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A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Etentamig (ABBV-383) Monotherapy in Japanese Subjects With Relapsed or Refractory Multiple Myeloma (4L+ RRMM Monotherapy Study)
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.
Age
20 - No limit years
Sex
ALL
Healthy Volunteers
No
National Cancer Center Hospital East /ID# 240943
Kashiwa-shi, Chiba, Japan
Hokkaido University Hospital /ID# 242672
Sapporo, Hokkaido, Japan
Kanazawa University Hospital /ID# 240948
Kanazawa, Ishikawa-ken, Japan
Duplicate_Okayama Medical Center /ID# 240949
Okayama, Okayama-ken, Japan
The University of Osaka Hospital /ID# 242032
Suita-shi, Osaka, Japan
Yamagata University Hospital /ID# 240945
Yamagata, Yamagata, Japan
Start Date
March 24, 2022
Primary Completion Date
March 1, 2026
Completion Date
March 1, 2026
Last Updated
August 8, 2025
8
ACTUAL participants
Etentamig
DRUG
Lead Sponsor
AbbVie
NCT04973605
NCT05862012
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07284758