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

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ClinicalTrials.gov Identifier: NCT00006219
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 4, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Drug: clarithromycin Drug: prasterone Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Official Title: A Phase II Clinical Trial of Dehydroepiandrosterone and Biaxin in Monoclonal Gammopathy of Undetermined and Borderline Significance
Study Start Date : August 2000
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006219


Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Study Chair: John A. Lust, MD, PhD Mayo Clinic
More Information
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Responsible Party: John A. Lust, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00006219     History of Changes
Other Study ID Numbers: CDR0000068084
P30CA015083 ( U.S. NIH Grant/Contract )
979202 ( Other Identifier: Mayo Clinic Cancer Center )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: August 2011

Keywords provided by Mayo Clinic:
multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
 Immune System Diseases
Clarithromycin
Dehydroepiandrosterone
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs