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)

Recruiting now · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT06953960

Run by

AbbVie

People needed

199

Starts

2025-07-23

Expected to finish

2030-12-01

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented diagnosis of multiple myeloma (MM) based on standard international myeloma working group (IMWG) diagnostic criteria.
• All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment:
• Serum M-protein >= 0.5 g/dL (>= 5g/L); OR
• Urine M-protein >= 200 mg/24 hours; OR
• For participants without measurable serum and urine M-protein: Serum free light chain (sFLC) ≥ 10 mg/dL (100 mg/L), provided sFLC ratio is abnormal.
• B-cell lymphoma (BCL)-2 inhibitor treatment naïve.
• t(11;14) positive status and/or BCL2 high status.
• Substudy 1 Dose Escalation Cohorts and Substudy 2:
• - Must be triple class exposed (PI, IMiD and anti-CD38) and have received 3 to 5 lines of prior antimyeloma therapy, and who have no other appropriate treatment options as deemed by the investigator.
• Substudy 1 Dose Expansion Cohorts:
• Must be double class exposed (PI, IMiD) and have received 1 to 3 lines of prior antimyeloma therapy.

You may not qualify if…

• Major surgery within 4 weeks of study treatment or planned during study participation.
• Active infections: no recent infection requiring systemic treatment that was completed <= 7 days before first dose of study treatment and/or uncontrolled systemic infection.
• Recent infection requiring systemic treatment that was completed <= 7 days before first dose of study treatment and/or uncontrolled active systemic infection.

Where it is running

• University of Southern California /ID# 272414 — Los Angeles, California, United States (enrolling)
• Yale University School of Medicine /ID# 272447 — New Haven, Connecticut, United States (enrolling)
• Dana-Farber Cancer Institute /ID# 271846 — Boston, Massachusetts, United States (enrolling)
• University of Michigan Health System - Ann Arbor /ID# 271536 — Ann Arbor, Michigan, United States (enrolling)
• Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 271214 — New York, New York, United States (enrolling)
• University of North Carolina at Chapel Hill /ID# 272454 — Chapel Hill, North Carolina, United States (enrolling)
• Atrium Health Levine Cancer Institute /ID# 271510 — Charlotte, North Carolina, United States (enrolling)
• Wake Forest Baptist Health /ID# 271294 — Winston-Salem, North Carolina, United States (enrolling)
• Oregon Health and Science University /ID# 272282 — Portland, Oregon, United States (enrolling)
• University of Texas - Southwestern Medical Center /ID# 271914 — Dallas, Texas, United States (enrolling)
• Northwest Medical Specialties Tacoma /ID# 272506 — Tacoma, Washington, United States (enrolling)
• Liverpool Hospital /ID# 272002 — Liverpool, New South Wales, Australia (enrolling)
• Calvary Mater Newcastle /ID# 272498 — Waratah, New South Wales, Australia (enrolling)
• St Vincent's Hospital - Melbourne /ID# 271997 — Fitzroy, Victoria, Australia (enrolling)
• Epworth Hospital - Richmond /ID# 272497 — Richmond, Victoria, Australia (enrolling)
• UZ Gent /ID# 271432 — Ghent, Oost-Vlaanderen, Belgium (enrolling)
• Universitair Ziekenhuis Leuven /ID# 272382 — Leuven, Vlaams-Brabant, Belgium (enrolling)
• CHU de Liege /ID# 271430 — Liège, Belgium (enrolling)
• CHU de Montpellier - Hopital Saint Eloi /ID# 275570 — Montpellier, Herault, France (enrolling)
• Centre Hospitalier Universitaire de Poitiers /ID# 275563 — Poitiers, New Aquitaine, France (enrolling)
• IUCT Oncopole /ID# 275568 — Toulouse, Occitanie, France (enrolling)
• Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 275562 — Nantes, Pays de la Loire Region, France (enrolling)
• Hopital Universitaire Necker Enfants Malades /ID# 275571 — Paris, Île-de-France Region, France (enrolling)
• Universitaetsklinikum Heidelberg /ID# 275598 — Heidelberg, Baden-Wurttemberg, Germany (enrolling)
• Klinikum der Universitaet Muenchen Grosshadern /ID# 276658 — Munich, Bavaria, Germany (enrolling)

Full record on ClinicalTrials.gov

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