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
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

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