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NCT00942422 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2015-03-27

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Sustained M-protein Reduction of ≥ 25% From Baseline

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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.
    intervention Names
    1. Dietary Supplement: defined green tea catechin extract
    2. Genetic: gene expression analysis
    3. Genetic: protein analysis
    4. Other: laboratory biomarker analysis
    label
    defined green tea catechin extract / correlative analysis
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. defined green tea catechin extract / correlative analysis
    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.
    name
    defined green tea catechin extract
    type
    DIETARY_SUPPLEMENT
  2. arm Group Labels
    1. defined green tea catechin extract / correlative analysis
    description
    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.
    name
    gene expression analysis
    type
    GENETIC
  3. arm Group Labels
    1. defined green tea catechin extract / correlative analysis
    description
    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.
    name
    protein analysis
    type
    GENETIC
  4. arm Group Labels
    1. defined green tea catechin extract / correlative analysis
    description
    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.
    name
    laboratory biomarker analysis
    type
    OTHER
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
8
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    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
Full study description
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.
Source references
Source notices and limitations
    Discovery and provenance
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        exact text
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        start
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      offset unit
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      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
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      source json pointer
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      source kind
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      source string sha256
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    Preserved source evidence · Not medical advice