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Trial to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis.
THE MAIN REASON FOR CONDUCTING THIS STUDY IS TO TRY TO ANSWER THE FOLLOWING RESEARCH QUESTIONS: - DOES CAEL-101 HELP PEOPLE LIVE LONGER WHEN GIVEN WITH TREATMENT FOR AL AMYLOIDOSIS THAN TREATMENT FOR AL AMYLOIDOSIS ALONE? - DOES CAEL-101 IMPROVE THE FUNCTION OF ORGANS (SUCH AS THE HEART, LIVER, AND KIDNEYS) AFTER THEY HAVE BEEN AFFECTED BY AL AMYLOIDOSIS? - DOES CAEL-101 IMPROVE THE QUALITY OF LIFE OF PEOPLE WITH AL AMYLOIDOSIS?
Technical Summary
- PHASE III, DOUBLE-BLIND, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CAEL-101 AND TREATMENT FOR PLASMA CELL DYSCRASIA VS. PLACEBO AND TREATMENT FOR PLASMA CELL DYSCRASIA IN PATIENTS WITH MAYO CLINIC STAGE IIIA AL AMYLOIDOSIS WITH NO PRIOR TREATMENT FOR PLASMA CELL DYSCRASIA
- Code EudraCT: 2020-000713-32
- Protocol number: CAEL101-302
- Promoter: Caelum
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* 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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