Green Tea Extract in Treating Patients With Monoclonal Gammopathy of Undetermined Significance and/or Smoldering Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm; Precancerous Condition
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Precancerous Conditions; Smoldering Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance
Intervention: defined green tea catechin extract; gene expression analysis; protein analysis; laboratory biomarker analysis
Intervention description: 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.; 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.; 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.; 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.
Intervention MeSH terms: Epigallocatechin gallate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: monoclonal gammopathy of undetermined significance; smoldering multiple myeloma

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.
    

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