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

Phase 2

Completed

• Conditions: Amyloidosis; Amyloid light-chain amyloidosis; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN68399350
• Lead Sponsor: Ruprecht-Karls-University of Heidelberg (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-05
• Last Update Posted: 19 December 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 38

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

Exclusion Criteria

1. Age < 18 years
2. Concomitant multiple myeloma stage II and III (Salmon and Durie)
3. Concurrent chemotherapy necessary
4. Time to last chemotherapy > 6 months
5. Chronic liver disease
6. Bilirubin > 1,5 mg/dl
7. Not able to visit Amyloidosis Clinic in Heidelberg every 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eft ventricular mass, measured by cardiac MRI

Secondary Outcome Measures

Name	Time	Method
1. Quality of life, measured using the EORTC-QLQ-C30<br>2. Left ventricle (LV) end diastolic and end systolic volumes with resulting ejection fraction, measured by cardiac MRI<br>3. Cardiac function parameters (calculated left ventricular mass, Tissue DI, TAPSE, MAPSE)<br>4. Cardiac biomarkers (cardiac troponin T hsTNT, NTproBNP)<br>5. 6-minute walk distance<br>6. Organ response in other affected organs, Gertz et al., 2005; standard criteria<br>7. Improvement of hematological remission<br>8. Overall survival<br>9. Correlation of epigallocatechin gallate (EGCG) serum levels with organ response<br>10. Number of adverse events according to Common Toxicity Criteria (CTC) version 4.0<br>Measured 12 months after the start of treatment