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:
EudraCT Identifier:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
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
Requirements Information
Sex
Female & Male
Age
18+ years
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 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
Duarte, California, United States, 91010
Status
N/A
Location
Research Site
Palo Alto, California, United States, 94304
Status
N/A
Location
Research Site
San Francisco, California, United States, 94143
Status
N/A
Location
Research Site
Weston, Florida, United States, 33331
Status
N/A
Location
Research Site
Indianapolis, Indiana, United States, 46202
Status
N/A
Location
Research Site
New Orleans, Louisiana, United States, 70112
Status
N/A