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

Study Identifier
M22-984
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Blood Cancer - Multiple Myeloma
  • Study Drug
  • Etentamig
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    20+ years

    Protocol Summary

    Multiple myeloma (MM) is an incurable disease characterized by the growth of monoclonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease state of etentamig in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state will be assessed.

    Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Two doses of ABBV-383 will be explored. Each treatment arm receives a different dose of ABBV-383 to determine a tolerable dose. Approximately 12 adult participants with R/R MM will be enrolled in the study in approximately 6 sites in Japan.

    Participants will receive intravenous (IV) Etentamig (ABBV-383) at two increasing doses in 21-day cycles.

    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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and and monitoring of side effects.

    Study Locations

    Location
    Status
    Location
    National Cancer Center Hospital East /ID# 240943
    Kashiwa-shi, Chiba, Japan, 277-8577
    Status
    Not applicable
    Location
    Hokkaido University Hospital /ID# 242672
    Sapporo, Hokkaido, Japan, 060-8648
    Status
    Not applicable
    Location
    Kanazawa University Hospital /ID# 240948
    Kanazawa, Ishikawa-ken, Japan, 920-8641
    Status
    Not applicable
    Location
    Duplicate_Okayama Medical Center /ID# 240949
    Okayama, Okayama-ken, Japan, 701-1192
    Status
    Not applicable
    Location
    The University of Osaka Hospital /ID# 242032
    Suita-shi, Osaka, Japan, 565-0871
    Status
    Not applicable
    Location
    Yamagata University Hospital /ID# 240945
    Yamagata, Yamagata, Japan, 990-9585
    Status
    Not applicable