Status:
TERMINATED
The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis
Lead Sponsor:
Prothena Biosciences Ltd.
Conditions:
Primary Systemic (AL) Amyloidosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 un...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Key
- Age ≥ 18 years
- Newly diagnosed, AL amyloidosis treatment naïve
- Bone marrow consistent with plasma cell dyscrasia
- Confirmed diagnosis of AL amyloidosis
- Cardiac involvement
- Planned first-line chemotherapy contains a proteasome-inhibiting agent administered weekly
- Adequate bone marrow reserve, hepatic and renal function
- Key
Exclusion
- Non-AL amyloidosis
- Meets diagnostic criteria for symptomatic multiple myeloma
- Subject is eligible for and plans to undergo ASCT
- History of Grade ≥ 3 infusion-associated AEs or hypersensitivity to another monoclonal antibody, or known hypersensitivity to diphenhydramine or acetaminophen
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT02312206
Start Date
February 1 2015
End Date
May 1 2018
Last Update
November 14 2023
Active Locations (79)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
2
City of Hope
Duarte, California, United States, 91010
3
Stanford Cancer Institute (SCI)
Stanford, California, United States, 94305
4
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218