A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)

A Randomised Trial for the Treatment of Cardiac AMyloid Light-chain Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)

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.

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.