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.

Lead Sponsor:

Prothena Therapeutics Ltd.

Stanford Investigator(s):

Intervention(s):

  • Drug: NEOD001
  • Other: Placebo

Phase:

Phase 3

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting