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Clinical trial of birtamimab in patients with stage IV light chain amyloidosis at the Mayo Clinic

THE PURPOSE OF THIS STUDY IS TO EVALUATE WHETHER BIRTAMIMAB WILL IMPROVE SURVIVAL IN PATIENTS WITH STAGE IV AL AMYLOIDOSIS AT THE MAYO CLINIC. THIS IS A RELATIVELY RARE BLOOD DISEASE IN WHICH ABNORMAL PROTEIN DEPOSITS, CALLED AMYLOID, CAN ACCUMULATE IN ORGANS AND CAUSE PROGRESSIVE DAMAGE SO THAT THEY NO LONGER FUNCTION PROPERLY. ORGANS THAT MAY BE AFFECTED INCLUDE THE HEART, KIDNEYS, LIVER, SPLEEN, DIGESTIVE OR GASTROINTESTINAL TRACT AND NERVOUS SYSTEM.

Cancer Center
Status
In recruitment
headquarters
Pamplona/Madrid

Technical Summary

  • PHASE 3, RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF BIRTAMIMAB ADDED TO STANDARD THERAPY COMPARED TO PLACEBO ADDED TO STANDARD THERAPY IN PATIENTS WITH STAGE IV LIGHT-CHAIN AMYLOIDOSIS (AL) AT THE MAYO CLINIC. IMMUNOTHERAPY
  • Code EudraCT: 2021-000037-14
  • Protocol number: NEOD001-301
  • Promoter: Prothema Biosciences Limited

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

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