Chemoprevention Therapy in Treating Patients at High Risk of Developing Multiple Myeloma

August 2, 2011 updated by: Mayo Clinic

A Phase II Clinical Trial of Dehydroepiandrosterone and Biaxin in Monoclonal Gammopathy of Undetermined and Borderline Significance

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Dehydroepiandrosterone and clarithromycin may be effective in preventing multiple myeloma.

PURPOSE: Randomized phase II trial to compare the effectiveness of dehydroepiandrosterone with that of clarithromycin in treating patients who may be at a high risk of developing multiple myeloma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine whether dehydroepiandrosterone (DHEA) or clarithromycin causes a significant reduction in bone marrow plasmacytosis, serum and/or urine M protein or Bence Jones protein, and surrogate endpoint biomarkers in patients with monoclonal gammopathy of undetermined or borderline significance.
  • Determine whether differences in interleukin-1-beta (IL-1-beta) expression and IL-1-beta dependent biomarkers (adhesion molecule expression and serum interleukin-6 levels) are useful surrogate endpoint biomarkers in these patients.
  • Determine whether differences in ploidy, proliferative index, nuclear pleomorphism index, circulating monoclonal plasma cells, Th1/Th2 ratios, serum s-interleukin-6R (SIL-6R) levels, interleukin-6 and SIL-6R expression, or plasma cell apoptosis assay are useful surrogate endpoint biomarkers in these patients.
  • Determine the effects of these treatment regimens on the quality of life of these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to disease (monoclonal gammopathy of undetermined significance vs monoclonal gammopathy of borderline significance) and monoclonal protein abnormality (IgG vs IgA). Patients are randomized to 1 of 4 treatment arms.

  • Arm I: Patients receive oral dehydroepiandrosterone (DHEA) once daily.
  • Arm II: Patients receive oral clarithromycin once or twice daily.
  • Arm III: Patients receive oral placebo once daily.
  • Arm IV: Patients receive oral placebo twice daily. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, 6 months, 12 months, and then at disease progression.

Patients are followed every 3 months for 1 year and then every 6 months for 1.5 years.

PROJECTED ACCRUAL: A total of 75 patients (25 per treatment arms I and II and 25 between arms III and IV) will be accrued for this study within 2.5 years.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • New or prior diagnosis of 1 of the following:

    • Monoclonal gammopathy of undetermined significance

      • Bone marrow plasma cells of less than 10%

    • Monoclonal gammopathy of borderline significance

      • Bone marrow plasma cells of 10-30%
  • Serum IgG or IgA at least 1.5 g/dL
  • Bone marrow plasmacytosis no greater than 30%
  • No multiple myeloma, amyloidosis, or B-cell neoplasm
  • No evidence of bone lesions
  • Prostate-specific antigen less than 4 ng/mL

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless history of Gilbert's disease)
  • AST and ALT no greater than 1.5 times ULN (unless history of Gilbert's disease)

Renal:

  • Creatinine no greater than 1.8 mg/dL

Cardiovascular:

  • No New York Heart Association class III or IV heart disease
  • No prior thromboembolic event within the past 5 years

Other:

  • No prostate cancer or clinically significant benign prostatic hypertrophy
  • No prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No malignancy suspected on mammogram
  • No hypersensitivity to DHEA, clarithromycin, or any macrolide antibiotic (e.g., erythromycin)
  • No insulin-dependent diabetes
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier method of contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • At least 30 days since prior DHEA or other steroids that may affect M protein

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • At least 30 days since prior clarithromycin
  • At least 30 days since any other prior agents that may affect M protein
  • No concurrent cisapride, terfenadine, pimozide, astemizole, or loratadine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: John A. Lust, MD, PhD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)

December 1, 2006

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

August 4, 2011

Last Update Submitted That Met QC Criteria

August 2, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068084
  • P30CA015083 (U.S. NIH Grant/Contract)
  • 979202 (OTHER: Mayo Clinic Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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