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

Protocol No

PROTHENA-NEOD001-301

Phase

III

Summary

The purpose of this study is to evaluate whether birtamimab, when given along with standard of
care chemotherapy, will improve survival in subjects with Mayo Stage IV AL amyloidosis.

Description

Birtamimab plus SOC vs Placebo plus SOC in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis

Participating Institutions

Froedtert Hospital

Status

OPEN TO ACCRUAL