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NCT Number: 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)

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Liverpool Hospital /ID# 272002, Liverpool, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-453

Drug

Oral Tablet

Daratumumab

Drug

Subcutaneous (SC) Injection

Dexamethasone

Drug

Oral Tablet

Pomalidomide

Drug

Oral Capsule

Primary outcomes

  1. Dose-Limiting Toxicities (DLT)s of ABBV-453

    Time frame: Up 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.

  2. Number of Participants with Adverse Events (AE)s

    Time frame: Up 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.

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Up to Approximately 4.5 Years

    ORR is defined as the percentage of participants with a confirmed partial response (PR), very good partial response, complete response (CR) or stringent complete response (sCR) per Investigator review according to International Myeloma Working Group (IMWG) 2016 criteria.

  2. Progression-Free Survival (PFS)

    Time frame: Up to Approximately 4.5 Years

    PFS is defined as time from first study treatment to the earliest documented disease progression according to IMWG 2016 criteria, as determined by the investigator, or death due to any cause, whichever occurs earlier.

  3. Duration of Response (DOR)

    Time frame: Up to Approximately 4.5 Years

    DOR is defined as the time from the date of achieving the first confirmed sCR/CR/VGPR/PR to the date of recurrence disease progression according to IMWG 2016 criteria, as determined by the investigator, or death of any cause, whichever occurs earlier.

  4. Time-to-Progression (TTP)

    Time frame: Up to Approximately 4.5 Years

    TTP will be defined as the number of days from the date of first dose to the date of earliest disease progression.

  5. Time to Next Treatment

    Time frame: Up to Approximately 4.5 Years

    Time to next treatment will be defined as the number of days from the date of first dose to the date of next treatment.

  6. Minimal Residual Disease (MRD) Negativity

    Time frame: Up to Approximately 4.5 Years

    MRD negativity is defined as having less than 1 myeloma cell that may remain in the bone marrow aspirate per 10^5 nucleated cells and rate of MRD negativity will be determined.

  7. Overall Survival (OS)

    Time frame: Up to Approximately 4.5 Years

    OS is defined as time from first study treatment to death due to any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
May 1, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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