Light Chain (AL) AmyloidosisPhase 2TAME-ALNCT02015312
A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)
A Phase 2 study testing Epigallocatechin-3-gallate (EGCG) in people with Light Chain (AL) Amyloidosis and Cardiac Involvement, run by Florian Michel at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Light Chain (AL) Amyloidosis, Cardiac Involvement
- What is being tested?
- Epigallocatechin-3-gallate (EGCG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to 11 Oct 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Heidelberg; Medical Department V
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: A Randomised Trial for the Treatment of Cardiac AMyloid Light-chain Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)
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.
- Conditions
- Light Chain (AL) Amyloidosis, Cardiac Involvement
- Being tested
- Epigallocatechin-3-gallate (EGCG), Placebo
- Keywords
- Amyloidosis
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epigallocatechin-3-gallate (EGCG)Drug
Also called Epigallocatechin gallate, EGCG, Epigallocatechin 3-gallate, Tea catechin
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
PlaceboDrug
Also called Mannitol 99.5% + highly dispersed silicon dioxide 0.5%
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
| Study group | Role | What they receive |
|---|---|---|
| Epigallocatechin-3-gallate (EGCG) | Experimental | 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 Receives: Drug: Epigallocatechin-3-gallate (EGCG) |
| Placebo | Placebo comparator | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 month
Secondary outcomes (6)
Change in Quality of Life
Quality of Life, evaluated with EORTC-QLQ-C30
Measured: baseline, 12 month
safety of EGCG
Number of adverse events according to CTC criteria (Version 4.0)
Measured: 12 month
change in cardiac biomarkers
cardiac troponin T (hsTNT), NTproBNP
Measured: Baseline, 12 Month
improvement of hematological remission
Hematological Response according to Palladini et al 2012
Measured: Baseline, 12 Month
Organ response in affected organs other than heart
Organ response according to Gertz et al 2005
Measured: Baseline, 12 Month
Overall Survival
Measured: 12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startApr 2013
- Primary completion11 Oct 2017
- Study completion11 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Light Chain (AL) AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florian Michel
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Sponsor-investigator, Florian Michel, University Hospital Heidelberg
- Investigators
- Stefan Schönland, MD, Principal investigator, University Hospital of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015312
- Sponsor's protocol ID
- TAME-AL
- Other IDs
- 2012-004520-38
- Acronym
- TAME-AL
- Status last verified
- Oct 2017
- First submitted
- 18 Nov 2013
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial for the Treatment of Cardiac AMyloid Light-chain Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)
- ClinicalTrials.gov ID
- NCT02015312
- Acronym / sponsor ID
- TAME-AL / TAME-AL
- Conditions
- Light Chain (AL) Amyloidosis, Cardiac Involvement
- Keywords
- Amyloidosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Florian MichelUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Apr 2013
- Primary completion
- 11 Oct 2017 (actual)
- Study completion
- 11 Oct 2017 (actual)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epigallocatechin-3-gallate (EGCG) | Experimental | Drug: Epigallocatechin-3-gallate (EGCG)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 |
| Placebo | Placebo comparator | Drug: Placebocapsules 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epigallocatechin-3-gallate (EGCG)Also: Epigallocatechin gallate, EGCG, Epigallocatechin 3-gallate, Tea catechinPharmaceutical 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 | Drug | Epigallocatechin-3-gallate (EGCG) |
| PlaceboAlso: Mannitol 99.5% + highly dispersed silicon dioxide 0.5%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 | Drug | Placebo |
Primary outcome
compare the 12 month change in left ventricular mass
Time frame: 12 month
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.
6 secondary outcomes
Change in Quality of Life
Time frame: baseline, 12 month
safety of EGCG
Time frame: 12 month
change in cardiac biomarkers
Time frame: Baseline, 12 Month
improvement of hematological remission
Time frame: Baseline, 12 Month
Organ response in affected organs other than heart
Time frame: Baseline, 12 Month
Overall Survival
Time frame: 12 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
Related trials for Light Chain (AL) Amyloidosis
RecruitingPhase 1
Study of GC012F, CAR-T Therapy Targeting CD19 and BCMA in Chinese Participants With Relapsed or Refractory AL Amyloidosis
Relapsed/Refractory AL Amyloidosis
Active, not recruitingPhase 2
Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis
Multiple Myeloma, AL Amyloidosis
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis
Amyloidosis
RecruitingPhase 1
A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis
Relapsed or Refractory Multiple Myeloma, Previously Treated Amyloid Light-chain (AL) Amyloidosis
Active, not recruitingPhase 2
A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
Amyloidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Schönland, MD principal investigator
University Hospital of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epigallocatechin-3-gallate (EGCG) in people with Light Chain (AL) Amyloidosis and Cardiac Involvement, run by Florian Michel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the 12 month change in left ventricular mass (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017.