NCT00389701Unknown2 期
Phase II Trial of Twice Weekly Induction Followed by Once Weekly IV Velcade (Bortezomib) With Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Following at Least 1 Prior Therapy
Sparrow Regional Cancer Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2006年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Overall response rate
研究概览
简要总结
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with dexamethasone may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with dexamethasone works in treating patients with multiple myeloma that has relapsed or has not responded to treatment.
详细描述
OBJECTIVES:
Primary
- Determine the overall response rate (complete response and partial response) in patients with relapsed or refractory multiple myeloma treated with induction therapy and maintenance therapy comprising bortezomib and dexamethasone.
Secondary
- Determine the toxicity of this regimen in these patients
- Determine the tolerability of this regimen in these patients.
- Determine the duration of response in patients treated with this regimen.
- Determine time to progression in patients treated with this regimen.
- Determine overall and progression-free survival of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of multiple myeloma
- •Refractory or relapsed disease meeting the following criteria:
- •Primary refractory disease and first-line relapsing disease
- •Progressive disease after last therapy
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy > 3 months
- •Platelet count ≥ 50,000/mm³ (≥ 30,000/mm³ for patients with significant bone marrow involvement)
- •Transfusions allowed
- •Hemoglobin ≥ 7.5 g/dL
- •Absolute neutrophil count ≥ 750/mm³
- •Serum calcium < 14 mg/dL
- •AST and ALT < 2.5 times upper limit of normal
- •Creatinine clearance ≥ 30 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No peripheral neuropathy ≥ grade 2 within the past 14 days
- •No hypersensitivity to boron or mannitol
- •No cardiovascular complications, including any of the following:
- •Myocardial infarction within the past 6 months
- •New York Heart Association class III-IV heart failure
- •Uncontrolled angina
- •Ventricular arrhythmias
- •Electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- •Cardiac amyloidosis
- •No other cancer or treatment for cancer other than basal cell cancer of the skin within the past 5 years
- •No poorly controlled chronic diseases (e.g., diabetes mellitus or hypertension)
- •No HIV positivity
- •No hepatitis B surface antigen or active hepatitis C infection
- •No active systemic infection requiring therapy
- •No serious medical or psychiatric illness that would interfere with study participation
- •PRIOR CONCURRENT THERAPY:
- •No plasmapheresis within the past 4 weeks
- •No major surgery within the past 4 weeks
- •No prior bortezomib
- •No chemotherapy (e.g., clarithromycin) within the past 4 weeks
- •No radiotherapy within the past 3 weeks
- •No corticosteroids (> 10 mg/day of prednisone or equivalent) within the past 3 weeks
- •No other immunotherapy within the past 8 weeks
- •No other investigational drugs within the past 14 days
- •No concurrent participation in other clinical research studies
排除标准
- 未提供
结局指标
主要结局
Overall response rate
次要结局
- Tolerability
- Duration of response after completion of treatment
- Time to progression
- Overall and progression-free survival
- Toxicity
研究者
研究点 (2)
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