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)

ClinicalTrials.gov ID: NCT06953960

Public ClinicalTrials.gov record NCT06953960. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06953960
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: AbbVie; Industry
Enrollment: 199 participants

Conditions and interventions

Conditions

Multiple Myeloma

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 22, 2025
Primary completion: Nov 30, 2030
Completion: Nov 30, 2030
Last update posted: Jul 6, 2026

2025 – 2030

United States locations

U.S. sites: 11
U.S. states: 9
U.S. cities: 11

Facility	City	State	ZIP	Site status
University of Southern California /ID# 272414	Los Angeles	California	90033	Recruiting
Yale University School of Medicine /ID# 272447	New Haven	Connecticut	06510	Recruiting
Dana-Farber Cancer Institute /ID# 271846	Boston	Massachusetts	02215	Recruiting
University of Michigan Health System - Ann Arbor /ID# 271536	Ann Arbor	Michigan	48109	Recruiting
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 271214	New York	New York	10065	Recruiting
University of North Carolina at Chapel Hill /ID# 272454	Chapel Hill	North Carolina	27514	Recruiting
Atrium Health Levine Cancer Institute /ID# 271510	Charlotte	North Carolina	28204	Recruiting
Wake Forest Baptist Health /ID# 271294	Winston-Salem	North Carolina	27103	Recruiting
Oregon Health and Science University /ID# 272282	Portland	Oregon	97239	Recruiting
University of Texas - Southwestern Medical Center /ID# 271914	Dallas	Texas	75235	Recruiting
Northwest Medical Specialties Tacoma /ID# 272506	Tacoma	Washington	98405	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 37 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06953960, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 6, 2026 · Synced Sep 1, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06953960 live on ClinicalTrials.gov.

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