AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract. The primary purpose of this study is to determine whether CAEL-101, a monoclonal antibody that removes AL amyloid deposits from tissues and organs, improves overall survival, reduces cardiovascular related hospitalizations and it is safe and well tolerated in patients with stage IIIb AL amyloidosis.
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A hierarchical combination of Time to All-cause Mortality and Frequency of Cardiovascular hospitalizations
Timeframe: From the date of randomization to date of death or Primary Evaluation Treatment Period (PETP) (up to 51 months)
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Timeframe: From date of randomization to Primary Evaluation Treatment Period (PETP) (up to 56 months)