The Clinical and Biologic Evaluation of Polyphenon E, an Extract of Green Tea Containing EGCG, in Plasma Cell Dyscrasias - Pilot Study
- Conduct a pilot study investigating the effects of Polyphenon E, a compound extracted
from green tea which contains epigallocatechin-3-gallate (EGCG), on monoclonal protein
levels in patients with monoclonal gammopathy of undetermined significance and/or
smoldering multiple myeloma.
- Collect, process, and store blood and marrow specimens for future measurement of the
biologic effects of Polyphenon E on the plasma cells of these patients by utilizing
proteosome activity assays and gene expression profiling.
OUTLINE: 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
Patients may undergo blood, urine, and bone marrow sample collection periodically for
correlative laboratory studies. Samples are analyzed for monoclonal protein (M-protein)
levels, proteosome function, and gene expression.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Sustained M-protein reduction of ≥ 25% from baseline
Day one of each cycle
Jeffrey A. Zonder, MD
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|