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A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) Given as Monotherapy or in Combination With Antimyeloma Regimens in Subjects With Multiple Myeloma
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and change in disease activity of ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change in disease activity will be assessed. ABBV-453 is an investigational drug being developed for the treatment of R/R MM. In Substudy 1 there will be a dose escalation phase where participants will receive various doses of ABBV-453 in combination with daratumumab + dexamethasone, to determine the best dose of ABBV-453. This will be followed by a dose expansion and selection phase where participants will receive 1 of 2 doses of ABBV-453 in combination with daratumumab + dexamethasone, or daratumumab + dexamethasone + pomalidomide (only during the expansion phase). In Substudy 2, there will be a dose escalation phase where participants will receive various doses of ABBV-453 alone. Approximately 130 adult participants with R/R MM will be enrolled in the study in approximately 40 sites worldwide. In Substudy 1 escalation phase, participants will receive oral ABBV-453 tablets in combination with subcutaneous (SC) daratumumab injections + oral dexamethasone tablets and in the expansion phase, will receive oral ABBV-453 tablets in combination with SC daratumumab injections + oral dexamethasone tablets or daratumumab injections + oral pomalidomide + oral dexamethasone tablets. In Substudy 2, Japanese participants will receive oral ABBV-453 tablets. The total study duration is approximately 4.5 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 an approved institution. The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Southern California /ID# 272414
Los Angeles, California, United States
University of Michigan Health System - Ann Arbor /ID# 271536
Ann Arbor, Michigan, United States
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 271214
New York, New York, United States
University of North Carolina at Chapel Hill /ID# 272454
Chapel Hill, North Carolina, United States
Northwest Medical Specialties Tacoma /ID# 272506
Tacoma, Washington, United States
Liverpool Hospital /ID# 272002
Liverpool, New South Wales, Australia
Calvary Mater Newcastle /ID# 272498
Waratah, New South Wales, Australia
St Vincent's Hospital - Melbourne /ID# 271997
Fitzroy, Victoria, Australia
Epworth Hospital /ID# 272497
Richmond, Victoria, Australia
UZ Gent /ID# 271432
Ghent, Oost-Vlaanderen, Belgium
Start Date
July 23, 2025
Primary Completion Date
December 1, 2030
Completion Date
December 1, 2030
Last Updated
February 23, 2026
130
ESTIMATED participants
ABBV-453
DRUG
Daratumumab
DRUG
Dexamethasone
DRUG
Pomalidomide
DRUG
Lead Sponsor
AbbVie
NCT06179888
NCT06152575
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 ConditionsNCT04973605