A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-… (NCT02015312) | Clinical Trial Compass
CompletedPhase 2
A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)
Germany38 participantsStarted 2013-04
Plain-language summary
Efficacy and safety of epigallocatechin-3-gallate (EGCG) in patients with cardiac amyloid light-chain (AL) amyloidosis. Evaluation of clinical efficacy of EGCG intake using a pretest posttest comparison of left ventricular amyloid mass (g/m2) measured by cardiac MRI.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Biopsy proven systemic AL amyloidosis.
* Cardiac involvement with septum thickness more than 12 mm (without other causes as published by Gertz et al., hypertension or other potential causes of left ventricular hypertrophy)
* Previously treated with chemotherapy, induced at least a very good partial remission of the underlying monoclonal plasma cell or B cell disorder.
* GPT and GOT less than 3-times ULN.
* Life expectancy more than 12 month.
* Ability of subject to understand character and individual consequences of the clinical trail.
* Written informed consent.
* For women with childbearing potential and men, adequate contraception.
Exclusion Criteria:
* Age less than 18 years.
* Concomitant multiple myeloma stage 2 and 3 (Salmon and Durie)
* Concurrent chemotherapy necessary
* Time to last chemotherapy more than 6 months.
* Chronic liver disease, Bilirubin over 1,5 mg/dl
* Not able to visit Amyloidosis Clinic in Heidelberg every 3 months.
* History of hypersensitivity to the investigational product or to any substance with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
* Participation in other clinical trials or observation period of competing trials, respectively.
* Pregnant or nursing women.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
compare the 12 month change in left ventricular mass