A Study to Assess Adverse Events and Change in Disease Activity of Oral Surzetoclax Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM) (NCT06953960)
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
🩺 Plain-English Summary (8th-Grade Level)
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 surzetoclax in adult participants with relapsed/refractory (R/R) MM. Adverse events and change in disease activity will be assessed. Surzetoclax 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 surzetoclax in combination with daratumumab + dexamethasone, to determine the best dose of surzetoclax. This will be followed by a dose expansion and selection phase where participants will receive 1 of 2 doses of surzetoclax 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 surzetoclax 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 surzetoclax tablets in combination with subcutaneous (SC) daratumumab injections + oral dexamethasone tablets and in the expansion phase, will receive oral surzetoclax 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 surzetoclax 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.
Who can join: Review the eligibility criteria below.
Location: University of Southern California /ID# 272414 — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (48 Sites)
Showing the first 25 of 48 sites.
- University of Southern California /ID# 272414 — Los Angeles, California
- Yale University School of Medicine /ID# 272447 — New Haven, Connecticut
- Dana-Farber Cancer Institute /ID# 271846 — Boston, Massachusetts
- University of Michigan Health System - Ann Arbor /ID# 271536 — Ann Arbor, Michigan
- Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 271214 — New York, New York
- University of North Carolina at Chapel Hill /ID# 272454 — Chapel Hill, North Carolina
- Atrium Health Levine Cancer Institute /ID# 271510 — Charlotte, North Carolina
- Wake Forest Baptist Health /ID# 271294 — Winston-Salem, North Carolina
- Oregon Health and Science University /ID# 272282 — Portland, Oregon
- University of Texas - Southwestern Medical Center /ID# 271914 — Dallas, Texas
- Northwest Medical Specialties Tacoma /ID# 272506 — Tacoma, Washington
- Liverpool Hospital /ID# 272002 — Liverpool, New South Wales
- Calvary Mater Newcastle /ID# 272498 — Waratah, New South Wales
- St Vincent's Hospital - Melbourne /ID# 271997 — Fitzroy, Victoria
- Epworth Hospital - Richmond /ID# 272497 — Richmond, Victoria
- UZ Gent /ID# 271432 — Ghent, Oost-Vlaanderen
- Universitair Ziekenhuis Leuven /ID# 272382 — Leuven, Vlaams-Brabant
- CHU de Liege /ID# 271430 — Liège,
- CHU de Montpellier - Hopital Saint Eloi /ID# 275570 — Montpellier, Herault
- Centre Hospitalier Universitaire de Poitiers /ID# 275563 — Poitiers, New Aquitaine
- IUCT Oncopole /ID# 275568 — Toulouse, Occitanie
- Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 275562 — Nantes, Pays de la Loire Region
- Hopital Universitaire Necker Enfants Malades /ID# 275571 — Paris, Île-de-France Region
- Universitaetsklinikum Heidelberg /ID# 275598 — Heidelberg, Baden-Wurttemberg
- Klinikum der Universitaet Muenchen Grosshadern /ID# 276658 — Munich, Bavaria
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.