The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis
NCT ID: NCT02312206
Last Updated: 2023-11-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
260 participants
INTERVENTIONAL
2015-02-28
2018-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study in Subjects With Light Chain (AL) Amyloidosis
NCT03154047
Phase 1/2, Open Label, Dose Escalation Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis
NCT01707264
Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis
NCT02613182
Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis
NCT00030381
A Study to Characterize the Biodistribution of 124I-Labeled AT-03 in Patients With Systemic Amyloidosis
NCT05201911
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NEOD001
24 mg/kg (maximum dose of 2500 mg) of NEOD001 administered once every 28 days.
NEOD001
NEOD001, is a humanized immunoglobulin G1 monoclonal antibody, which specifically targets misfolded light chain aggregates and amyloid deposits. NEOD001 is proposed for use to target the misfolded light chain protein in subjects with AL amyloidosis.
Placebo
Placebo will be administered as a 250 mL bag of normal saline once every 28 days.
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NEOD001
NEOD001, is a humanized immunoglobulin G1 monoclonal antibody, which specifically targets misfolded light chain aggregates and amyloid deposits. NEOD001 is proposed for use to target the misfolded light chain protein in subjects with AL amyloidosis.
Placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Newly diagnosed, AL amyloidosis treatment naïve
3. Bone marrow consistent with plasma cell dyscrasia
4. Confirmed diagnosis of AL amyloidosis
5. Cardiac involvement
6. Planned first-line chemotherapy contains a proteasome-inhibiting agent administered weekly
7. Adequate bone marrow reserve, hepatic and renal function
Exclusion Criteria
2. Meets diagnostic criteria for symptomatic multiple myeloma
3. Subject is eligible for and plans to undergo ASCT
4. History of Grade ≥ 3 infusion-associated AEs or hypersensitivity to another monoclonal antibody, or known hypersensitivity to diphenhydramine or acetaminophen
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Prothena Biosciences Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic Arizona
Scottsdale, Arizona, United States
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
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Radiant Research Northwestern University
Chicago, Illinois, United States
University of Chicago Medicine
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
John Hopkins University School of Medicine
Baltimore, Maryland, 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
Rochester, Minnesota, United States
Washington University in Saint Louis
St Louis, Missouri, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Columbia University - College of Physicians & Surgeons
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
University of North Carolina Chapel Hill Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
The Cleveland Clinic - Main Campus
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburg - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas; MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
University of Washington
Seattle, Washington, United States
Froedtert & Medical College of Wisconsin, Cancer Center-Froedtert Hospital
Milwaukee, Wisconsin, United States
Eastern Health (Box Hill Hospital)
Box Hill, , Australia
Amyloidosis Clinic Cnr Darcy Road and Bridge St. Westmead
Sydney, , Australia
The University of Queensland-Princess Alexandra Hospital (PAH)
Woolloongabba, , Australia
Universitatsklinik fur Innere Medizin 1 Kinische Abteilung fur Onkologie Aligemeines Krankenhaus - Universitatskliniken
Vienna, , Austria
ZNA Stuivenberg
Antwerp, , Belgium
ULB Hopital Erasme
Brussels, , Belgium
UZ Gasthuisberg
Leuven, , Belgium
University of Calgary-Southern Alberta Cancer Research Institute
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Princess Margaret Cancer Research Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Rigshospitalet
Copenhagen, , Denmark
Hopital de la Cote de Nacre Avenue
Caen, , France
Hopital Henri Mondor
Créteil, , France
CHU Dijon - Hopital du Bocage
Dijon, , France
Hôpital Dupuytren - CHU Limoges
Limoges, , France
Hôpital Pitié-Salpêtrière
Paris, , France
Hopitaux Lyon Sud
Pierre-Bénite, , France
Service d'Hermatologie CHU de Poitiers
Poitiers, , 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
Meir Medical Center
Kfar Saba, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Policlinico S.Orsola Malpighi, Unita' Operativa di Ematologia
Bologna, , Italy
Policlinica San Matteo
Pavia, , Italy
Azienda Ospedaliera Sant'Andrea, U.O.S.
Rome, , Italy
University Medical Center Groningen
Groningen, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
MTZ Clinical Research Sp. z o.o.
Warsaw, , Poland
Clínica Universidad de Navarra
Pamplona, Nevarra, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Puerta de Hierro - Maiadahonda
Madrid, , 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, , United Kingdom
NNUH NHS Foundation Trust - Norfolk and Norwich University Hospital
Norwich, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NEOD001-CL002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.