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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02312206
• Date of registration: 02/12/2014
• Prospective Registration: Yes
• Primary sponsor: Prothena Therapeutics Ltd.
• Public title: The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis VITAL
• Scientific 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
• Date of first enrolment: February 2015
• Target sample size: 260
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02312206
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Netherlands, Poland, Spain, United Kingdom, United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Primary Systemic (AL) Amyloidosis

Intervention(s)

Drug: NEOD001

Other: Placebo

Primary Outcome(s)

Time to Composite of All-cause Mortality or Cardiac Hospitalization [Time Frame: Randomization until the date of death or cardiac hospitalization, up to 32 months]

Secondary ID(s)

NEOD001-CL002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/05/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02312206