A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care Versus Placebo Plus Standard of Care in Subjects with Light Chain (AL) Amyloidosis

Protocol: 
AAAP5356
Phase: 
III

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care Versus Placebo Plus Standard of Care in Subjects with Light Chain (AL) Amyloidosis

The purpose of this study is to evaluate whether NEOD001 will improve survival in subjects with AL amyloidosis and/or increase the interval of time that they can go without requiring hospitalization for problems with their hearts. This study will also evaluate whether NEOD001 improves the function of subjects’ organs that have been affected by amyloid deposits.

Are you Eligible? (Inclusion Criteria)

Inclusion:
- Newly diagnosed and AL amyloidosis treatment naïve
- Bone marrow consistent with plasma cell dyscrasia within 42 days prior to Month 1-Day
- Planned first-line chemotherapy contains bortezomib administered weekly and SC

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States