A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis (CARES)
Study Identifier:
CAEL101-302
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
Recruitment Complete
Study Details
Medical Condition
- AL Amyloidosis
Study Drug
- Drug: CAEL-101
- Drug: cyclophosphamide, bortezomib, and dexamethasone (CyBorD) regimen
Date
Nov 2020 - Apr 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
- AL Amyloidosis
Study Drug
- Drug: CAEL-101
- Drug: cyclophosphamide, bortezomib, and dexamethasone (CyBorD) regimen
Date
Nov 2020 - Apr 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 IIIa AL amyloidosis.
Trial Locations
Location
Status
Location
Research Site
Pamplona, Unmapped, 31008
Status
Active, not recruiting
Location
Research Site
Tel Aviv, Unmapped, 64239
Status
Active, not recruiting
Location
Research Site
Adelaide, Unmapped, 5000
Status
Withdrawn
Location
Research Site
Salamanca, Unmapped, 37007
Status
Active, not recruiting
Location
Research Site
Linz, Unmapped, 4020
Status
Active, not recruiting
Location
Research Site
St. Petersburg, Russian Federation, 197022
Status
Active, not recruiting