Phase 1 Study of SX-682 with Carfilzomib, Daratumumab-Hyaluronidase, and Dexamethasone for Adults with Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating the safety and side effects of an investigational drug called SX-682 when combined with standard treatments carfilzomib, daratumumab-hyaluronidase, and dexamethasone in patients with relapsed or refractory multiple myeloma. This is a phase 1 trial focused on patients whose disease has returned or not responded to previous therapies. SX-682 is designed to help the immune system better attack tumor cells by blocking specific sites that suppress immune activity, while the other drugs work by stopping tumor growth and supporting immune response. Participants receive SX-682 by mouth twice daily on days 1 through 21 of each 28-day cycle. They also receive daratumumab-hyaluronidase as a subcutaneous injection weekly for the first two cycles, then every two weeks for cycles three through six. Carfilzomib is given intravenously on days 1, 8, and 15, and dexamethasone is taken orally on days 1, 8, 15, and 22 of each cycle. Treatment cycles may continue up to six cycles if tolerated without disease progression, and patients with sustained response may continue these medications on the same schedule. During the study, participants undergo blood sample collection, bone marrow aspiration, echocardiograms, and imaging scans such as PETCT or MRI to monitor their condition. Researchers measure side effects including dose-limiting toxicity in the first 28 days, as well as overall response, progression-free survival, overall survival, and adverse events over time. The trial aims to assess the safety of this drug combination and its effects on the disease over a follow-up period extending up to three years after the last patient enrollment.

SX-682 in Combination With Carfilzomib, Daratumumab-Hyaluronidase, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma