Chemoprevention Therapy in Treating Patients at High Risk of Developing Multiple Myeloma
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: clarithromycin Drug: prasterone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind 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 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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%
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| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | John A. Lust, M.D., Mayo Clinic Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00006219 History of Changes |
| Other Study ID Numbers: | CDR0000068084, P30CA015083, 979202 |
| Study First Received: | September 11, 2000 |
| Last Updated: | August 2, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Mayo Clinic:
|
multiple myeloma |
Additional relevant MeSH terms:
|
Neoplasms Paraproteinemias Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Blood Protein Disorders Hematologic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Hemorrhagic Disorders |
Lymphoproliferative Disorders Dehydroepiandrosterone Clarithromycin Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013