Last updated on November 2016

The VITAL Amyloidosis Study a Global Phase 3 Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis


Brief description of study

This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm efficacy and safety study in subjects newly diagnosed with AL amyloidosis. Subjects will remain on-study until study completion, which will occur when all primary endpoint events (all-cause mortality or cardiac hospitalizations) have been reached.

Detailed Study Description

This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm efficacy and safety study in subjects newly diagnosed with AL amyloidosis. Approximately 236 subjects will be enrolled in ~60 centers, with approximately 118 subjects per arm. This is an event driven trial, therefore subjects will remain on-study until study completion, which will occur when all primary endpoint events (all-cause mortality or cardiac hospitalizations) have been reached. All subjects who discontinue will be followed until the last event is adjudicated. The estimated overall study duration is approximately 42 months, including the enrollment and treatment periods Study drug will be administered once every 28 days as a 60-120 minute IV infusion. First-line chemotherapy must be a proteasome inhibitor-containing regimen, with the proteasome inhibitor administered weekly. The number of cycles of first-line chemotherapy that are administered are at the discretion of the Investigator, and subsequent chemotherapy regimens may be prescribed as per standard of care at the Investigator's discretion. An independent Data Monitoring Committee (DMC) will review data on a regular basis.

Clinical Study Identifier: NCT02312206

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Craig Reeder, MD

Mayo Clinic Arizona
Scottsdale, AZ United States
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Michael Rosenzweig, MD

City of Hope
Duarte, CA United States
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Michaela Liedtke, MD

Stanford Cancer Institute (SCI)
Stanford, CA United States
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Jeffrey Matous, MD

Colorado Blood Cancer Institute
Denver, CO United States
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Taimur Sher, MD

Mayo Clinic
Jacksonville, FL United States
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James Hoffman, MD

Sylvester Cancer Center, University of Miami
Miami, FL United States
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Jonathan Kaufman, MD

Winship Cancer Institute of Emory University
Atlanta, GA United States
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Seema Singhal, MD

Radiant Research Northwestern University
Chicago, IL United States
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Cara Rosenbaum, MD

University of Chicago Medicine
Chicago, IL United States
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Rafat Abonour, MD

Indiana University Cancer Center
Indianapolis, IN United States
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Robert VB Emmons, MD

Ochsner Clinic Foundation
New Orleans, LA United States
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Carol Ann Huff

John Hopkins University School of Medicine
Baltimore, MD United States
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Raymond Comenzo, MD

Tufts Medical Center
Boston, MA United States
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Vaishali Sanchorawala, MD

Boston University School of Medicine
Boston, MA United States
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Jeffrey Zonder, MD

Karmanos Cancer Institute
Detroit, MI United States
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Morie Gertz, MD

Mayo Clinic
Rochester, MN United States
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Keith Stockerl-Goldstein, MD

Washington University in Saint Louis
St. Louis, MO United States
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Alice Cohen, MD

Newark Beth Israel Medical Center
Newark, NJ United States
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Suzanne Lentzsch, MD

Columbia University - College of Physicians & Surgeons
New York, NY United States
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Heather Landau, MD

Memorial Sloan-Kettering Cancer Center
New York, NY United States
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Peter Voorhees, MD

University of North Carolina Chapel Hill Comprehensive Cancer Center
Chapel Hill, NC United States
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Manisha Bhutani, MD

Levine Cancer Institute
Charlotte, NC United States
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Sascha Tuchman, MD

Duke University Medical Center
Durham, NC United States
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Jason Valent, MD

The Cleveland Clinic - Main Campus
Cleveland, OH United States
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Emma Scott, MD

Oregon Health & Science University
Portland, OR United States
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Brendan Weiss, MD

Hospital of the University of Pennsylvania
Philadelphia, PA United States
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Alison Sehgal, MD

University of Pittsburg - Hillman Cancer Center
Pittsburg, PA United States
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Stacey Goodman, MD

Vanderbilt University Medical Center
Nashville, TN United States
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Hans Lee, MD

University of Texas; MD Anderson Cancer Center
Houston, TX United States
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Tibor Kovacsovics, MD

Huntsman Cancer Institute
Salt Lake City, UT United States
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Edward Libby, MD

University of Washington
Seattle, WA United States
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Anita D'Souza, MD

Froedtert & Medical College of Wisconsin, Cancer Center-Froedtert Hospital
Milwaukee, WI United States
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Peter Schwarer, MD

Eastern Health (Box Hill Hospital)
Box Hill, Australia
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Fiona Kwok, MD

Amyloidosis Clinic Cnr Darcy Road and Bridge St. Westmead
Sydney, Australia
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Peter Mollee, MD

The University of Queensland-Princess Alexandra Hospital (PAH)
Wooloongabba, Australia
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Hemine Agis, MD

Universitatsklinik fur Innere Medizin 1 Kinische Abteilung fur Onkologie Aligemeines Krankenhaus - Universitatskliniken
Wien, Austria
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Ka Lung Wu, MD

ZNA Stuivenberg
Antwerpen, Belgium
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Virginie De Wilde, MD

ULB Hopital Erasme
Brussel, Belgium
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Michel Delforge, MD

UZ Gasthuisberg
Leuven, Belgium
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Victor Zepeda, MD

University of Calgary-Southern Alberta Cancer Research Institute
Calgary, AB Canada
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Chris Venner, MD

Cross Cancer Institute
Edmonton, AB Canada
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Vishal Kukreti, MD

Princess Margaret Cancer Research Centre
Toronto, ON Canada
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Martin Gyger, MD

Jewish General Hospital
Montreal, QC Canada
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Morten Salomo

Rigshospitalet
Copenhagen, Denmark
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Margaret Macro, MD

Hopital de la Cote de Nacre Avenue
Caen Cedex 9, France
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Karim Belhadj, MD

Hopital Henri Mondor
Creteil, France
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Denis Caillot, MD

CHU Dijon - Hopital du Bocage
Dijon, France
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Arnaud Jaccard, MD

H pital Dupuytren - CHU Limoges
Limoges, France
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Sylvain Choquet, MD

H pital Piti -Salp tri re
Paris, France
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Lionel Karlin, MD

Hopitaux Lyon Sud
Pierre-Benite Cedex, France
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Frank Bridoux, MD

Service d'Hermatologie CHU de Poitiers
Poitiers, France
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Olivier Decaux, MD

CHU Rennes, Service de Medecine Interne
Rennes Cedex 2, France
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Axel Nogal, MD

Charite-Universitatsmedizin
Berlin, Germany
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Alexander Carpinteiro, MD

Universit tsklinikum Essen
Essen, Germany
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Timon Hansen, MD

Universitatsklinikum Hamburg-Eppendorf (UKE)
Hamburg, Germany
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