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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 20 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05286229
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AbbVie
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

ABBVIE INC.
Principal Investigator Affiliation AbbVie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Relapsed/Refractory Multiple Myeloma
Arms & Interventions

Arms

Experimental: Cohort 1 (ABBV-383 Dose A)

Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive ABBV-383 dose A in 21-day cycles.

Experimental: Cohort 2 (ABBV-383 Dose B)

Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 dose B in 21-day cycles.

Interventions

Drug: - ABBV-383

Intravenous (IV) Infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Kashiwa-shi, Chiba, Japan

Status

Recruiting

Address

National Cancer Center Hospital East /ID# 240943

Kashiwa-shi, Chiba, 277-8577

Hokkaido University Hospital /ID# 242672, Sapporo-shi, Hokkaido, Japan

Status

Recruiting

Address

Hokkaido University Hospital /ID# 242672

Sapporo-shi, Hokkaido, 060-8648

Kanazawa University Hospital /ID# 240948, Kanazawa-shi, Ishikawa, Japan

Status

Recruiting

Address

Kanazawa University Hospital /ID# 240948

Kanazawa-shi, Ishikawa, 920-8641

Okayama Medical Center /ID# 240949, Okayama-shi, Okayama, Japan

Status

Completed

Address

Okayama Medical Center /ID# 240949

Okayama-shi, Okayama, 701-1192

Osaka University Hospital /ID# 242032, Suita-shi, Osaka, Japan

Status

Recruiting

Address

Osaka University Hospital /ID# 242032

Suita-shi, Osaka, 565-0871

Yamagata University Hospital /ID# 240945, Yamagata-shi, Yamagata, Japan

Status

Recruiting

Address

Yamagata University Hospital /ID# 240945

Yamagata-shi, Yamagata, 990-9585