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CAEL-101 for Amyloidosis
Study Summary
This trial is testing a new treatment for AL amyloidosis, which is a disease where abnormal proteins misfold and create free light chains that build up in organs. The new treatment, CAEL-101, is a monoclonal antibody that removes AL amyloid deposits from tissues and organs. The trial will test whether CAEL-101 improves overall survival and is safe and well tolerated in patients with stage IIIb AL amyloidosis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have a type of amyloidosis that is not AL amyloidosis.My blood pressure is very low or drops significantly when I stand up, despite treatment.I have POEMS syndrome or multiple myeloma with specific symptoms or test results.I have heart issues due to AL amyloidosis, confirmed by tests.My diagnosis of amyloidosis was confirmed through specific tests on tissue samples.I am a man who is either surgically sterile or will use effective birth control and not donate sperm during and up to 5 or 12 months after the study, depending on my treatment.My first treatment for my blood disorder will be with CyBorD.You have specific levels of abnormal proteins in your blood that can be measured.My AL amyloidosis is classified as stage IIIb.I have been treated for AL amyloidosis or multiple myeloma, but only had a short treatment after my screening.
- Group 1: CAEL-101 combined with SoC plasma cell dyscrasia
- Group 2: Placebo combined with SoC plasma cell dyscrasia
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many people are participating in this clinical trial?
"The information available on clinicaltrials.gov does verify that this study is still looking for patients to participate. This trial was first posted on February 2nd, 2021 and last updated November 4th, 2022. A total of 124 people are being accepted at 62 different hospitals or clinics."
In how many different hospitals is this trial taking place?
"There are 62 active sites for this study, some of which include Houston Methodist Hospital in Chapel Hill, North carolina; The Ohio State University in Seattle, Washington; and Mayo Clinic - Rochester in Dallas, Texas."
Are patients being actively sought for this experiment?
"The most recent information from clinicaltrials.gov suggests that this particular trial is still recruiting patients. The listing for the trial was created on February 2nd, 2021 and edited November 4th, 2022."
Are there other precedent clinical trials that have used CAEL-101?
"There are a total of 1,361 studies investigating CAEL-101. Of these live studies, 278 are in Phase 3 clinical trials. The largest concentration of research is based in Philadelphia, however there are 42,626 locations globally running trials for this treatment."
Has CAEL-101 gained approval from the Federal Drug Administration?
"CAEL-101 has undergone Phase 3 trials, so there is available evidence of both its efficacy and safety. Our team at Power rated CAEL-101's safety as a 3."
What is the primary purpose of CAEL-101?
"CAEL-101 is used to manage synovitis and can also help patients suffering from ophthalmia, sympathetic, and branch retinal vein occlusion, as well as certain types of lung cancer."
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