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

  • STATUS
    Recruiting
  • End date
    Dec 14, 2024
  • participants needed
    111
  • sponsor
    Caelum Biosciences, Inc.
Updated on 9 April 2022
platelet count
renal function
hypertension
cyclophosphamide
direct bilirubin
blood disorder
monoclonal antibody
MRI
bone marrow procedure
glomerular filtration rate
dexamethasone
neutrophil count
immunohistochemistry
bortezomib
monoclonal protein
immunoglobulin
serum protein
cardiac amyloidosis
amyloid deposits
electrophoresis
amyloid deposition
amyloid fibrils
abnormal proteins
nervous
mass spectrometry
abnormal protein
plasma cell dyscrasia
cael-101

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

Description

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.

Details
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

Eligibility

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note