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

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ClinicalTrials.gov Identifier: NCT02312206
Recruitment Status : Terminated (The VITAL study was terminated due to futility analysis)
First Posted : December 9, 2014
Results First Posted : May 29, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Prothena Therapeutics Ltd.

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 until study completion, which will occur when all primary endpoint events (all-cause mortality or cardiac hospitalizations) have been reached.

Condition or disease Intervention/treatment Phase
Primary Systemic (AL) Amyloidosis Drug: NEOD001 Other: Placebo Phase 3

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 be enrolled in ~60 centers, with approximately 118 subjects per arm.

This is an event driven trial, therefore 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. All subjects who discontinue will be followed until the last event is adjudicated. The estimated overall study duration is approximately 42 months, including the enrollment and treatment periods

Study drug will be administered once every 28 days as a 60-120 minute IV infusion.

First-line chemotherapy must be a bortezomib-containing regimen, with bortezomib administered weekly. The number of cycles of first-line chemotherapy that are administered are at the discretion of the Investigator, and subsequent chemotherapy regimens may be prescribed as per standard of care at the Investigator's discretion.

An independent Data Monitoring Committee (DMC) will review data on a regular basis.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

Arm Intervention/treatment
Experimental: NEOD001
24 mg/kg (maximum dose of 2500 mg) of NEOD001 administered once every 28 days.
Drug: NEOD001
NEOD001, is a humanized immunoglobulin G1 monoclonal antibody, which specifically targets misfolded light chain aggregates and amyloid deposits. NEOD001 is proposed for use to target the misfolded light chain protein in subjects with AL amyloidosis.

Placebo Comparator: Placebo
Placebo will be administered as a 250 mL bag of normal saline once every 28 days.
Other: Placebo
Placebo




Primary Outcome Measures :
  1. 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 ]
    Time to all-cause mortality death occurring after the first infusion of study drug or cardiac hospitalization as adjudicated by the CEC occurring at least 91 days after first infusion of study drug through last subject last visit, whichever came first



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02312206


  Show 79 Study Locations
Sponsors and Collaborators
Prothena Therapeutics Ltd.
  Study Documents (Full-Text)

Documents provided by Prothena Therapeutics Ltd.:
Study Protocol  [PDF] November 6, 2017
Statistical Analysis Plan  [PDF] June 13, 2018


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Responsible Party: Prothena Therapeutics Ltd.
ClinicalTrials.gov Identifier: NCT02312206     History of Changes
Other Study ID Numbers: NEOD001-CL002
First Posted: December 9, 2014    Key Record Dates
Results First Posted: May 29, 2019
Last Update Posted: June 12, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases