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Oral ABBV-453 alone or with daratumumab and other myeloma medicines for adults with multiple myeloma

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

Phase1; Phase2 Interventional AbbVie · NCT06953960

This trial tests whether oral ABBV-453, given alone or with daratumumab plus dexamethasone and sometimes pomalidomide, is safe and can lower disease activity in adults with relapsed or refractory multiple myeloma.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment130 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsdaratumumab
Locations32 sites (Los Angeles, California and 31 other locations)
Trial IDNCT06953960 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 interventional study includes two substudies: one combining ABBV-453 with daratumumab and dexamethasone (with pomalidomide allowed in expansion) and one testing ABBV-453 alone. It begins with dose-escalation cohorts to identify tolerable dose levels and then proceeds to dose-expansion cohorts to further characterize safety and effects on disease activity. The trial enrolls adults with measurable relapsed/refractory multiple myeloma, enriched for t(11;14)-positive or BCL2-high disease. Adverse events and changes in standard myeloma activity measures are collected to inform future development.

Who should consider this trial

Good fit: Adults with relapsed or refractory multiple myeloma who are t(11;14)-positive or BCL2-high, have measurable disease, and have received prior therapies (typically 3–5 lines and triple-class exposure for certain cohorts) are the intended candidates.

Not a fit: Patients without t(11;14) or BCL2-high disease, those without measurable disease, or those who are treatment-naïve or lack adequate organ function may be unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, ABBV-453 could provide a new targeted oral option that improves disease control for patients with t(11;14) or BCL2-high multiple myeloma.

How similar studies have performed: BCL-2–targeting approaches (for example, venetoclax in t(11;14) myeloma) and daratumumab combinations have shown promise in prior studies, but ABBV-453 itself is investigational with limited prior data.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 this trial is running

Los Angeles, California and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple MyelomaABBV-453DaratumumabDexamethasonePomalidomideCancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.