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A Study to Assess Adverse Events and Change in Disease Activity of Oral ABBV-453 Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM)
Sponsor: AbbVie
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2025-07-23
Completion Date
2030-12
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
ABBV-453
Oral Tablet
Daratumumab
Subcutaneous (SC) Injection
Dexamethasone
Oral Tablet
Pomalidomide
Oral Capsule
Locations (32)
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
Universitair Ziekenhuis Leuven /ID# 272382
Leuven, Vlaams-Brabant, Belgium
CHU de Liege /ID# 271430
Liège, Belgium
CHU de Montpellier - Hopital Saint Eloi /ID# 275570
Montpellier, Herault, France
Centre Hospitalier Universitaire de Poitiers /ID# 275563
Poitiers, Nouvelle-Aquitaine, France
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 275562
Nantes, Pays de la Loire Region, France
Hopital Universitaire Necker Enfants Malades /ID# 275571
Paris, Île-de-France Region, France
The Chaim Sheba Medical Center /ID# 271251
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 271252
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus- Haifa /ID# 271256
Haifa, Israel
Hadassah Medical Center-Hebrew University /ID# 271253
Jerusalem, Israel
Rabin Medical Center. /ID# 272073
Petah Tikva, Israel
Nagoya City University Hospital /ID# 271427
Nagoya, Aichi-ken, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 271911
Kyoto, Kyoto, Japan
The University of Osaka Hospital /ID# 271636
Suita-shi, Osaka, Japan
Japanese Red Cross Medical Center /ID# 272018
Shibuya-ku, Tokyo, Japan
The Jikei University Hospital /ID# 272091
Tokyo, Japan
Instituto Portugues de Oncologia de Lisboa Francisco Gentil /ID# 275873
Lisbon, Lisbon District, Portugal
Unidade Local de Saude de Braga, EPE /ID# 275853
Braga, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 275851
Porto, Portugal
Karolinska University Hospital Solna /ID# 271674
Solna, Stockholm County, Sweden
Sodra Alvsborgs sjukhus /ID# 271822
Borås, Västra Götaland County, Sweden
Sahlgrenska Universitetssjukhuset /ID# 272448
Gothenburg, Västra Götaland County, Sweden