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

Go Back to All Clinical Trials

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

Brief description of study

This is a multicenter, global, randomized, double-blind, placebocontrolled, efficacy and safety study in Mayo Stage IV subjects with AL amyloidosis. Newly diagnosed Mayo Stage IV subjects with AL amyloidosis will be randomized in a 2:1 ratio to birtamimab or placebo. The initial first-line chemotherapy regimen must include bortezomib.

Clinical Study Identifier: s20-01912

ClinicalTrials.gov Identifier: NCT04973137

Principal Investigator: Gareth J. Morgan.

Other Investigators: Kenneth B Hymes, Marc Justin Braunstein, Sofia Aziz, Vathveal Mathews, Faith E. Davies, Bonnie Kiner-Strachan, Maxim Kreditor, John Leslie Vaughn, Oscar B Lahoud, Danny Perlaza, Gabrielle C Barshay, Michael L. Grossbard, Shella Saint Fleur-Lominy, David Kaminetzky, Michael E Garrison, Tibor Moskovits, Bruce G Raphael, Ivy Mutibura, Thaleshravi Prashad.

Contact the research team to learn more about this study.

Your Email

Not a valid e-mail address

Please Provide Email Address

First Name

First name is mandatory

Last Name

Your Phone

Please provide phone number

Invalid phone number

Valid phone number

Comments

Send Confirmation of This To Me

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.

Perlmutter Cancer Center

Clinical Trials & Research Studies