone (DRd), R, or daratumumab, carfilzomib, and dexamethasone (DKd) as a comparator in the dose expansion phases. Around 440 adult participants with MM will be enrolled at approximately 50 sites worldwide

    In all substudies, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or in combination with DR, R or Kd, followed by IV infusions of etentamig at the dose levels established during the escalation phases alone or in combination with IV and oral DRd, DKd, or R. The study duration is approximately 130 months.

    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
    Colorado Blood Cancer Institute /ID# 273129
    Denver, Colorado, United States, 80218
    Status
    Recruiting
    Location
    Moffitt Cancer Center /ID# 272628
    Tampa, Florida, United States, 33612
    Status
    Recruiting
    Location
    Winship Cancer Institute of Emory University /ID# 274830
    Atlanta, Georgia, United States, 30322
    Status
    Recruiting
    Location
    Weill Cornell Medical College /ID# 272517
    New York, New York, United States, 10065
    Status
    Recruiting
    Location
    University of North Carolina at Chapel Hill /ID# 274667
    Chapel Hill, North Carolina, United States, 27514
    Status
    Recruiting
    Location
    Atrium Health Levine Cancer Institute /ID# 276193
    Charlotte, North Carolina, United States, 28204-2990
    Status
    Recruiting
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