Treatment of cardiac amyloid light-chain amyloidosis with the green tea compound epigallocatechin-3-galiate

INTERVENTION: EGCG capsules 400‐1200 mg in increasing dosages or placebo for 1 year CONDITION: Amyloid light‐chain amyloidosis ; Nutritional, Metabolic, Endocrine ; Amyloidosis PRIMARY OUTCOME: Left ventricular mass, measured by cardiac MRI SECONDARY OUTCOME: 1. Quality of life, measured using the EORTC‐QLQ‐C30; 2. Left ventricle (LV) end diastolic and end systolic volumes with resulting ejection fraction, measured by cardiac MRI; 3. Cardiac function parameters (calculated left ventricular mass, Tissue DI, TAPSE, MAPSE); 4. Cardiac biomarkers (cardiac troponin T hsTNT, NTproBNP); 5. 6‐minute walk distance; 6. Organ response in other affected organs, Gertz et al., 2005; standard criteria; 7. Improvement of hematological remission; 8. Overall survival; 9. Correlation of epigallocatechin gallate (EGCG) serum levels with organ response; 10. Number of adverse events according to Common Toxicity Criteria (CTC) version 4.0; Measured 12 months after the start of treatment INCLUSION CRITERIA: 1. Biopsy proven systemic AL amyloidosis 2. Cardiac involvement with septum thickness >12 mm (without other causes as published by Gertz et al) 3. Hypertension or other potential causes of left ventricular hypertrophy 4. Previously treated with chemotherapy 5. Induced at least a very good partial remission of the underlying monoclonal plasma cell or B cell disorder