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Study of Surzetoclax for Multiple Myeloma

This study is for adults with multiple myeloma (MM), a type of blood cancer, that has come back or is not responding to treatment (relapsed/refractory). It's looking at the safety and how well an investigational drug called surzetoclax works, either by itself or with other anti-myeloma medicines like daratumumab, dexamethasone, or pomalidomide. Researchers will be watching for any side effects (adverse events) and changes in your disease activity. To join, you must have a confirmed diagnosis of MM and measurable disease. The study aims to find the best dose of surzetoclax when combined with other treatments.

Study design
This is an interventional study planning to enroll 199 participants. It will include a dose escalation phase to find the best dose of surzetoclax.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor for dose-limiting toxicities for up to approximately 45 months and adverse events for up to approximately 4.5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06953960

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
PHASE1Ages 18+InterventionalTreatment
AbbVie
~199 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:ABBV-453DaratumumabDexamethasonePomalidomide

At a glance

Recruiting sites
48 of 48 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-Limiting Toxicities (DLT)s of ABBV-453
Measured over Up to Approximately 45 Months
+1 more outcome measured

Conditions

Multiple Myeloma

Explore related trials

Multiple MyelomaBCL2 Genet(11;14)

Where it's being run

48 sites across 38 states
North Carolina3
New South Wales2
Victoria2
Bavaria2
Tel Aviv2
Israel2
Lublin Voivodeship2
Portugal2

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
Substudy 1 Dose Expansion Cohorts:
Must be double class exposed (PI, IMiD) and have received 1 to 3 lines of prior antimyeloma therapy.

Exclusion

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.

What this trial measures

  • Dose-Limiting Toxicities (DLT)s of ABBV-453Up to Approximately 45 Months

    DLT events are defined as specific clinically significant adverse events or abnormal laboratory values assessed as events regardless of attribution to ABBV-453, except those clearly and incontrovertibly associated with underlying disease or extraneous causes.

  • Number of Participants with Adverse Events (AE)sUp to Approximately 4.5 Years

    An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.