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

• Status: Terminated
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prothena Biosciences Ltd.; Prothena Therapeutics Ltd.

Criteria

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