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NCT00942422 · OUTCOME

Sustained M-protein Reduction of ≥ 25% From Baseline

Green Tea Extract in Treating Patients With Monoclonal Gammopathy of Undetermined Significance and/or Smoldering Multiple Myeloma · Source last updated 2015-03-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
Time frame
Day one of each 28-day cycle for a total of up to 6 cycles

What was measured

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.

Groups in this outcome

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. 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. 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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Defined Green Tea Catechin Extract / Correlative Analysis8

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Defined Green Tea Catechin Extract / Correlative Analysis0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
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.
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. 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. 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
    id
    OG000
    title
    Defined Green Tea Catechin Extract / Correlative Analysis
param Type
NUMBER
reporting Status
POSTED
time Frame
Day one of each 28-day cycle for a total of up to 6 cycles
title
Sustained M-protein Reduction of ≥ 25% From Baseline
type
PRIMARY
unit Of Measure
percentage of patients

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice