NCT00022607已完成2 期
Phase II Randomized Trial of Bevacizumab Versus Bevacizumab and Thalidomide for Relapsed/Refractory Multiple Myeloma
California Cancer Consortium8 个研究点 分布在 1 个国家开始时间: 2002年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 8
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. It is not yet known whether bevacizumab works better with or without thalidomide for multiple myeloma.
PURPOSE: This randomized phase II trial is to see if bevacizumab works better with or without thalidomide in treating patients who have relapsed or refractory multiple myeloma.
详细描述
OBJECTIVES:
- Compare the response rate and time to progression in patients with relapsed or refractory multiple myeloma treated with bevacizumab with or without thalidomide.
- Compare the toxicity of these regimens in these patients.
- Compare the effects of these regimens on histological and molecular biomarkers of angiogenesis, tumor invasion, and cell death in these patients.
- Correlate plasma and urine vascular endothelial growth factor and basic fibroblast growth factor levels and other potential markers of angiogenesis and myeloma cell proliferation with outcome in patients treated with these regimens.
- Determine the pharmacokinetics of thalidomide in these patients.
- Compare the effects of these regimens on the psychological/physical well being of these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior treatment with thalidomide (yes vs no).
Patients who have received no prior treatment with thalidomide are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43. Patients also receive oral thalidomide once daily.
- Arm II: Patients receive bevacizumab as in arm I. Patients who have received prior treatment with thalidomide receive bevacizumab as in arm I.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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:
- •Histologically confirmed progressing multiple myeloma
- •Stages I, II, or III
- •More than 25% increase in urine or plasma paraprotein levels
- •More than 5% malignant plasma cell involvement in bone marrow
- •Smoldering myeloma is eligible provided there is evidence of progressive disease requiring therapy
- •At least 25% increase in M protein levels or Bence Jones excretion
- •Hemoglobin no greater than 10.5 g/dL
- •Frequent infections
- •Hypercalcemia
- •Rise in serum creatinine above normal on 2 separate occasions
- •Nonsecretory multiple myeloma that is bidimensionally measurable by MRI or CT scan is eligible provided the disease site is new or has shown an increase in M protein levels or Bence Jones excretion is greater than 30% from baseline
- •No prior or concurrent CNS involvement with primary or metastatic tumor
- •No nonquantifiable monoclonal proteins or IgM peaks unless there is evidence of bidimensionally measurable disease by MRI or CT scan
- •No history of hemorrhagic tumor or hemorrhagic metastasis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •See Disease Characteristics
- •Absolute neutrophil count ≥1,000/mm^3
- •Platelet count ≥ 50,000/mm^3
- •No hemorrhagic illness within the past 3 weeks
- •Bilirubin ≤ 1.5 mg/dL
- •SGOT/SGPT≤ 2.5 times upper limit of normal (ULN)
- •INR ≤ 1.5
- •aPTT < 1.5 times ULN
- •See Disease Characteristics
- •Creatinine ≤ 2 mg/dL
- •Creatinine clearance ≥ 40 mL/min
- •Calcium ≤ 12 mg/dL
- •No nephrotic syndrome
- •Cardiovascular:
- •No active coronary artery disease
- •No New York Heart Association class II-IV congestive heart failure
- •No grade II or greater peripheral vascular disease (i.e, ischemic rest pain, non-healing ulcer, or tissue loss)
- •No uncontrolled hypertension
- •No history of deep venous thrombosis
- •No vascular illness within the past 3 weeks
- •No arterial thromboembolic event within the past 6 months, including any of the following:
- •Transient ischemic attack
- •Cerebrovascular accident
- •Unstable angina
- •Myocardial infarction
- •No history of pulmonary embolus
- •No other prior malignancy unless the patient has been in complete remission for at least 2 years
- •No peripheral neuropathy or CNS abnormalities ≥ grade 2
- 另有 36 项未显示
排除标准
- 未提供
研究者
研究点 (8)
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