Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/09/2012
Date assigned
05/10/2012
Last edited
30/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Systemic amyloid light-chain amyloidosis is a rare but serious condition where abnormal bone marrow cells produce excessive amounts of abnormal proteins, which form deposits called amyloid in tissues and organs throughout the body. Amyloid deposited in the heart can cause it to become enlarged and impair its ability to pump blood efficiently around the body, which may result in heart failure. Treatment currently involves having chemotherapy to damage the abnormal bone marrow cells and stop the production of the abnormal proteins. Epigallocatechin-3-gallate (EGCG), a chemical found in found in green tea, may be able to reduce the formation of amyloid and break it down. The aim of this study is to find out whether EGCG is able to reduce amyloid deposition in the heart.

Who can participate?
Patients with systemic amyloid light-chain amyloidosis affecting the heart

What does the study involve?
Participants are randomly allocated to take either increasing doses of EGCG capsules or a placebo (dummy drug) for 12 months. Participants come to the center for tests every 3 months. Echocardiography (a heart scan) is performed every 6 months. A heart MRI scan is carried out at the beginning and at the end of treatment.

What are the possible benefits and risks of participating?
EGCG may help to break down amyloid in the heart. There are no known risks of EGCG treatment.

Where is the study run from?
Ruprecht-Karls-University of Heidelberg (Germany)

When is the study starting and how long is it expected to run for?
December 2012 to November 2017

Who is funding the study?
Federal Ministry of Education and Research (Germany)

Who is the main contact?
Dr Stefan Schönland
stefan.schoenland@med.uni-heidelberg.de

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stefan Schönland

ORCID ID

Contact details

Medical Department V
(Hematology/Amyloidosis Clinic)
Im Neuenheimer Feld 672
Heidelberg
D-69120
Germany
-
stefan.schoenland@med.uni-heidelberg.de

Additional identifiers

EudraCT number

2012-004520-38

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised trial for the Treatment of cardiac AMyloid light-chain amyloidosis with the green tea compound Epigallocatechin-3-gALlate (TAME-AL)

Acronym

TAME-AL

Study hypothesis

One year treatment with Epigallocatechin-3-gallate (EGCG) reduces cardiac mass in patients with AL amyloidosis.

Ethics approval

Ethics Committee of The University Heidelberg, 08/04/2013, ref: AFmo-008/2013

Study design

Randomised placebo-controlled double-blind single-centre phase IIb study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Amyloid light-chain amyloidosis

Intervention

EGCG capsules 400-1200 mg in increasing dosages or placebo for 1 year

Intervention type

Drug

Phase

Phase II

Drug names

Epigallocatechin-3-gallate

Primary outcome measures

Left ventricular mass, measured by cardiac MRI

Secondary outcome measures

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

Overall trial start date

01/12/2012

Overall trial end date

10/11/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

38

Participant 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

Recruitment start date

01/12/2012

Recruitment end date

01/10/2016

Locations

Countries of recruitment

Germany

Trial participating centre

Medical Department V
Heidelberg
D-69120
Germany

Sponsor information

Organisation

Ruprecht-Karls-University of Heidelberg (Germany)

Sponsor details

Medical Faculty
represented by Universitätsklinikum Heidelberg
Im Neuenheimer Feld 672
Heidelberg
D-69120
Germany
-
irmtraud.guerkan@med.uni-heidelberg.de

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Bundesministerium für Bildung und Forschung FKZ: 01GM1107A

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

22/11/2016: Plain English summary added. 08/11/2016: The overall trial end date has been updated from 30/11/2015 to 10/11/2017.