Multiple Myeloma Clinical Trial
The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis
Summary
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.
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years
Confirmed diagnosis of systemic AL amyloidosis
≥1 prior systemic plasma cell dyscrasia therapy with at least a partial hematologic response
Cardiac involvement
NT-proBNP ≥650
Exclusion Criteria:
Non-AL amyloidosis
Meets the International Myeloma Working Group (IMWG) definition of Multiple Myeloma
NT-proBNP >5000
Received Plasma cell directed chemotherapy within 6 months
Received autologous stem cell transplant (ASCT) within 12 months
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