What is the PO authorization in ECGC

A study of the treatment of cardiac AL amyloidosis with the green tea compound epigallocatechin-3-gallate (TAME-AL)

Inclusion criteria:

- Systemic AL amyloidosis demonstrated by biopsy.

- Heart involvement with a septum thickness greater than 12 mm (excluding causes other than those published by Gertz et al., Hypertension or other possible 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 months.

- Ability of the subject to understand the character and individual consequences of the clinic way.

- Written declaration of consent.

- Appropriate contraception for women of childbearing potential and men.

Exclusion criteria:

- Age under 18 years.

- Concomitant multiple myeloma stage 2 and 3 (salmon and durie)

- Simultaneous chemotherapy required

- Time to the last chemotherapy longer than 6 months.

- Chronic liver disease, bilirubin above 1.5 mg / dL

- The amyloidosis clinic in Heidelberg cannot be visited every 3 months.

- Hypersensitivity to the investigational medicinal product or a substance with a similar chemical structure or to one in the pharmaceutical form of the investigational medicinal product.

- Participation in other clinical studies or observation period of competing studies, respectively.

- Pregnant or breastfeeding women.