Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial
Official title:
The Clinical and Biologic Evaluation of Polyphenon E, an Extract of Green Tea Containing EGCG, in Plasma Cell Dyscrasias - Pilot Study
RATIONALE: Green tea extract contains ingredients that may prevent or slow the growth of
monoclonal gammopathy of undetermined significance and/or smoldering multiple myeloma.
PURPOSE: This phase II trial is studying how well green tea extract works in treating
patients with monoclonal gammopathy of undetermined significance and/or smoldering multiple
myeloma.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
unacceptable toxicity.
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
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