Clinical trial · Interventional
Green Tea Extract in Treating Patients With Monoclonal Gammopathy of Undetermined Significance and/or Smoldering Multiple Myeloma
The Clinical and Biologic Evaluation of Polyphenon E, an Extract of Green Tea Containing EGCG, in Plasma Cell Dyscrasias - Pilot Study
NCT00942422CI-TRIAL-00017287terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual and early termination
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| defined green tea catechin extract | Dietary Supplement | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| protein analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Dietary Supplement: defined green tea catechin extract
- Genetic: gene expression analysis
- Genetic: protein analysis
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Sustained M-protein Reduction of ≥ 25% From Baseline
- timeFrame
- Day one of each 28-day cycle for a total of up to 6 cycles
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.