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

Completed · Phase 2 · Has a placebo group

Conditions studied: AL Amyloidosis

In brief

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.

Key facts

Study ID

NCT02632786

Run by

Prothena Biosciences Ltd.

People needed

129

Starts

2016-03-01

Expected to finish

2018-03-01

Last updated by the study team

2019-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope — Duarte, California, United States
• Stanford Cancer Institute (SCI) — Stanford, California, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• Mayo Clinic — Jacksonville, Florida, United States
• University of Chicago Medicine — Chicago, Illinois, United States
• Indiana University Simon Cancer Center — Indianapolis, Indiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Boston University School of Medicine — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic - Minnesota — Rochester, Minnesota, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas; MD Anderson Cancer Center — Houston, Texas, United States
• University of Washington/Seattle Cancer Care Alliance — Seattle, Washington, United States
• Froedtert & Medical College of Wisconsin, Cancer Center - Froedtert Hospital — Milwaukee, Wisconsin, United States
• Westmead Hospital — Sydney, New South Wales, Australia
• The University of Queensland - Princess Alexandra Hospital (PAH) — Woolloongabba, Queensland, Australia
• Eastern Health (Box Hill Hospital) — Box Hill, Victoria, Australia
• Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien — Vienna, Austria
• Hôpital Dupuytren - CHU Limoges — Limoges, France
• Hôpital Pitié-Salpêtrière — Paris, France

Full record on ClinicalTrials.gov

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