Phase 3 Study of SCTC21C Added to Bortezomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma Patients Not Eligible for Transplant

What this Trial Is About

Researchers are evaluating the addition of SCTC21C to a combination of bortezomib, lenalidomide, and dexamethasone VRd in patients with newly diagnosed multiple myeloma who are not eligible for transplant. The study aims to determine if this combination can extend progression-free survival and improve the rate of minimal residual disease negativity compared with VRd alone. This is a phase 3, randomized, open-label, multicenter trial sponsored by Sinocelltech Ltd. The study includes two phases Part 1 focuses on safety assessment, and Part 2 is a randomized controlled study. Both phases consist of a screening period up to 28 days before treatment, a treatment period starting with Cycle 1 28 days per cycle and continuing until disease progression or unacceptable side effects, and a follow-up period after treatment ends. Treatments include SCTC21C administered subcutaneously alongside bortezomib subcutaneous, lenalidomide capsules oral, and dexamethasone oral or intravenous. Participants will undergo regular evaluations including physical exams, vital signs, laboratory tests, electrocardiograms, and monitoring for adverse events. Researchers will measure progression-free survival, minimal residual disease negativity, overall response rate, and duration of response. Safety will be closely monitored throughout the study and for up to about 84 months after the first participant begins treatment, including tracking treatment-related adverse events and serious adverse events.

A Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant