The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis

Trial ID or NCT#

NCT02632786

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official 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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Age ≥18 years 2. Confirmed diagnosis of systemic AL amyloidosis 3. ≥1 prior systemic plasma cell dyscrasia therapy with at least a partial hematologic response 4. Cardiac involvement 5. NT-proBNP ≥650
Exclusion Criteria:
  1. 1. Non-AL amyloidosis 2. Meets the International Myeloma Working Group (IMWG) definition of Multiple Myeloma 3. NT-proBNP >5000 4. Received Plasma cell directed chemotherapy within 6 months 5. Received autologous stem cell transplant (ASCT) within 12 months
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Investigator(s)

Michaela Liedtke
Michaela Liedtke
Hematologist-Oncologist
Associate Professor of Medicine (Hematology)

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Contact

CCTO
650-498-7061

View on ClinicalTrials.gov