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

Study Identifier:
CAEL101-301
ClinicalTrials.gov Identifier:
NCT04504825
EudraCT Identifier:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
1-855-752-2356 or [email protected]
Recruitment Complete

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: CAEL-101
  • Drug: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimen
Date
Feb 2021 - May 2025
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 Years - n/a
Requirements Information
Sex
Female & Male
Age
18 Years - n/a

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: CAEL-101
  • Drug: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimen
Date
Feb 2021 - May 2025
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 Years - n/a years
Requirements Information

Protocol 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.

Trial Locations

Location
Status
Location
Research Site
Wirral, United Kingdom, CH63 4JY
Status
Withdrawn
Location
Research Site
Recife, Unmapped, 50040-000
Status
Withdrawn
Location
Research Site
Seoul, Unmapped, 06351
Status
Active, not recruiting
Location
Research Site
Muenster, Unmapped, 48149
Status
Withdrawn
Location
Research Site
Ribeirão Preto, Unmapped, 14048-900
Status
Active, not recruiting
Location
Research Site
Ostrava - Poruba, Czech Republic, 70852
Status
Active, not recruiting