Study of Sonrotoclax With Dexamethasone Plus Carfilzomib, Daratumumab, or Pomalidomide for Adults with Relapsed or Refractory Multiple Myeloma and t1114 Chromosomal Translocation

What this Trial Is About

Researchers are studying sonrotoclax alone and in combination with dexamethasone plus carfilzomib, daratumumab, or pomalidomide to evaluate its safety, tolerability, and effectiveness in adults with relapsed or refractory multiple myeloma who have the chromosomal translocation t1114. This phase 1b2 trial aims to find the best doses and assess how well these treatments work, focusing on patients whose disease has progressed after previous therapies. Participants receive sonrotoclax as an oral daily medication, with dexamethasone given once weekly either orally or intravenously. Additional drugs include carfilzomib administered intravenously weekly, daratumumab given subcutaneously weekly, and pomalidomide taken orally daily. The study includes a dose-escalation phase to identify the maximum tolerated dose and up to seven expansion groups to further evaluate safety and response in different treatment combinations. During the study, participants are closely monitored for side effects and treatment responses through regular assessments including blood tests and bone marrow analysis. Key outcomes measured include dose-limiting toxicities, adverse events, and various levels of treatment response over approximately four years. This comprehensive follow-up helps researchers understand how the treatments affect disease progression and overall survival.

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma