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A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment NaÃ¯ve Patients With Mayo Stage IIIb AL Amyloidosis
Caelum Biosciences, Inc.
This is a randomised, double-blind trial with two arms. In the Experimental Arm, participants will receive CAEL-101, administered as an intravenous (IV) infusion and also receive Standard of Care plasma cell dyscrasia. In the Placebo Comparator Arm, participants will receive a placebo, administered via IV, and also receive Standard of Care plasma cell dyscrasia. The minimum planned treatment time for each participant is 50 weeks. The Standard of Care treatment for Plasma Cell Dyscrasia that all participants receives will consist of a cyclophosphamide, bortezomib, and dexamethasone (CyBorD) regimen.