Back to Results
The Vital Amyloidosis Study, a Phase 3, Multicenter Efficacy and Safety Study of NEOD001
||A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care vs. Placebo Plus Standard of Care in Subjects with Light Chain (AL) Amyloidosis
||Raymond Comenzo, MD
The purpose of this study is to evaluate whether NEOD001, the study drug, 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.
- Newly diagnosed AL amyloidosis with cardiac involvement
- Otherwise normal organ function
- No pregnant or nusing women
- No prior treatment
- No subjects with complicating malignancies or diseases such as symptomatic multiple myeloma, symptomatic orthstatic hypotension (low blood pressure), or severe congenital heart disease.
To determine if potential subjects can be in the study, they must come to the hospital for 2 clinic visits for screening. The screening visits include a normal physical exam by a doctor, medical tests, and a questionnaire about health and lifestyle. Subjects will fill out questionnaires about health and lifestyle every 3 months. Subjects will come to the hospital to receive chemotherapy as they would if they weren’t in the study. Subjects will come to the hospital to receive study drug infusion once a month until the study ends. After the study ends, subjects will be asked to come to the hospital for a follow up visit to check for side effects of the study drug. If subjects agree, extra blood will be collected – 3 ml (less than a teaspoon) every month – during the study for future research.
Are you interested in learning more about this clinical trial?
Send us a message and we'll get back to you with more information.