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 b

Trial Details

NCT ID
NCT06953960
Phase
PHASE1 / PHASE2
Sponsor
AbbVie
Status
RECRUITING
Cancer Type
Relapsed/Refractory Multiple Myeloma
Interventions
  • ABBV-453
  • Daratumumab
  • Dexamethasone
  • Pomalidomide
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Ann Arbor, Michigan, United States|42.27756,-83.74088
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility 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 full eligibility, visit ClinicalTrials.gov.

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