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

 Exclusion Criteria:

 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