Phase 12 Study of Oral Surzetoclax Alone or with Daratumumab, Dexamethasone, and Pomalidomide for Adults with Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating surzetoclax, an investigational drug, alone or combined with other anti-myeloma agents, in adults with relapsed or refractory multiple myeloma MM. The study aims to assess safety and changes in disease activity, including adverse events and response to treatment. This phase 12 trial includes participants who have previously received multiple therapies and have limited treatment options. The study has two substudies. Substudy 1 has a dose escalation phase testing surzetoclax combined with daratumumab and dexamethasone, followed by a dose expansion phase where participants receive surzetoclax with daratumumab and dexamethasone or with daratumumab, pomalidomide, and dexamethasone. Substudy 2 involves Japanese participants receiving various doses of surzetoclax alone. The total duration of participation may last about 4.5 years. Participants will attend regular visits for medical assessments, blood tests, and monitoring of side effects throughout the study. Researchers will measure dose-limiting toxicities and adverse events up to approximately 4.5 years, along with response rates, progression-free survival, duration of response, and overall survival. The study includes frequent safety and disease activity checks to evaluate the treatments impact over time.

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)