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.
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.
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
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There are 69 Locations for this study
Scottsdale Arizona, 85259, United States
Duarte California, 91010, United States
Stanford California, 94305, United States
Denver Colorado, 80218, United States
Jacksonville Florida, 32224, United States
Miami Florida, 33312, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46202, United States
New Orleans Louisiana, , United States
Baltimore Maryland, 21205, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02118, United States
Detroit Michigan, 48201, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Newark New Jersey, 07112, United States
New York New York, 10032, United States
New York New York, 10065, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28211, United States
Durham North Carolina, 27705, United States
Cleveland Ohio, 44195, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98109, United States
Milwaukee Wisconsin, 53226, United States
Box Hill , 3128, Australia
Sydney , 2145, Australia
Woolloongabba , 4102, Australia
Wien , A-109, Austria
Antwerpen , 2060, Belgium
Brussel , 1070, Belgium
Leuven , 3000, Belgium
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H3T 1, Canada
Copenhagen , , Denmark
Caen Cedex 9 , 14033, France
Creteil , 94010, France
Dijon , 21079, France
Limoges , 87042, France
Paris , 75013, France
Pierre-Benite Cedex , 69495, France
Poitiers , 86000, France
Rennes Cedex 2 , , France
Berlin , , Germany
Essen , 45122, Germany
Hamburg , 20246, Germany
Heidelberg , 69120, Germany
Athens , 11528, Greece
Patra , 26504, Greece
Jerusalem , 91120, Israel
Kfar Saba , 44281, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Bologna , 40138, Italy
Pavia , 27100, Italy
Rome , 00189, Italy
Groningen , 9713 , Netherlands
Utrecht , 3584 , Netherlands
Warszawa , 02-10, Poland
Pamplona Nevarra, , Spain
Badalona , 08916, Spain
Barcelona , 08036, Spain
Madrid , 28041, Spain
Madrid , 28222, Spain
Birmingham , , United Kingdom
Bristol , , United Kingdom
Leicester , , United Kingdom
London , NW3 2, United Kingdom
Norwich , , United Kingdom
Southampton , , United Kingdom
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