Study of ABBV-383 Assessing Adverse Events and Clinical Activity With Subcutaneous (SC) Injection in Adult Participants With Relapsed or Refractory Multiple Myeloma

Study Identifier
M23-001
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2023-507901-32-00
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Study Details

Medical Condition
  • Blood Cancer - Multiple Myeloma
  • Study Drug
  • Subcutaneous (SC) Etentamig
  • Intravenous (IV) Etentamig
  • Phase
    Phase 1
    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 and pharmacokinetics of Etentamig (ABBV-383) in adult participants with relapsed/refractory (R/R) MM.

    Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R MM. This study is broken into 3 Arms: Arm A with 2 parts and Arm B as an expansion. Participants will receive ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusion in Arm A and SC injections of ABBV-383 in Arm B. Around 55 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 15 sites across the world

    In Arm A participants will receive one of two doses of Etentamig (ABBV-383) as an SC injection and (IV) infusions, during the 151 week study duration. In Arm B, participants will receive the selected dose from Arm A as SC injections, during the 151 week 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
    Mayo Clinic Arizona /ID# 260799
    Phoenix, Arizona, United States, 85054
    Status
    Not applicable
    Location
    Mayo Clinic Hospital Jacksonville /ID# 262808
    Jacksonville, Florida, United States, 32224
    Status
    Not applicable
    Location
    Sylvester Comprehensive Cancer Center /ID# 260798
    Miami, Florida, United States, 33136-1002
    Status
    Not applicable
    Location
    University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 261050
    Ann Arbor, Michigan, United States, 48109
    Status
    Not applicable
    Location
    Mayo Clinic - Rochester /ID# 262807
    Rochester, Minnesota, United States, 55905-0001
    Status
    Not applicable
    Location
    Atrium Health Wake Forest Baptist Medical Center /ID# 260807
    Winston-Salem, North Carolina, United States, 27157
    Status
    Not applicable
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