NCT00942422

Green Tea Extract in Treating Patients With Monoclonal Gammopathy of Undetermined Significance and/or Smoldering Multiple Myeloma

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm
• Precancerous Condition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	defined green tea catechin extract	Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)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.
GENETIC	gene expression analysis	Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the first cycle of therapy.
GENETIC	protein analysis	Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the first cycle of therapy.
OTHER	laboratory biomarker analysis	Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the first cycle of therapy.

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2009-07-20
• Last updated: 2015-03-27
• Results posted: 2015-03-27

Locations

1 site across 1 country: United States