NCT00151203已完成2 期
A Phase II Study of Clarithromycin (Biaxin), Lenalidomide (Revlimid), and Dexamethasone (Decadron) for Newly Diagnosed Subjects With Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Response rate, time to maximum response, toxicities
研究概览
简要总结
PRIMARY STUDY OBJECTIVES
- To evaluate the efficacy of the combination of clarithromycin (Biaxin®), lenalidomide (Revlimid™), and dexamethasone (Decadron®) as an induction therapy for patients with newly diagnosed multiple myeloma (MM).
- To evaluate the safety of the combination of clarithromycin, lenalidomide, and dexamethasone as an induction therapy for patients with newly diagnosed MM.
SECONDARY STUDY OBJECTIVES
- To examine the role of clarithromycin on the pharmacokinetic properties of dexamethasone and lenalidomide.
- To examine the angiogenesis profile in untreated patients and in patients receiving induction therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject must voluntarily sign and understand written informed consent.
- •Histologically confirmed Durie-Salomon stage II or III MM (see Appendix II). Stage I MM patients will be eligible if they display poor prognostic factors (ß2M > or = 5.5 mg/L, plasma cell proliferation index > or = 5%, albumin of less then 3.0, and unfavorable cytogenetics).
- •Measurable disease as defined by > 1.0 g/dL serum monoclonal protein, >0.1 g/dL serum free light chains, > 0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s).
- •Age > or = 18 years at the time of signing the informed consent form.
- •Karnofsky performance status > or = 70% (>60% if due to bony involvement of myeloma (see Appendix V).
- •No prior treatment or less than one full course of first-line therapy. Patients may be receiving adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care.
- •If the patient is a woman of childbearing age, she must have a negative serum or urine pregnancy test within 7 days of starting study.
- •Due to the unknown risk of teratogenic side effects, subjects (women and men) must agree to use effective contraception throughout the duration of the study and for at least 1 month after discontinuation of study drugs.
- •Life expectancy > 3 months
- •Absolute neutrophil count (ANC)> or = 1000 cells/mm3 (1.0 x 109/L)
- •Platelets count > or = 75,000/mm3 (75 x 109/L)
- •Serum SGOT/AST < 3.0 x upper limits of normal (ULN)
- •Serum SGPT/ALT < 3.0 x upper limits of normal (ULN)
- •Serum creatinine < 2.5 mg/dL (221 µmol/L)
- •Serum total bilirubin < 2.0 mg/dL (34 µmol/L)
排除标准
- •Patients with non-secretory MM (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine).
- •Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ³ 5 years.
- •NYHA Class III or IV heart disease. History of active angina, congestive heart disease, or myocardial infarction within 6 months.
- •Pregnant or lactating women are ineligible.
- •Known HIV positivity
- •Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
- •Known hypersensitivity to dexamethasone, clarithromycin, lenalidomide, or thalidomide.
- •Prior therapy for the treatment of MM
- •History of thromboembolic event or other condition currently requiring anticoagulation with warfarin (Coumadin). Patients whose therapy is changed to heparin are eligible.
结局指标
主要结局
Response rate, time to maximum response, toxicities
时间窗: 3 years
次要结局
未报告次要终点
研究者
研究点 (2)
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