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The Vital Amyloidosis Study, a Phase 3, Multicenter Efficacy and Safety Study of NEOD001


Title 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
Therapeutic Area Amyloidosis
Principal Investigator Raymond Comenzo, MD
Min Age 18 Years
Gender Both
Contact George Mensing
617-636-2683
More Information https://clinicaltrials.gov/ct2/show/NCT02312206

Overview

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.

Study Details

Inclusion Criteria

  • Newly diagnosed AL amyloidosis with cardiac involvement
  • Otherwise normal organ function

Exclusion Criteria

  • 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.

Study Requirements

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.
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