NCT00006219已完成2 期
A Phase II Clinical Trial of Dehydroepiandrosterone and Biaxin in Monoclonal Gammopathy of Undetermined and Borderline Significance
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 试验地点
- 6
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •See Disease Characteristics
- •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)
- •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
- •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
- •Not specified
- •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
排除标准
- 未提供
研究者
研究点 (6)
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