A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma

Study Identifier
M24-108
CT.gov Identifier
NCT05650632
EudraCT Identifier
Not available
EUCTIS ID
2023-504674-38-00
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Blood Cancer - Multiple Myeloma
    • Study Drug
  • Etentamig (ABBV-383)
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Must have measurable disease as outlined in the protocol. * Eastern Cooperative Oncology Group (ECOG) performance of \<= 2. Arm C and Arm D: ECOG performance of \<= 1. * Relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) 2016 criteria. * Must be naïve to treatment with etentamig (ABBV-383). * Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody. * Arm B: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen (BCMA)-targeted therapy (must be an anti-drug conjugate \[ADC\] or chimeric antigen receptor T-cell \[CAR-T\] directed against BCMA). * Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383). * Arm D: Must have received at least 1 and no more than 3 prior lines of therapy, including exposure to a PI, an IMiD, or an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).
    Exclusion Criteria:
    * Arm A: Received BCMA-targeted therapy. * Arm C and Arm D: Rapidly progressing disease per investigator.

    Protocol Summary

    Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). 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 adverse events and change in disease symptoms 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 Multiple Myeloma (MM). This study is broken into 4 Arms; Arm A (Parts 1 and 2), Arm B and Arms C \& D. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of etentamig (ABBV-383). In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of etentamig (ABBV-383). In Arm B a flat dose of etentamig (ABBV-383) will be tested. In Arms C \& D, the step-up dose identified in Arm A will be used followed by the target dose of etentamig (ABBV-383) to investigate outpatient administration of etentamig (ABBV-383). Around 210 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 50 sites across the world.

    Participants will receive etentamig (ABBV-383) as an infusion into the vein in 28 day cycles for approximately 3 years.

    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# 251405
    Phoenix, Arizona, United States, 85054
    Status
    Recruiting
    Location
    Highlands Oncology Group - Springdale /ID# 267742
    Springdale, Arkansas, United States, 72762
    Status
    Recruiting
    Location
    Rocky Mountain Cancer Centers - Aurora /ID# 268574
    Aurora, Colorado, United States, 80012
    Status
    Recruiting
    Location
    Medical Oncology Hematology Consultants /ID# 268560
    Newark, Delaware, United States, 19713
    Status
    Recruiting
    Location
    Hope And Healing Cancer Services /ID# 268536
    Hinsdale, Illinois, United States, 60521
    Status
    Recruiting
    Location
    Fort Wayne Medical Oncology And Hematology /ID# 268179
    Fort Wayne, Indiana, United States, 46804
    Status
    Recruiting
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