The Clinical and Biologic Evaluation of Polyphenon E, an Extract of Green Tea Containing EGCG, in Plasma Cell Dyscrasias - Pilot Study

Inclusion Criteria

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