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

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ClinicalTrials.gov Identifier: NCT00942422
Recruitment Status : Terminated (Low accrual and early termination)
First Posted : July 20, 2009
Results First Posted : March 27, 2015
Last Update Posted : March 27, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jeffrey Zonder, Barbara Ann Karmanos Cancer Institute

Study Description
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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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Precancerous Condition Dietary Supplement: defined green tea catechin extract Genetic: gene expression analysis Genetic: protein analysis Other: laboratory biomarker analysis Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical and Biologic Evaluation of Polyphenon E, an Extract of Green Tea Containing EGCG, in Plasma Cell Dyscrasias - Pilot Study
Study Start Date : November 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: defined green tea catechin extract / correlative analysis
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Sustained M-protein Reduction of ≥ 25% From Baseline [ Time Frame: Day one of each 28-day cycle for a total of up to 6 cycles ]
    This is a monthly blood test, done at the beginning of each cycle of therapy. The M-protein is a surrogate marker routinely used to estimate the degree of plasma cell cyto-reduction brought about by therapy. In active multiple myeloma, a 25% reduction in the M-protein level would correspond to a "minor response," an improvement recognized as having some clinical benefit.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942422


Locations
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United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jeffrey A. Zonder, MD Barbara Ann Karmanos Cancer Institute
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Jeffrey Zonder, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00942422    
Obsolete Identifiers: NCT01589887
Other Study ID Numbers: CDR0000646899
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2009-015 ( Other Identifier: Barbara Ann Karmanos Cancer Institute )
First Posted: July 20, 2009    Key Record Dates
Results First Posted: March 27, 2015
Last Update Posted: March 27, 2015
Last Verified: March 2015
Keywords provided by Jeffrey Zonder, Barbara Ann Karmanos Cancer Institute:
monoclonal gammopathy of undetermined significance
smoldering multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Precancerous Conditions
Smoldering Multiple Myeloma
Monoclonal Gammopathy of Undetermined Significance
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
 Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Hypergammaglobulinemia
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents