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

Phase 2
18 Years
Open (Enrolling)
Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma

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Trial Information

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


I. Conduct a pilot study investigating the effects of Polyphenon E (defined green tea
catechin extract), a compound extracted from green tea, on monoclonal protein (M-protein)
levels in patients with monoclonal gammopathy of undetermined significance (MGUS) and/or
smoldering multiple myeloma (SMM).


I. Collect, process and store blood and marrow specimens for future measurement of the
biologic effects of Polyphenon E on the plasma cells of patients with MGUS and/or SMM
utilizing proteosome activity assays and gene expression profiling.


Patients receive defined green tea catechin extract orally (PO) once daily (QD) on days
1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.

Inclusion Criteria:

- Measurable monoclonal protein in the serum (for immunoglobin [Ig]G or IgM, >= 1.0
g/dL using serum protein electrophoresis [SPEP]/immunofixation electrophoresis [IFE];
for IgA, an SPEP/IFE confirming the presence of a monoclonal IgA band plus a
quantitative IgA level of >= 750 mg/dL) OR measurable urine Bence Jones paraprotein
(>= 500mg/24hrs) OR a measurable serum free light chain (FLC), defined as an involved
FLC level of >10 mg/dl, and a serum FLC ratio that is abnormal

- Neutrophil count >= 1,500

- Platelet count >= 100,000

- Hemoglobin >= 9mg/dL

- Alanine aminotransferase (ALT) =< institutional upper limit of normal (IULN)

- Aspartate aminotransferase (AST) =< IULN

- Total bilirubin =< IULN

- Alkaline phosphatase =< IULN

- Any ethnic group

- Prior therapy is allowed if >= 4 weeks prior to registration

- Life expectancy of at least 6 months

- Ability to understand and the willingness to sign a written informed consent document

- Willingness to comply with oral home treatment and visit schedule

- Patients with reproductive capacity must be willing to use adequate contraception
(barrier contraception, birth control pills, or other highly effective hormonal
agents) or abstain from sexual activity for the duration of the study and 30 days
beyond the end of therapy

Exclusion Criteria:

- Pregnant women

- Breastfeeding women

- Confirmed symptomatic multiple myeloma (MM), 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

- Uncontrolled intercurrent illness, including but not limited to active infection,
symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,
psychiatric illness or social situations that would compromise compliance with study
medication or follow up visits

- Patients with high predisposition to gastrointestinal bleeding, such as known
gastroesophageal varices or active peptic ulcer disease

- Patients with chronic liver disease (such as hepatitis B, hepatitis C, or alcoholic

- Prior daily ingestion of green tea or green tea extract within 6 months of study

- Patients who have previously experienced any adverse symptoms related to green tea or
any of the inactive components present in Polyphenon E capsules

- Concurrent use of investigational or commercial agent or therapy with the intent to
treat MGUS and/or SMM

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Sustained M-protein reduction of at least 25%

Outcome Description:

Defined as two successive measurements at least 28 days apart. Success will be estimated as binary proportion and 95% confidence intervals calculated using Wilson's method.

Outcome Time Frame:

Baseline, day 8 of course 1, and day 1 of each subsequent course

Safety Issue:


Principal Investigator

Jeffrey Zonder

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

November 2013

Related Keywords:

  • Monoclonal Gammopathy of Undetermined Significance
  • Smoldering Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Monoclonal Gammopathy of Undetermined Significance
  • Paraproteinemias



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201