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



Status:Terminated
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:6/10/2018
Start Date:February 2015
End Date:May 2018

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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

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.

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.

Key Inclusion Criteria:

1. Age ≥ 18 years

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

Key Exclusion Criteria:

1. Non-AL amyloidosis

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
We found this trial at
33
sites
Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Edward Libby, MD
Phone: 206-288-7140
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Raymond Comenzo, MD
Phone: 339-222-9307
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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72 East Concord Street
Boston, Massachusetts 02118
(617) 638-5300
Principal Investigator: Vaishali Sanchorawala, MD
Phone: 617-638-6519
Boston University School of Medicine A leader in medical education and research, Boston University School...
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Boston, MA
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Principal Investigator: Taimur Sher, MD
Phone: 855-776-0015
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Stacey Goodman, MD
Phone: 615-875-6120
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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630 W 168th St
New York, New York 10032
Principal Investigator: Suzanne Lentzsch, MD
Phone: 212-304-5485
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Brendan Weiss, MD
Phone: 215-662-3173
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Emma Scott, MD
Phone: 503-418-2086
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Principal Investigator: Jonathan Kaufman, MD
Phone: 404-778-1818
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Baltimore, Maryland 21287
Principal Investigator: Carol Ann Huff
Phone: 410-614-0675
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Box Hill,
Principal Investigator: Peter Schwarer, MD
Phone: (261) 390-9495 X02
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Chapel Hill, North Carolina 27599
Principal Investigator: Peter Voorhees, MD
Phone: 984-974-8659
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Charlotte, North Carolina 28211
Principal Investigator: Manisha Bhutani, MD
Phone: 980-442-2345
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Chicago, Illinois 60611
Principal Investigator: Seema Singhal, MD
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Chicago, Illinois 60637
Principal Investigator: Cara Rosenbaum, MD
Phone: 773-702-1835
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Cleveland, Ohio 44195
Principal Investigator: Jason Valent, MD
Phone: 216-445-6235
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
720-754-4800
Principal Investigator: Jeffrey Matous, MD
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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Detroit, Michigan 48201
Principal Investigator: Jeffrey Zonder, MD
Phone: 313-576-9381
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Duarte, California 91010
Principal Investigator: Michael Rosenzweig, MD
Phone: 626-256-4673
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Sascha Tuchman, MD
Phone: 919-688-5579
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Hans Lee, MD
Phone: 832-750-1446
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Indianapolis, Indiana 46202
Principal Investigator: Rafat Abonour, MD
Phone: 317-278-4840
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Miami, Florida 33312
Principal Investigator: James Hoffman, MD
Phone: 305-243-7648
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Milwaukee, Wisconsin 53226
Principal Investigator: Anita D'Souza, MD
Phone: 414-805-4594
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New Orleans, Louisiana 70121
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Heather Landau, MD
Phone: 646-449-1339
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Principal Investigator: Alice Cohen, MD
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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Pittsburgh, Pennsylvania 15232
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Rochester, Minnesota 55905
Principal Investigator: Morie Gertz, MD
Phone: 855-776-0015
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Saint Louis, Missouri 63110
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Salt Lake City, Utah 84112
Principal Investigator: Tibor Kovacsovics, MD
Phone: 801-585-0303
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Principal Investigator: Craig Reeder, MD
Phone: 855-776-0015
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Stanford, California 94305
Principal Investigator: Michaela Liedtke, MD
Phone: 650-723-0646
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