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The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis
Not Recruiting
Trial ID: NCT02312206
Purpose
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.
Official Title
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
Stanford Investigator(s)
Michaela Liedtke
Associate Professor of Medicine (Hematology)
Eligibility
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
Intervention(s):
drug: NEOD001
other: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061