Trial Search Results
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.
Stanford is currently not accepting patients for this trial.
Prothena Biosciences Ltd.
- Drug: NEOD001
- Other: Placebo
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
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study