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

Primary Purpose

Light Chain (AL) Amyloidosis, Cardiac Involvement

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Epigallocatechin-3-gallate (EGCG)
Placebo
Sponsored by
Florian Michel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Light Chain (AL) Amyloidosis focused on measuring Amyloidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital of Heidelberg; Medical Department V

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Epigallocatechin-3-gallate (EGCG)

Placebo

Arm Description

EGCG 400 mg/d p.o. for 3 months; 800 mg/d p.o. for 3 months, 1200 mg/d p.o. for 6 months

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Quality of Life
Quality of Life, evaluated with EORTC-QLQ-C30
safety of EGCG
Number of adverse events according to CTC criteria (Version 4.0)
change in cardiac biomarkers
cardiac troponin T (hsTNT), NTproBNP
improvement of hematological remission
Hematological Response according to Palladini et al 2012
Organ response in affected organs other than heart
Organ response according to Gertz et al 2005
Overall Survival

Full Information

First Posted
November 18, 2013
Last Updated
October 16, 2017
Sponsor
Florian Michel
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT02015312
Brief Title
A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 11, 2017 (Actual)
Study Completion Date
October 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Florian Michel
Collaborators
German Federal Ministry of Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Light Chain (AL) Amyloidosis, Cardiac Involvement
Keywords
Amyloidosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epigallocatechin-3-gallate (EGCG)
Arm Type
Experimental
Arm Description
EGCG 400 mg/d p.o. for 3 months; 800 mg/d p.o. for 3 months, 1200 mg/d p.o. for 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Epigallocatechin-3-gallate (EGCG)
Other Intervention Name(s)
Epigallocatechin gallate, EGCG, Epigallocatechin 3-gallate, Tea catechin, Epigallocatechin-3-gallate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Mannitol 99.5% + highly dispersed silicon dioxide 0.5%
Intervention Description
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
Primary Outcome Measure Information:
Title
compare the 12 month change in left ventricular mass
Description
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.
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Change in Quality of Life
Description
Quality of Life, evaluated with EORTC-QLQ-C30
Time Frame
baseline, 12 month
Title
safety of EGCG
Description
Number of adverse events according to CTC criteria (Version 4.0)
Time Frame
12 month
Title
change in cardiac biomarkers
Description
cardiac troponin T (hsTNT), NTproBNP
Time Frame
Baseline, 12 Month
Title
improvement of hematological remission
Description
Hematological Response according to Palladini et al 2012
Time Frame
Baseline, 12 Month
Title
Organ response in affected organs other than heart
Description
Organ response according to Gertz et al 2005
Time Frame
Baseline, 12 Month
Title
Overall Survival
Time Frame
12 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Schönland, MD
Organizational Affiliation
University Hospital of Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Heidelberg; Medical Department V
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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