Study Stopped
The VITAL study was terminated due to futility analysis
The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis
VITAL
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care Versus Placebo Plus Standard of Care in Subjects With Light Chain (AL) Amyloidosis
1 other identifier
interventional
260
14 countries
78
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2015
Typical duration for phase_3
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2014
CompletedFirst Posted
Study publicly available on registry
December 9, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedResults Posted
Study results publicly available
May 29, 2019
CompletedNovember 14, 2023
October 1, 2023
3.2 years
December 2, 2014
May 3, 2019
October 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Composite of All-cause Mortality or Cardiac Hospitalization
Time to all-cause mortality death occurring after the first infusion of study drug or cardiac hospitalization as adjudicated by the CEC occurring at least 91 days after first infusion of study drug through last subject last visit, whichever came first
Randomization until the date of death or cardiac hospitalization, up to 32 months
Study Arms (2)
NEOD001
EXPERIMENTAL24 mg/kg (maximum dose of 2500 mg) of NEOD001 administered once every 28 days.
Placebo
PLACEBO COMPARATORPlacebo will be administered as a 250 mL bag of normal saline once every 28 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (79)
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
St 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, 27599-1651, 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, 37232-5505, 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
Vienna, A-1090, Austria
ZNA Stuivenberg
Antwerp, 2060, Belgium
ULB Hopital Erasme
Brussels, 1070, Belgium
UZ Gasthuisberg
Leuven, 3000, Belgium
University of Calgary-Southern Alberta Cancer Research Institute
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 122, Canada
Princess Margaret Cancer Research Centre
Toronto, Ontario, M5G 1X6, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Rigshospitalet
Copenhagen, Denmark
Hopital de la Cote de Nacre Avenue
Caen, 14033, France
Hopital Henri Mondor
Créteil, 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-Bénite, 69495, France
Service d'Hermatologie CHU de Poitiers
Poitiers, 86000, France
CHU Rennes, Service de Medecine Interne
Rennes, 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
Pátrai, 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 GZ, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
MTZ Clinical Research Sp. z o.o.
Warsaw, 02-106, 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 2PF, United Kingdom
NNUH NHS Foundation Trust - Norfolk and Norwich University Hospital
Norwich, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Related Publications (1)
Gertz MA, Cohen AD, Comenzo RL, Kastritis E, Landau HJ, Libby EN, Liedtke M, Sanchorawala V, Schonland S, Wechalekar A, Zonder JA, Palladini G, Walling J, Guthrie S, Nie C, Karp C, Jin Y, Kinney GG, Merlini G. Birtamimab plus standard of care in light-chain amyloidosis: the phase 3 randomized placebo-controlled VITAL trial. Blood. 2023 Oct 5;142(14):1208-1218. doi: 10.1182/blood.2022019406.
PMID: 37366170DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wendy Curlin
- Organization
- Prothena Biosciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2014
First Posted
December 9, 2014
Study Start
February 1, 2015
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
November 14, 2023
Results First Posted
May 29, 2019
Record last verified: 2023-10