search
Back to results

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

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
defined green tea catechin extract
gene expression analysis
protein analysis
laboratory biomarker analysis
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring monoclonal gammopathy of undetermined significance, smoldering multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

defined green tea catechin extract / correlative analysis

Arm 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.

Outcomes

Primary Outcome Measures

Sustained M-protein Reduction of ≥ 25% From Baseline
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.

Secondary Outcome Measures

Full Information

First Posted
July 17, 2009
Last Updated
March 18, 2015
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00942422
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Low accrual and early termination
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition
Keywords
monoclonal gammopathy of undetermined significance, smoldering multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
defined green tea catechin extract / correlative analysis
Arm Type
Experimental
Arm 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 Type
Dietary Supplement
Intervention Name(s)
defined green tea catechin extract
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.
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention 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.
Intervention Type
Genetic
Intervention Name(s)
protein analysis
Intervention 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.
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention 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.
Primary Outcome Measure Information:
Title
Sustained M-protein Reduction of ≥ 25% From Baseline
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.
Time Frame
Day one of each 28-day cycle for a total of up to 6 cycles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A. Zonder, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs