A Study to Evaluate the Effectiveness and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis

  • End date
    Dec 14, 2024
  • participants needed
  • sponsor
    Caelum Biosciences, Inc.
Updated on 9 April 2022
platelet count
renal function
direct bilirubin
blood disorder
monoclonal antibody
bone marrow procedure
glomerular filtration rate
neutrophil count
monoclonal protein
serum protein
cardiac amyloidosis
amyloid deposits
amyloid deposition
amyloid fibrils
abnormal proteins
mass spectrometry
abnormal protein
plasma cell dyscrasia


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 and it is safe and well tolerated in patients with stage IIIb AL amyloidosis.


This is a double-blind, randomized, multicenter international Phase 3 study of CAEL-101 combined with the standard of care (SoC) for plasma cell dyscrasia (PCD) versus placebo combined with standard of care PCD treatment in patients with Mayo stage IIIb AL amyloidosis that have not received prior treatment. The minimum planned treatment time for each patient will be at least 50 weeks or until the patient's death. It is planned that all patients will continue their double-blind treatment until the last patient completes at least 50 weeks of treatment.

Approximately 111 patients will be enrolled using a 2:1 randomization ratio of CAEL-101: placebo and will involve approximately 100 investigator sites.

The primary objective of this study is to assess the effects of CAEL-101 versus placebo on all-cause mortality.

Condition AL Amyloidosis
Treatment Placebo, CAEL-101, cyclophosphamide, bortezomib, and dexamethasone (CyBorD), cyclophosphamide, bortezomib, and dexamethasone (CyBorD) regimen
Clinical Study IdentifierNCT04504825
SponsorCaelum Biosciences, Inc.
Last Modified on9 April 2022


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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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