Clinical trial NCT00942422: Green Tea Extract in Treating Patients With Monoclonal Gammopathy of Undetermined Significance and/or Smoldering Multiple Myeloma
Official title: The Clinical and Biologic Evaluation of Polyphenon E, an Extract of Green Tea Containing EGCG, in Plasma Cell Dyscrasias - Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Precancerous Condition
Keywords: monoclonal gammopathy of undetermined significance
smoldering multiple myeloma
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-07-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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 cirrhosis)
* Prior daily ingestion of green tea or green tea extract within 6 months of study entry
* 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

Primary outcomes:
measure: Sustained M-protein Reduction of ≥ 25% From Baseline
timeFrame: Day one of each 28-day cycle for a total of up to 6 cycles
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Jeffrey A. Zonder, MD
role: PRINCIPAL_INVESTIGATOR
References: