Last updated on June 2018

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

Contact Investigators or Research Sites near you

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Craig Reeder, MD

Mayo Clinic Arizona
Scottsdale, AZ United States

Michael Rosenzweig, MD

City of Hope
Duarte, CA United States

Michaela Liedtke, MD

Stanford Cancer Institute (SCI)
Stanford, CA United States

Jeffrey Matous, MD

Colorado Blood Cancer Institute
Denver, CO United States

Taimur Sher, MD

Mayo Clinic
Jacksonville, FL United States

James Hoffman, MD

Sylvester Cancer Center, University of Miami
Miami, FL United States

Jonathan Kaufman, MD

Winship Cancer Institute of Emory University
Atlanta, GA United States

Seema Singhal, MD

Radiant Research Northwestern University
Chicago, IL United States

Cara Rosenbaum, MD

University of Chicago Medicine
Chicago, IL United States

Rafat Abonour, MD

Indiana University Cancer Center
Indianapolis, IN United States

Robert VB Emmons, MD

Ochsner Clinic Foundation
New Orleans, LA United States

Carol Ann Huff

John Hopkins University School of Medicine
Baltimore, MD United States

Raymond Comenzo, MD

Tufts Medical Center
Boston, MA United States

Vaishali Sanchorawala, MD

Boston University School of Medicine
Boston, MA United States

Jeffrey Zonder, MD

Karmanos Cancer Institute
Detroit, MI United States

Morie Gertz, MD

Mayo Clinic
Rochester, MN United States

Keith Stockerl-Goldstein, MD

Washington University in Saint Louis
St. Louis, MO United States

Alice Cohen, MD

Newark Beth Israel Medical Center
Newark, NJ United States

Suzanne Lentzsch, MD

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

Heather Landau, MD

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

Peter Voorhees, MD

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

Manisha Bhutani, MD

Levine Cancer Institute
Charlotte, NC United States

Sascha Tuchman, MD

Duke University Medical Center
Durham, NC United States

Jason Valent, MD

The Cleveland Clinic - Main Campus
Cleveland, OH United States

Emma Scott, MD

Oregon Health & Science University
Portland, OR United States

Brendan Weiss, MD

Hospital of the University of Pennsylvania
Philadelphia, PA United States

Alison Sehgal, MD

University of Pittsburg - Hillman Cancer Center
Pittsburg, PA United States

Stacey Goodman, MD

Vanderbilt University Medical Center
Nashville, TN United States

Hans Lee, MD

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

Tibor Kovacsovics, MD

Huntsman Cancer Institute
Salt Lake City, UT United States

Edward Libby, MD

University of Washington
Seattle, WA United States

Anita D'Souza, MD

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

Peter Schwarer, MD

Eastern Health (Box Hill Hospital)
Box Hill, Australia

Fiona Kwok, MD

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

Peter Mollee, MD

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

Hemine Agis, MD

Universitatsklinik fur Innere Medizin 1 Kinische Abteilung fur Onkologie Aligemeines Krankenhaus - Universitatskliniken
Wien, Austria

Ka Lung Wu, MD

ZNA Stuivenberg
Antwerpen, Belgium

Virginie De Wilde, MD

ULB Hopital Erasme
Brussel, Belgium

Michel Delforge, MD

UZ Gasthuisberg
Leuven, Belgium

Victor Zepeda, MD

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

Chris Venner, MD

Cross Cancer Institute
Edmonton, AB Canada

Vishal Kukreti, MD

Princess Margaret Cancer Research Centre
Toronto, ON Canada

Martin Gyger, MD

Jewish General Hospital
Montreal, QC Canada

Morten Salomo

Rigshospitalet
Copenhagen, Denmark

Margaret Macro, MD

Hopital de la Cote de Nacre Avenue
Caen Cedex 9, France

Karim Belhadj, MD

Hopital Henri Mondor
Creteil, France

Denis Caillot, MD

CHU Dijon - Hopital du Bocage
Dijon, France

Arnaud Jaccard, MD

H pital Dupuytren - CHU Limoges
Limoges, France

Sylvain Choquet, MD

H pital Piti -Salp tri re
Paris, France

Lionel Karlin, MD

Hopitaux Lyon Sud
Pierre-Benite Cedex, France

Frank Bridoux, MD

Service d'Hermatologie CHU de Poitiers
Poitiers, France

Olivier Decaux, MD

CHU Rennes, Service de Medecine Interne
Rennes Cedex 2, France

Axel Nogal, MD

Charite-Universitatsmedizin
Berlin, Germany

Alexander Carpinteiro, MD

Universit tsklinikum Essen
Essen, Germany

Timon Hansen, MD

Universitatsklinikum Hamburg-Eppendorf (UKE)
Hamburg, Germany

Recruitment Status: Closed


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