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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02015312
• Date of registration: 18/11/2013
• Prospective Registration: No
• Primary sponsor: Florian Michel
• Public title: A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL) TAME-AL
• Scientific title: A Randomised Trial for the Treatment of Cardiac AMyloid Light-chain Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)
• Date of first enrolment: April 2013
• Target sample size: 38
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02015312
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Germany

Contacts

• Name: Stefan Schönland, MD
• Affiliation: University Hospital of Heidelberg

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Light Chain (AL) Amyloidosis

Cardiac Involvement

Intervention(s)

Drug: Placebo

Drug: Epigallocatechin-3-gallate (EGCG)

Primary Outcome(s)

compare the 12 month change in left ventricular mass [Time Frame: 12 month]

Secondary Outcome(s)

Change in Quality of Life [Time Frame: baseline, 12 month]

improvement of hematological remission [Time Frame: Baseline, 12 Month]

Overall Survival [Time Frame: 12 Month]

safety of EGCG [Time Frame: 12 month]

change in cardiac biomarkers [Time Frame: Baseline, 12 Month]

Organ response in affected organs other than heart [Time Frame: Baseline, 12 Month]

Secondary ID(s)

TAME-AL

2012-004520-38

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

German Federal Ministry of Education and Research