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PRONTO NEOD001-201


Title A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction
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/NCT02632786

Overview

This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who had a hematologic response to previous treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT]) and have persistent cardiac dysfunction.

Study Details

Inclusion Criteria

  • Must have confirmed diagnosis of systemic AL amyloidosis
  • Must have had at least one prior systemic chemotherapeutic regimen for AL amyloidosis
  • Must have cardiac involvement

Exclusion Criteria

  • Must not have received Plasma cell directed chemotherapy within 6 months
  • Must not have received autologous stem cell transplant (ASCT) within 12 months
  • Must not have non-AL amyloidosis

Study Requirements

Subjects will be asked to provide blood samples in addition to standard of care labs at screening, every first day of a cycle, and at end of treatment. These samples will range in volume from about 3 tablespoons in volume to 1.5 tablespoons. Subjects will be asked to collect urine for 24 hours for a urine analysis. In addition, participants will be asked to fill out quality of life questionnaires and to do a six minute walk test. Treatment infusions will occur over 60 minutes, and it is estimated that subjects will be involved in the study for about 14 months.
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