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

  • STATUS
    Recruiting
  • End date
    Jan 4, 2025
  • participants needed
    12
  • sponsor
    AbbVie
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Updated on 4 October 2022
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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 ABBV-383 in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state will be assessed.

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) 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.

Details
Condition Relapsed/Refractory Multiple Myeloma
Treatment ABBV-383
Clinical Study IdentifierNCT05286229
SponsorAbbVie
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance of <= 2
Must have adequate bone marrow function as defined in the protocol
Must meet laboratory parameters as outlined in the protocol
Must have a confirmed diagnosis of 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) criteria
Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy, but does not meet criteria for refractory myeloma
Refractory defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy, or progresses within 60 days of last therapy
Must have received at least 3 prior lines of therapy (including exposure to a
proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38
mAb)
Must have measurable disease within 28 days of enrollment, defined as at least 1 of the following
Serum M-protein >= 0.5 g/dL (>= 5 g/L)
Urine M-protein >= 200 mg/24 hours
Serum free light chain (FLC) >= 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio only for participants without measurable serum or urine M-protein
Consents to a fresh pretreatment bone marrow tumor biopsy or has adequate archival
bone marrow tumor tissue that was collected within 12 weeks prior to screening
and without intervening treatment

Exclusion Criteria

Has received B-cell maturation antigen (BCMA)-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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