AL Amyloidosis Clinical Trial

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

Summary

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.

View Full Description

Full 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 bortezomib-containing regimen, with bortezomib 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.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Age ≥ 18 years
Newly diagnosed, AL amyloidosis treatment naïve
Bone marrow consistent with plasma cell dyscrasia
Confirmed diagnosis of AL amyloidosis
Cardiac involvement
Planned first-line chemotherapy contains a proteasome-inhibiting agent administered weekly
Adequate bone marrow reserve, hepatic and renal function

Key Exclusion Criteria:

Non-AL amyloidosis
Meets diagnostic criteria for symptomatic multiple myeloma
Subject is eligible for and plans to undergo ASCT
History of Grade ≥ 3 infusion-associated AEs or hypersensitivity to another monoclonal antibody, or known hypersensitivity to diphenhydramine or acetaminophen

Study is for people with:

AL Amyloidosis

Phase:

Phase 3

Estimated Enrollment:

260

Study ID:

NCT02312206

Recruitment Status:

Terminated

Sponsor:

Prothena Biosciences Ltd.

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There are 69 Locations for this study

See Locations Near You

Mayo Clinic Arizona
Scottsdale Arizona, 85259, United States
City of Hope
Duarte California, 91010, United States
Stanford Cancer Institute (SCI)
Stanford California, 94305, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Mayo Clinic
Jacksonville Florida, 32224, United States
Sylvester Cancer Center, University of Miami
Miami Florida, 33312, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
Radiant Research Northwestern University
Chicago Illinois, 60611, United States
University of Chicago Medicine
Chicago Illinois, 60637, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
Ochsner Clinic Foundation
New Orleans Louisiana, , United States
John Hopkins University School of Medicine
Baltimore Maryland, 21205, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
Boston University School of Medicine
Boston Massachusetts, 02118, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Washington University in Saint Louis
Saint Louis Missouri, 63110, United States
Newark Beth Israel Medical Center
Newark New Jersey, 07112, United States
Columbia University - College of Physicians & Surgeons
New York New York, 10032, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
University of North Carolina Chapel Hill Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States
Levine Cancer Institute
Charlotte North Carolina, 28211, United States
Duke University Medical Center
Durham North Carolina, 27705, United States
The Cleveland Clinic - Main Campus
Cleveland Ohio, 44195, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
University of Pittsburg - Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
University of Texas; MD Anderson Cancer Center
Houston Texas, 77030, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
University of Washington
Seattle Washington, 98109, United States
Froedtert & Medical College of Wisconsin, Cancer Center-Froedtert Hospital
Milwaukee Wisconsin, 53226, United States
Eastern Health (Box Hill Hospital)
Box Hill , 3128, Australia
Amyloidosis Clinic Cnr Darcy Road and Bridge St. Westmead
Sydney , 2145, Australia
The University of Queensland-Princess Alexandra Hospital (PAH)
Woolloongabba , 4102, Australia
Universitatsklinik fur Innere Medizin 1 Kinische Abteilung fur Onkologie Aligemeines Krankenhaus - Universitatskliniken
Wien , A-109, Austria
ZNA Stuivenberg
Antwerpen , 2060, Belgium
ULB Hopital Erasme
Brussel , 1070, Belgium
UZ Gasthuisberg
Leuven , 3000, Belgium
University of Calgary-Southern Alberta Cancer Research Institute
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Princess Margaret Cancer Research Centre
Toronto Ontario, M5G 1, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Rigshospitalet
Copenhagen , , Denmark
Hopital de la Cote de Nacre Avenue
Caen Cedex 9 , 14033, France
Hopital Henri Mondor
Creteil , 94010, France
CHU Dijon - Hopital du Bocage
Dijon , 21079, France
Hôpital Dupuytren - CHU Limoges
Limoges , 87042, France
Hôpital Pitié-Salpêtrière
Paris , 75013, France
Hopitaux Lyon Sud
Pierre-Benite Cedex , 69495, France
Service d'Hermatologie CHU de Poitiers
Poitiers , 86000, France
CHU Rennes, Service de Medecine Interne
Rennes Cedex 2 , , France
Charite-Universitatsmedizin
Berlin , , Germany
Universitätsklinikum Essen
Essen , 45122, Germany
Universitatsklinikum Hamburg-Eppendorf (UKE)
Hamburg , 20246, Germany
Universitatsklinikum Heidelberg
Heidelberg , 69120, Germany
Alexandra General Hospital of Athens
Athens , 11528, Greece
University Hospital of Patras
Patra , 26504, Greece
Hadassah University Medical Center
Jerusalem , 91120, Israel
Meir Medical Center
Kfar Saba , 44281, Israel
The Chaim Sheba Medical Center
Ramat Gan , 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Policlinico S.Orsola Malpighi, Unita' Operativa di Ematologia
Bologna , 40138, Italy
Policlinica San Matteo
Pavia , 27100, Italy
Azienda Ospedaliera Sant'Andrea, U.O.S.
Rome , 00189, Italy
University Medical Center Groningen
Groningen , 9713 , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht , 3584 , Netherlands
MTZ Clinical Research Sp. z o.o.
Warszawa , 02-10, Poland
Clínica Universidad de Navarra
Pamplona Nevarra, , Spain
Hospital Universitari Germans Trias i Pujol
Badalona , 08916, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario Puerta de Hierro - Maiadahonda
Madrid , 28222, Spain
University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
Birmingham , , United Kingdom
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre
Bristol , , United Kingdom
Leicester Royal Infirmary
Leicester , , United Kingdom
The Royal Free London NHS Foundation Trust-The Royal Free Hospital
London , NW3 2, United Kingdom
NNUH NHS Foundation Trust - Norfolk and Norwich University Hospital
Norwich , , United Kingdom
Southampton General Hospital
Southampton , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

AL Amyloidosis

Phase:

Phase 3

Estimated Enrollment:

260

Study ID:

NCT02312206

Recruitment Status:

Terminated

Sponsor:


Prothena Biosciences Ltd.

How clear is this clinincal trial information?

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