Phase 3 Study of SCTC21C with Bortezomib, Cyclophosphamide, and Dexamethasone Compared to Bortezomib, Cyclophosphamide, and Dexamethasone Alone in Newly Diagnosed Systemic Light-Chain Amyloidosis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of SCTC21C combined with cyclophosphamide, bortezomib, and dexamethasone compared to the combination without SCTC21C in adults newly diagnosed with amyloid light-chain AL amyloidosis. This Phase 3 study aims to better understand treatment responses and survival outcomes in this condition. The study is sponsored by Sinocelltech Ltd. and involves multiple centers. The study includes two parts Part 1 focuses on safety, and Part 2 is a randomized, controlled, open-label trial. Both parts have three stages screening up to 28 days before treatment, treatment starting with Cycle 1, Day 1, continuing until disease progression or unacceptable side effects, and follow-up after treatment. Participants receive either SCTC21C plus bortezomib, cyclophosphamide, and dexamethasone or just the latter three drugs. SCTC21C and bortezomib are given by subcutaneous injection, while dexamethasone and cyclophosphamide are given orally or intravenously. Participants will attend regular visits for safety checks including physical exams, vital signs, laboratory tests, electrocardiograms, and monitoring for side effects. Researchers will measure the overall complete hematologic response, response rates, progression-free survival, and overall survival up to about 50 months after the first participant starts treatment. The study assesses adverse events and the duration of response to the therapies. The total participation time varies depending on treatment response and safety.

A Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Newly Diagnosed Systemic Light-Chain Amyloidosis (NDSLCA)