The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis
Trial ID or NCT#
Status
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
- 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
- 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
Investigator(s)
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Contact
CCTO
650-498-7061
View on ClinicalTrials.gov