Phase 2b Trial of Selinexor with Low-dose Dexamethasone for Penta-refractory Multiple Myeloma and Selinexor with Bortezomib plus Low-dose Dexamethasone for Triple-class Refractory Multiple Myeloma

What this Trial Is About

This research aims to evaluate the effectiveness, cancer-fighting activity, safety, and tolerability of selinexor combined with low-dose dexamethasone in adults with penta-refractory multiple myeloma, as well as selinexor combined with bortezomib and low-dose dexamethasone in those with triple-class refractory multiple myeloma. The study is a Phase 2b, open-label, multi-arm clinical trial investigating these treatments in patients who have experienced resistance to multiple prior therapies. Participants are assigned to one of several treatment groups. One group receives a fixed dose of 40 mg selinexor tablets plus 20 mg dexamethasone tablets twice weekly on specific days during each 28-day cycle. Another group receives 100 mg selinexor and 40 mg dexamethasone once weekly, with dexamethasone dosing possibly split over two days. Some earlier treatment arms with different dosing schedules are closed to new participants. Another group receives selinexor tablets, subcutaneous bortezomib injections, and dexamethasone tablets on a 35-day cycle with flexible dexamethasone dosing. During the study, participants will be monitored for overall response rate up to about 60 months after randomization. Secondary outcomes include duration of response, clinical benefit, disease control, progression-free and overall survival, time to next treatment, and recording of adverse events. Assessments and safety monitoring occur throughout the study period to gather comprehensive data on treatment effects and tolerability.

A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM.