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)

Part of paid clinical trials in Los Angeles, California.

Sponsor
AbbVie
Study ID
NCT06953960
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ABBV-453 — DRUG
    Oral Tablet
  • Daratumumab — DRUG
    Subcutaneous (SC) Injection
  • Dexamethasone — DRUG
    Oral Tablet
  • Pomalidomide — DRUG
    Oral Capsule

Study Details

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 Dates

Start date
Jul 23, 2025
Status verified
May 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
199 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Substudy 1: Dose Escalation ABBV-453 Combination
    Participants will receive various doses of ABBV-453 in combination with daratumumab + dexamethasone, to determine the best dose of ABBV-453, as part of the total 4.5 year study duration.
  • Experimental: Substudy 1: Dose Expansion and Selection ABBV-453 Combination
    Participants will receive 1 of 2 doses of ABBV-453 in combination with daratumumab + dexamethasone, as part of the total 4.5 year study duration.
  • Active Comparator: Substudy 1: Dose Expansion and Selection Control
    Participants will receive daratumumab, dexamethasone, and pomalidomide, as part of the total 4.5 year study duration.
  • Experimental: Substudy 2: Dose Escalation ABBV-453 Monotherapy
    Japanese participants will receive various doses of ABBV-453 as a monotherapy, to determine the best dose of ABBV-453, as part of the total 4.5 year study duration.

Primary Outcome Measure

Dose-Limiting Toxicities (DLT)s of ABBV-453 [ Time Frame: Up to Approximately 45 Months ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
University of Southern California /ID# 272414Los AngelesCalifornia90033-
Yale University School of Medicine /ID# 272447New HavenConnecticut06510-
Dana-Farber Cancer Institute /ID# 271846BostonMassachusetts02215-
University of Michigan Health System - Ann Arbor /ID# 271536Ann ArborMichigan48109-
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 271214New YorkNew York10065-
University of North Carolina at Chapel Hill /ID# 272454Chapel HillNorth Carolina27514-
Atrium Health Levine Cancer Institute /ID# 271510CharlotteNorth Carolina28204-
Wake Forest Baptist Health /ID# 271294Winston-SalemNorth Carolina27103-
University of Texas - Southwestern Medical Center /ID# 271914DallasTexas75235-
Northwest Medical Specialties Tacoma /ID# 272506TacomaWashington98405-

Find similar trials in Los Angeles, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Southern California· Los Angeles, CAYale University School of Medicine· New Haven, CTDana-Farber Cancer Institute· Boston, MAUniversity of Michigan Health System - Ann Arbor· Ann Arbor, MIMemorial Sloan Kettering Cancer Center - New York - York Avenue· New York, NYUniversity of North Carolina at Chapel Hill· Chapel Hill, NC

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