A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis (CARES)

Phase 3 Active, not recruiting NCT04504825

Summary

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.

A Hierarchical Combination of Time to All-cause Mortality and Frequency of Cardiovascular Hospitalizations (CVHs) Analyzed by Win Ratio

Day 1 through end of the participant's PETP (Participants were enrolled on a rolling basis. Therefore, the primary analysis for the study was conducted 18-47 months after the study randomization.) · win ratio

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Day 1 through end of the participant's PETP (Participants were enrolled on a rolling basis. Therefore, the primary analysis for the study was conducted 18-47 months after the study randomization.) · Participants

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

• Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Mu — National Cancer Institute (NCI)
• Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Tr — National Cancer Institute (NCI)
• Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previo — National Cancer Institute (NCI)
• Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment fo — University of Michigan Rogel Cancer Center
• Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) a — University of Alabama at Birmingham
• Pembrolizumab in Treating Patients With Intermediate or High-Risk Smoldering Multiple Myel — M.D. Anderson Cancer Center

All trials