Monoclonal Antibodies
CAEL-101 for AL Amyloidosis
Cleveland Clinic Amyloidosis Center, Cleveland, OH
CAEL-101 +2 morePhase 3RecruitingResearch Sponsored by AlexionEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- At least one of the following:
Cardiac involvement as defined by:
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up50 weeks
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Approved for 60 Other Conditions
Study Summary
This trial is testing a drug to see if it can improve overall survival for people with stage IIIa AL amyloidosis, a disease where abnormal proteins build up in organs.
Eligible Conditions
- AL Amyloidosis
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You must have at least one of the following:
Select...
You have a heart condition that may affect your ability to participate in the study.
Select...
You have signs and symptoms of heart failure along with a confirmed diagnosis of AL amyloidosis, and there is no other reason for your heart failure.
Select...
The planned initial treatment for your plasma cell disorder involves a combination of medications called cyclophosphamide, bortezomib, and dexamethasone, which is the standard of care.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 50 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~50 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with treatment emergent adverse events as assessed by CTCAE v5.0
Time from the date of randomization to date of death or end of study
Secondary outcome measures
Cardiac Improvement by Global Longitudinal Strain (GLS%)
Change in distance walked (in meters) during a six-minute walk test
Quality of Life (QOL) by the Kansas City Cardiomyopathy Questionnaire-Overall Score (KCCQ-OS)
+1 moreOther outcome measures
24-hour Urine Protein Measure
Assessment of limitation during physical activity
Changes in Amyloid Load of the Heart, Liver and Spleen
+13 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CAEL-101 combined with SoC plasma cell dyscrasiaExperimental Treatment2 Interventions
CAEL-101 is administered as an intravenous (IV) infusion over approximately 2 hours. 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. As this is an event driven study, the study will continue, and all patients will continue to receive study treatment until at least 79 deaths have been observed.
Group II: Placebo combined with SoC plasma cell dyscrasiaPlacebo Group2 Interventions
Patients randomized to receive placebo will receive 0.9% normal saline in an equivalent volume to a CAEL-101 infusion (approximately 250 cc). 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. As this is an event driven study, the study will continue, and all patients will continue to receive study treatment until at least 79 deaths have been observed.
Find a site
Who is running the clinical trial?
AlexionLead Sponsor
241 Previous Clinical Trials
39,124 Total Patients Enrolled
2 Trials studying AL Amyloidosis
149 Patients Enrolled for AL Amyloidosis
AstraZenecaIndustry Sponsor
4,118 Previous Clinical Trials
336,391,938 Total Patients Enrolled
1 Trials studying AL Amyloidosis
124 Patients Enrolled for AL Amyloidosis
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,512 Total Patients Enrolled
2 Trials studying AL Amyloidosis
149 Patients Enrolled for AL Amyloidosis
Caelum BiosciencesLead Sponsor
2 Previous Clinical Trials
149 Total Patients Enrolled
2 Trials studying AL Amyloidosis
149 Patients Enrolled for AL Amyloidosis
Caelum Biosciences, Inc.Lead Sponsor
2 Previous Clinical Trials
149 Total Patients Enrolled
2 Trials studying AL Amyloidosis
149 Patients Enrolled for AL Amyloidosis
Masood Sadaat, MD, MSc, ACRP-CPStudy Director
Alexion, AstraZeneca Rare DiseaseCristina C Quarta, MD, PhDStudy Director
Alexion, AstraZeneca Rare Disease1 Previous Clinical Trials
124 Total Patients Enrolled
1 Trials studying AL Amyloidosis
124 Patients Enrolled for AL Amyloidosis
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there other similar testing procedures for CAEL-101?
"Right now, there are over 1300 trials researching CAEL-101 with almost 300 of those in Phase 3. Most of the testing for CAEL-101 is happening in Philadelphia, but there are 43000+ locations running studies related to CAEL-101."
Answered by AI
Does this trial have a lot of locations in North America?
"67 medical centres across the United States are participating in this clinical trial, including renowned institutions such as Indiana University School of Medicine Amyloid Research and Treatment, Medical College of Wisconsin, and Memorial Sloan Kettering Cancer Center."
Answered by AI
What are the conditions that CAEL-101 is designed to address?
"Oftentimes, CAEL-101 is used to ameliorate synovitis. Additionally, it has shown efficacy in treating ophthalmia, cancerous growths in the lungs, and branch retinal vein occlusion."
Answered by AI
Has CAEL-101 received permission from the FDA to be used?
"CAEL-101 is safe according to our team's estimation. This is a Phase 3 trial, which means that efficacy has been supported by some data and safety has multiple rounds of supportive data."
Answered by AI
Who else is applying?
What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine
Clinical Trial Site
What portion of applicants met pre-screening criteria?
Met criteria