Phase 3 Trial Comparing SG301 Plus Pomalidomide and Dexamethasone Versus Placebo for Adults With Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are studying relapsed or refractory multiple myeloma in adults who have already received treatment with lenalidomide and a proteasome inhibitor but whose disease has progressed. The study aims to evaluate the effects of adding SG301 injection to the standard treatment of pomalidomide and dexamethasone. This is a randomized, placebo-controlled, double-blind, multicenter phase III clinical trial. The study has two stages. Stage 1 is to find the right dose of SG301 combined with pomalidomide and dexamethasone. Stage 2 randomly assigns participants to receive either SG301 injection plus pomalidomide and dexamethasone or a placebo plus the same drugs. SG301 and its placebo are given by intravenous infusion weekly for 8 weeks, then every 2 weeks. Pomalidomide capsules are taken orally once daily on days 1 to 21 of each 28-day cycle. Dexamethasone is taken orally or by infusion on days 1, 8, 15, and 22, with dose adjusted for low body weight. Participants continue treatment until their disease progresses, unacceptable side effects occur, or other stopping criteria are met. Researchers will monitor side effects, drug levels in the body, immune response, and treatment effects including progression-free survival and overall survival for up to about 4 years. The study includes regular assessments every 4 weeks initially, then every 8 weeks, with safety followed for about 30 days after treatment ends.

A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients