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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)
Sponsor: Sinocelltech Ltd.
Summary
The purpose of this study is to evaluate the efficacy and safety of SCTC21C plus cyclophosphamide, bortezomib and dexamethasone (VCd) compared with VCd alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
Official title: A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone Versus Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Newly Diagnosed Systemic Light-Chain Amyloidosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2026-01-08
Completion Date
2028-12
Last Updated
2026-02-05
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
Dexamethasone
Pharmaceutical form: Tablets, ampoules or vials for injection; Route of administration: Oral/Intravenous
Cyclophosphamide
Pharmaceutical form: Tablets, ampoules or vials for injection; Route of administration: Oral/Intravenous
Locations (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China