The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis
NCT ID: NCT02632786
Last Updated: 2019-04-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
129 participants
INTERVENTIONAL
2016-03-31
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NEOD001
Study Drug given IV every 28 days at 24mg/kg
NEOD001
NEOD001 is a monoclonal antibody directed at soluble and insoluble light chain aggregates
Placebo
Placebo
Placebo
Saline Bag
Interventions
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NEOD001
NEOD001 is a monoclonal antibody directed at soluble and insoluble light chain aggregates
Placebo
Saline Bag
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Prothena Biosciences Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Hopitaux Lyon Sud
Pierre-Bénite, , France
CHU Rennes, Service de Medecine Interne
Rennes, , France
Charite-Universitatsmedizin
Berlin, , Germany
Universitätsklinikum Essen
Essen, , Germany
Universitatsklinikum Hamburg-Eppendorf (UKE
Hamburg, , Germany
Universitatsklinikum Heidelberg
Heidelberg, , Germany
Alexandra General Hospital of Athens
Athens, , Greece
University Hospital of Patras
Pátrai, , Greece
Hadassah University Medical Center
Jerusalem, , Israel
Policlinica San Matteo
Pavia, , Italy
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, , Spain
Centre for Clinical Haematology
Birmingham, , United Kingdom
The Royal Free London NHS Foundation Trust - The Royal Free Hospital
London, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NEOD001-201
Identifier Type: -
Identifier Source: org_study_id
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