Trial Outcomes & Findings for Green Tea Extract in Treating Patients With Monoclonal Gammopathy of Undetermined Significance and/or Smoldering Multiple Myeloma (NCT NCT00942422)
NCT ID: NCT00942422
Last Updated: 2015-03-27
Results Overview
This is a monthly blood test, done at the beginning of each cycle of therapy. The M-protein is a surrogate marker routinely used to estimate the degree of plasma cell cyto-reduction brought about by therapy. In active multiple myeloma, a 25% reduction in the M-protein level would correspond to a "minor response," an improvement recognized as having some clinical benefit.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Day one of each 28-day cycle for a total of up to 6 cycles
Results posted on
2015-03-27
Participant Flow
Participant milestones
| Measure |
Defined Green Tea Catechin Extract / Correlative Analysis
Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Overall Study
STARTED
|
8
|
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Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Defined Green Tea Catechin Extract / Correlative Analysis
Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Progressive diease
|
1
|
Baseline Characteristics
Green Tea Extract in Treating Patients With Monoclonal Gammopathy of Undetermined Significance and/or Smoldering Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Defined Green Tea Catechin Extract / Correlative Analysis
n=8 Participants
Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal). Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day one of each 28-day cycle for a total of up to 6 cyclesThis is a monthly blood test, done at the beginning of each cycle of therapy. The M-protein is a surrogate marker routinely used to estimate the degree of plasma cell cyto-reduction brought about by therapy. In active multiple myeloma, a 25% reduction in the M-protein level would correspond to a "minor response," an improvement recognized as having some clinical benefit.
Outcome measures
| Measure |
Defined Green Tea Catechin Extract / Correlative Analysis
n=8 Participants
Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
defined green tea catechin extract: Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
gene expression analysis: Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the
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|---|---|
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Sustained M-protein Reduction of ≥ 25% From Baseline
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0 percentage of patients
|
Adverse Events
Defined Green Tea Catechin Extract / Correlative Analysis
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Defined Green Tea Catechin Extract / Correlative Analysis
n=8 participants at risk
Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
gene expression analysis: Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the
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|---|---|
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Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
1/8
|
Other adverse events
| Measure |
Defined Green Tea Catechin Extract / Correlative Analysis
n=8 participants at risk
Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
gene expression analysis: Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the
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|---|---|
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Blood and lymphatic system disorders
Neutropenia
|
37.5%
3/8 • Number of events 3
|
|
Blood and lymphatic system disorders
Leukopenia
|
37.5%
3/8 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphopenia
|
50.0%
4/8 • Number of events 4
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
50.0%
4/8 • Number of events 4
|
|
Gastrointestinal disorders
Reflux
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Loose Stools
|
37.5%
3/8 • Number of events 3
|
|
Gastrointestinal disorders
Difficulty Swallowing Pills
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Bloating
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Increased ALT
|
25.0%
2/8 • Number of events 2
|
|
Metabolism and nutrition disorders
Increased AST
|
37.5%
3/8 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
8/8 • Number of events 8
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
50.0%
4/8 • Number of events 4
|
|
Metabolism and nutrition disorders
Increased Creatinine
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
25.0%
2/8 • Number of events 2
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Palpable left axillary and mandibular lymph nodes
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Brusing left arm
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Shingles
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Jock Itch
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
2/8 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Viral Respiratory Infection
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Post Nasal Drip
|
12.5%
1/8 • Number of events 1
|
|
Cardiac disorders
Heart Palpitation
|
12.5%
1/8 • Number of events 1
|
|
Cardiac disorders
Borderline bradycardia
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Fatigue
|
25.0%
2/8 • Number of events 2
|
|
General disorders
Insomnia
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Night sweats
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Weight Gain
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Belching
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Skin Redness
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Mood Changes
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Ankle Tenderness/Pain
|
25.0%
2/8 • Number of events 2
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 2
|
|
General disorders
Back Pain
|
25.0%
2/8 • Number of events 2
|
|
General disorders
Chest Pain
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Cramping in neck
|
12.5%
1/8 • Number of events 1
|
Additional Information
Jeffrey Zonder, M.D.
Barbara Ann Karmanos Cancer Institute
Phone: 313-576-8732
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place