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)

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Surzetoclax — DRUG
  Oral
• Daratumumab — DRUG
  Subcutaneous (SC) Injection
• Dexamethasone — DRUG
  Oral
• Pomalidomide — DRUG
  Oral
• Etentamig — DRUG
  Intravenous Infusion

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 dose escalation and dose expansion phases where participants will receive various doses (escalation) or 1 of 2 doses (expansion) of surzetoclax in combination with daratumumab + dexamethasone, to determine the best dose of surzetoclax. In Substudy 2, there will be a dose escalation phase where participants will receive various doses of surzetoclax alone. In Substudy 3 there will be dose escalation and optimization phases where participants will receive various doses (escalation) or 1 of 2 doses (optimization) of of surzetoclax and etentamig to determine the best dose of surzetoclax and etentamig. Optimization will also include etentamig received alone. Approximately 325 adult participants with R/R MM will be enrolled in the study in approximately 55 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 1 of 2 doses 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. In Substudy 3 escalation phase, participants will receive oral surzetoclax tablets in combination with IV etentamig and in the expansion phase, will receive 1 of 2 doses of both oral surzetoclax tablets in combination with of IV etentamig, or IV etentamig alone. 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

First listed

May 1, 2025

Start date

Jul 23, 2025

Status verified

Sep 2026

Primary completion

Dec 31, 2030

Completion

Dec 31, 2030

Study Design

Enrollment

325 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Substudy 1: Dose Escalation Surzetoclax Combination
  Participants will receive various doses of surzetoclax in combination with daratumumab + dexamethasone, to determine the best dose of surzetoclax, as part of the total 4.5 year study duration.
• Experimental: Substudy 1: Dose Optimization & 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 Optimization & 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.
• Experimental: Substudy 3: Dose Escalation Surzetoclax + Etentamig
  Participants will receive various doses of both surzetoclax and etentamig, to determine the best dose of surzetoclax and etentamig, as part of the total 4.5 year study duration.
• Experimental: Substudy 3: Dose Optimization Etentamig Dose A Combination
  Participants will receive etentamig dose A in combination with surzetoclax, as part of the total 4.5 year study duration.
• Experimental: Substudy 3: Dose Optimization Etentamig Dose B Combination
  Participants will receive etentamig dose B in combination with surzetoclax, as part of the total 4.5 year study duration.
• Experimental: Substudy 3: Dose Optimization Etentamig Monotherapy
  Participants will receive etentamig, 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

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (12)

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