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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Sustained M-protein reduction of at least 25%
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.
Baseline, day 8 of course 1, and day 1 of each subsequent course
Barbara Ann Karmanos Cancer Institute
United States: Food and Drug Administration
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|