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

NCT00942422 | Terminated Phase 2 Results DMC

• 3 other identifiers: CDR0000646899P30CA022453WSU-2009-015
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm; Precancerous Condition

Keywords

monoclonal gammopathy of undetermined significance; smoldering multiple myeloma

Outcome Measures

Primary Outcomes (1)

• 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.

  Day one of each 28-day cycle for a total of up to 6 cycles

Study Arms (1)

defined green tea catechin extract / correlative analysis

EXPERIMENTAL

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; Genetic: gene expression analysis; Genetic: protein analysis; Other: laboratory biomarker analysis

Interventions

defined green tea catechin extract DIETARY_SUPPLEMENT

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 / correlative analysis

gene expression analysis GENETIC

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.

defined green tea catechin extract / correlative analysis

protein analysis GENETIC

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.

defined green tea catechin extract / correlative analysis

laboratory biomarker analysis OTHER

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.

defined green tea catechin extract / correlative analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell; Precancerous Conditions; Monoclonal Gammopathy of Undetermined Significance; Smoldering Multiple Myeloma

Interventions

Gene Expression Profiling

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Hypergammaglobulinemia

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques

Limitations and Caveats

Low accrual and early termination limits the conclusions one could draw. Although no pts on this trial met the primary endpoint of a 25% or greater M-protein reduction, the small number of pts enrolled prohibits formal statistical analysis.

Results Point of Contact

• Title: Jeffrey Zonder, M.D.
• Organization: Barbara Ann Karmanos Cancer Institute

zonderj@karmanos.org

313-576-8732

Study Officials

• Jeffrey A. Zonder, MD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 17, 2009
• First Posted: July 20, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 27, 2015
• Results First Posted: March 27, 2015

Record last verified: 2015-03

Locations

US (1)