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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00942422 |
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Date of registration:
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17/07/2009 |
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Primary sponsor: |
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Public title:
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Green Tea Extract in Treating Patients With Monoclonal Gammopathy of Undetermined Significance and/or Smoldering Multiple Myeloma
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Scientific title:
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The Clinical and Biologic Evaluation of Polyphenon E, an Extract of Green Tea Containing EGCG, in Plasma Cell Dyscrasias - Pilot Study |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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8 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00942422 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Jeffrey A. Zonder, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Barbara Ann Karmanos Cancer Institute |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Diagnosis of monoclonal gammopathy of undetermined significance (MGUS) and/or
smoldering multiple myeloma (SMM)
- Measurable monoclonal protein in the serum (= 1.0 g/dL) and/or urine (= 500
mg/24 hrs)
- No confirmed symptomatic multiple myeloma, defined by any of the following:
- Lytic lesions on skeletal survey
- Anemia attributable to plasma cell infiltrate in marrow
- Hypercalcemia
- Renal dysfunction not attributable to other causes
PATIENT CHARACTERISTICS:
- Life expectancy = 6 months
- ANC = 1,500/mm^3
- Platelet count = 100,000/mm^3
- Hemoglobin = 9 mg/dL
- ALT and AST normal
- Total bilirubin normal
- Alkaline phosphatase normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 30 days after
completion of study treatment
- Willing to comply with oral home treatment and visit schedule
- No concurrent uncontrolled illness including, but not limited to, any of the
following:
- Active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would compromise compliance with
study medication or follow-up visits
- No chronic liver disease (e.g., hepatitis B, hepatitis C, or alcoholic cirrhosis)
- No high predisposition to gastrointestinal bleeding (e.g., known gastroesophageal
varices or active peptic ulcer disease)
- No adverse symptoms related to green tea or any of the inactive components present in
Polyphenon E capsules
PRIOR CONCURRENT THERAPY:
- More than 6 months since prior daily ingestion of green tea or green tea extract
- At least 4 weeks since prior therapy
- No other concurrent investigational or commercial agents or therapies with the intent
to treat MGUS and/or SMM
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Myeloma and Plasma Cell Neoplasm
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Precancerous Condition
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Intervention(s)
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Dietary Supplement: defined green tea catechin extract
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Genetic: gene expression analysis
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Genetic: protein analysis
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Other: laboratory biomarker analysis
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Primary Outcome(s)
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Sustained M-protein reduction of = 25% from baseline
[Time Frame: Day one of each cycle]
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Secondary ID(s)
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CDR0000646899
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P30CA022453
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WSU-2009-015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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