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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
Sponsor: Sinocelltech Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
292
Start Date
2025-12-29
Completion Date
2028-12
Last Updated
2026-01-29
Healthy Volunteers
No
Conditions
Interventions
SCTC21C
Pharmaceutical form: Solution for infusion; Route of administration: Subcutaneous
Bortezomib
Pharmaceutical form: Lyophilized powder for injection; Route of administration: Subcutaneous
Lenalidomide
Pharmaceutical form: Capsules; Route of administration: Oral
Dexamethasone
Pharmaceutical form: Tablets, ampoules or vials for injection; Route of administration: Oral/Intravenous
Locations (1)
Beijing Chaoyang Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China