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

Light Chain (AL) Amyloidosis Clinical Trial

— TAME-AL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02015312
• Other study ID #: TAME-AL
• Secondary ID: 2012-004520-38
• Status: Completed
• Phase: Phase 2
• First received: November 18, 2013
• Last updated: October 16, 2017
• Start date: April 2013
• Est. completion date: October 11, 2017

Study information

• Verified date: October 2017
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 11, 2017
• Est. primary completion date: October 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyloidosis
• Cardiac Involvement
• Light Chain (AL) Amyloidosis

Intervention

Drug:
• Epigallocatechin-3-gallate (EGCG)
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
• Placebo
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

Locations

Country	Name	City	State
Germany	University Hospital of Heidelberg; Medical Department V	Heidelberg	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Florian Michel	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare the 12 month change in left ventricular mass	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.	12 month
Secondary	Change in Quality of Life	Quality of Life, evaluated with EORTC-QLQ-C30	baseline, 12 month
Secondary	safety of EGCG	Number of adverse events according to CTC criteria (Version 4.0)	12 month
Secondary	change in cardiac biomarkers	cardiac troponin T (hsTNT), NTproBNP	Baseline, 12 Month
Secondary	improvement of hematological remission	Hematological Response according to Palladini et al 2012	Baseline, 12 Month
Secondary	Organ response in affected organs other than heart	Organ response according to Gertz et al 2005	Baseline, 12 Month
Secondary	Overall Survival		12 Month