A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Light Chain (AL) Amyloidosis

In brief

A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.

Key facts

Study ID

NCT04973137

Run by

Prothena Biosciences Ltd.

People needed

208

Starts

2021-08-30

Expected to finish

2025-06-20

Last updated by the study team

2025-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Smilow Cancer Hospital Care Center at Trumbull — Trumbull, Connecticut, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Johns Hopkins University — Bethesda, Maryland, United States
• Boston University School of Med. — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States
• Perlmutter Cancer Center - 38th Street — New York, New York, United States
• Columbia University Irving Medical Center — New York, New York, United States
• New York University Langone Hospital - Long Island — New York, New York, United States
• Duke Clinical Research Institute — Durham, North Carolina, United States
• Cleveland Clinic Main Campus — Cleveland, Ohio, United States
• The Ohio State University College of Medicine — Columbus, Ohio, United States
• University of Tennessee Medical Center — Knoxville, Tennessee, United States
• Vanderbilt - Ingram Cancer Center - Henry-Joyce Cancer Clinic — Nashville, Tennessee, United States
• University of Washington — Seattle, Washington, United States
• Froedtert and Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• SESLHD: St George Hospital — Kogarah, New South Wales, Australia
• Royal Perth Hospital — Perth, Western Australia, Australia
• Paracelsus Medical University — Salzburg, State of Salzburg, Austria
• Yale Cancer Center — North Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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