A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Lenalidomide and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate if the addition of SCTC21C to bortezomib, lenalidomide and dexamethasone (VRd) in patients with newly diagnosed multiple myeloma not eligible for transplant will prolong progression-free survival (PFS) and/or improve overall minimal residual disease (MRD) negativity rate compared with VRd alone.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Newly diagnosed multiple myeloma (IMWG criteria) not eligible for transplant.
• Evidence of measurable disease.
• With adequate organ function and hematological parameters.
• Contraception，and during the study period and for 5 months after the last dose, all subjects must not donate reproductive cells.
Locations
Other Locations
China
Beijing Chaoyang Hospital affiliated to Capital Medical University
RECRUITING
Beijing
Time Frame
Start Date: 2025-12-29
Estimated Completion Date: 2028-12
Participants
Target number of participants: 292
Treatments
Experimental: SCTC21C + VRd (S-VRd)
Active_comparator: VRd
Related Therapeutic Areas
Sponsors
Leads: Sinocelltech Ltd.