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

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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

Principal Investigator: Gareth J. Morgan.

Other Investigators: Maxim Kreditor, Marc Justin Braunstein, Sofia Aziz, Vathveal Mathews, Faith E. Davies, Bonnie Kiner-Strachan, Kenneth B Hymes, Michael L. Grossbard, John Leslie Vaughn, Oscar B Lahoud, Danny Perlaza, Gabrielle C Barshay, Ivy Mutibura, Shella Saint Fleur-Lominy, David Kaminetzky, Michael E Garrison, Tibor Moskovits, Bruce G Raphael, Thaleshravi Prashad.

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Perlmutter Cancer Center

Clinical Trials & Research Studies