Cardiac Involvement, Light Chain (AL) Amyloidosis
Conditions
Keywords
Amyloidosis
Brief 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.
Interventions
Pharmaceutical formulation: capsules Dose: 400 mg/d for 3 months; 800 mg/d for 3 months, 1200 mg/d for 6 months Route of administration: p.o. Treatment duration: 12 months
DRUGPlacebo
Pharmaceutical formulation: capsules Dose: 400 mg/d for 3 months; 800 mg/d for 3 months, 1200 mg/d for 6 months Route of administration: p.o. Treatment duration: 12 months
Sponsors
German Federal Ministry of Education and Research
Florian Michel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| compare the 12 month change in left ventricular mass | 12 month | The primary analysis to compare the 12 month change in left ventricular mass between the two treatment arms will be performed by a one-sided two-sample t test at a significance level of 0.025. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety of EGCG | 12 month | Number of adverse events according to CTC criteria (Version 4.0) |
| change in cardiac biomarkers | Baseline, 12 Month | cardiac troponin T (hsTNT), NTproBNP |
| Change in Quality of Life | baseline, 12 month | Quality of Life, evaluated with EORTC-QLQ-C30 |
| Organ response in affected organs other than heart | Baseline, 12 Month | Organ response according to Gertz et al 2005 |
| Overall Survival | 12 Month | — |
| improvement of hematological remission | Baseline, 12 Month | Hematological Response according to Palladini et al 2012 |
Countries
Germany
Outcome results
None listed