Phase 2 Study of Venetoclax Combined With Isatuximab and Dexamethasone for Patients With Relapsed or Refractory Multiple Myeloma and t1114 Marker

What this Trial Is About

This research aims to evaluate the safety and effectiveness of combining venetoclax, isatuximab, and dexamethasone for patients with relapsed or refractory multiple myeloma MM who have the t1114 chromosomal marker. MM is a cancer of B-cells that often becomes resistant to treatment, requiring new therapies. Venetoclax targets the BCL-2 protein, which is highly expressed in patients with t1114, while isatuximab is an antibody therapy targeting CD38, both of which have shown promise in prior studies. Participants receive venetoclax orally at 400 mg daily for 28 days per cycle, dexamethasone 40 mg intravenously once a week with some doses possibly given by mouth, and isatuximab intravenously on days 1, 8, 15, and 22 during the first cycle, then on days 1 and 15 in subsequent 28-day cycles. This open-label phase 2 trial focuses on patients who have had at least three prior therapies and currently show disease progression. The study aims to determine safety by tracking side effects and dose-limiting toxicities. During the study, participants will be monitored for treatment-emergent adverse events and response rates over up to 54 months. Researchers will assess measures such as overall response rate, clinical benefit rate, progression-free survival, time to progression, and overall survival. Regular laboratory tests, imaging, and clinical evaluations will be conducted to follow disease status and safety throughout treatment and follow-up periods.

A Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma