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