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 measure
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 (if study stopped)
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
National government
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
Basic results (scientific)
Publication list