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)

Study Identifier
M25-275
CT.gov Identifier
NCT06953960
EudraCT Identifier
Not available
EUCTIS ID
2024-517140-65
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Blood Cancer - Multiple Myeloma
    • Study Drug
  • ABBV-453
  • Daratumumab
  • Dexamethasone
  • Pomalidomide
    • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and 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.

    Protocol Summary

    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 Locations

    Location
    Status
    Location
    University of Southern California /ID# 272414
    Los Angeles, California, United States, 90033
    Status
    Recruiting
    Location
    Yale University School of Medicine /ID# 272447
    New Haven, Connecticut, United States, 06510
    Status
    Recruiting
    Location
    Dana-Farber Cancer Institute /ID# 271846
    Boston, Massachusetts, United States, 02215
    Status
    Recruiting
    Location
    University of Michigan Health System - Ann Arbor /ID# 271536
    Ann Arbor, Michigan, United States, 48109
    Status
    Recruiting
    Location
    Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 271214
    New York, New York, United States, 10065
    Status
    Recruiting
    Location
    University of North Carolina at Chapel Hill /ID# 272454
    Chapel Hill, North Carolina, United States, 27514
    Status
    Recruiting
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