A Phase 3 Randomized Multicenter Double-Blind Placebo-Controlled Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis
Brief description of study
This is a multicenter, global, randomized, double-blind, placebocontrolled, efficacy and safety study in Mayo Stage IV subjects with AL amyloidosis. Newly diagnosed Mayo Stage IV subjects with AL amyloidosis will be randomized in a 2:1 ratio to birtamimab or placebo. The initial first-line chemotherapy regimen must include bortezomib.
Clinical Study Identifier: s20-01912
ClinicalTrials.gov Identifier: NCT04973137
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