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
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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 |
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 (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 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
New or prior diagnosis of 1 of the following:
-
Monoclonal gammopathy of undetermined significance
- Bone marrow plasma cells of less than 10%
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Monoclonal gammopathy of borderline significance
- Bone marrow plasma cells of 10-30%
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- 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

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
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 |
Study Chair: | John A. Lust, MD, PhD | Mayo Clinic |
Responsible Party: | John A. Lust, M.D., Mayo Clinic Cancer Center |
ClinicalTrials.gov Identifier: | NCT00006219 |
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 |
multiple myeloma |
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 |