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)
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
About This Trial
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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
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