TerminatedPhase 3

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

Stopped: The VITAL study was terminated due to futility analysis

United States260 participantsStarted 2015-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Time to Composite of All-cause Mortality or Cardiac Hospitalization

Timeframe: Randomization until the date of death or cardiac hospitalization, up to 32 months

Trial details

NCT IDNCT02312206

SponsorProthena Biosciences Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-05

Results submitted2019-05-03

View on ClinicalTrials.gov More Primary Systemic (AL) Amyloidosis trials