TERMINATED

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

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Conditions

Light Chain (AL) AmyloidosisMayo Stage IVbirtamimab

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects With Light Chain (AL) Amyloidosis

Quick Facts

Study Start:2021-08-30
Study Completion:2025-06-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04973137

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Yale Cancer Center
North Haven, Connecticut, 06473
United States
Smilow Cancer Hospital Care Center at Trumbull
Trumbull, Connecticut, 06611
United States
MedStar Georgetown University Hospital
Washington, District of Columbia, 20007
United States
Cleveland Clinic Florida
Weston, Florida, 33331
United States
Johns Hopkins University
Bethesda, Maryland, 20814-1422
United States
Boston University School of Med.
Boston, Massachusetts, 02118
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68105
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
United States
Perlmutter Cancer Center - 38th Street
New York, New York, 10016
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
New York University Langone Hospital - Long Island
New York, New York, 11501
United States
Duke Clinical Research Institute
Durham, North Carolina, 27705
United States
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
United States
The Ohio State University College of Medicine
Columbus, Ohio, 43210
United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States
Vanderbilt - Ingram Cancer Center - Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
United States
University of Washington
Seattle, Washington, 98109
United States
Froedtert and Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Prothena Biosciences Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-30
Study Completion Date2025-06-20

Study Record Updates

Study Start Date2021-08-30
Study Completion Date2025-06-20

Terms related to this study

Keywords Provided by Researchers

  • Light Chain (AL) Amyloidosis
  • Mayo Stage IV
  • birtamimab

Additional Relevant MeSH Terms

  • Light Chain (AL) Amyloidosis