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

Not Recruiting

Trial ID: NCT02632786

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

Stanford Investigator(s)

Michaela Liedtke
Michaela Liedtke

Associate Professor of Medicine (Hematology)

Eligibility


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

Intervention(s):

drug: NEOD001

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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