This clinical trial is focused on studying a condition called AL amyloidosis, specifically in patients with a severe form known as Stage IIIb cardiac AL amyloidosis. This disease involves the buildup of abnormal proteins in the heart, which can lead to heart problems. The study is testing a new treatment called CAEL-101, also known by its code name anselamimab. This treatment is being compared to a placebo, which is a substance with no active medication, to see if it can improve the survival of patients who have not received any previous treatment for this condition.
Participants in the study will receive either the new treatment or a placebo, along with standard treatments for a related condition called plasma cell dyscrasia. The standard treatments include medications such as cyclophosphamide, bortezomib, and dexamethasone. These medications are commonly used to treat disorders involving abnormal plasma cells, which are a type of white blood cell. The study aims to determine if the combination of CAEL-101 and these standard treatments can help patients live longer and improve their quality of life.
The study will be conducted over a period of time, during which participants will receive their assigned treatments and be monitored for any changes in their health. The main goal is to assess the time it takes for any cause of death to occur from the start of the study. Additionally, the study will look at other health measures, such as heart function and physical activity levels, to evaluate the overall effectiveness and safety of the new treatment. Participants will be closely observed to ensure their safety throughout the study.
Austria 
Belgium 
Czechia 
France 
Germany 
Greece 
Italy 
Poland 
Spain 