Summary:
If you have been recently diagnosed with AL (light chain) amyloidosis, you may be able to take part in a clinical research study.
The purpose of the CARES Studies is to evaluate the effectiveness and safety of an investigational medication paired with plasma cell dyscrasia (PCD) therapy (compared to a placebo paired with PCD therapy) in adults ages 18 years or older with AL amyloidosis who have never had PCD therapy. The CARES Studies are evaluating if the investigational medication (CAEL-101) may improve overall survival rate in participants with stage IIIa and IIIb AL amyloidosis. The investigational medication will be administered as an intravenous (IV) infusion.
All participants who qualify will receive the investigational medication or a placebo, plus PCD therapy, as well as study-related exams and study-related laboratory tests at no cost. Compensation for time and travel may also be available.
Eligible participants must:
- Be at least 18 years of age
- Have a diagnosis of Mayo stage IIIa or IIIb AL amyloidosis
- Not be pregnant or breastfeeding
- Not have any other form of amyloidosis other than AL amyloidosis
- Not have received prior therapy for AL amyloidosis or multiple myeloma
Other protocol-defined inclusion and exclusion criteria may apply.