UARK 2005-01, A Phase III Study of Velcade, Thalidomide, and Dexamethasone (VTD) With or Without Adriamycin® in Relapsed/Refractory Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Evaluate the effectiveness of the combination of these drugs
研究概览
简要总结
The main goal of this study is to evaluate the effectiveness of the combination of these drugs, and whether they can be given safely together.
详细描述
In this study, there will be two arms (or groups). One arm will receive Velcade, thalidomide, and dexamethasone (VTD), and the other arm will receive VTD with Adriamycin.
This study has the following specific goal:
To evaluate the efficacy and toxicity of two treatments in multiple myeloma patients, relapsing after at least one course of high-dose treatment and an autologous stem cell transplant, or after at least two lines of conventional chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients with relapsing multiple myeloma (MM)
- •Patients must have adequate platelet count of > 20,000 x 10^9/L, independent of transfusions, unless it is due to massive myeloma infiltration.
- •Anticipated life expectancy of at least 3 months
- •Ejection fraction by echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan performed within 60 days prior to registration; left ventricular ejection fraction (LVEF) > 40% by ECHO or MUGA.
- •Female patients of child bearing age are required to have a negative pregnancy test as indicated in thalidomide safety guidelines
- •Patients must have a performance status of 0-2 based on Southwest Oncology Group (SWOG) criteria. Patients with a poor performance status (3-4), based solely on bone pain, will be eligible.
- •All patients must be informed of the investigational nature of this study and must have signed an institutional review board (IRB)-approved informed consent in accordance with institutional and federal guidelines.
排除标准
- •Evidence of central nervous system (CNS) involvement
- •Grade > 2 peripheral neuropathy
- •Hypersensitivity to Velcade, boron, or mannitol
- •Recent (< 6 months) myocardial infarction, cerebrovascular accident (CVA)/stroke, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias.
- •Evidence of chronic obstructive or chronic restrictive pulmonary disease.
- •Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years.
- •Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection.
- •Pregnant or nursing women. Women of child-bearing potential must have a negative pregnancy test documented within one week of registration. Women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of the study treatment.
研究组 & 干预措施
1
Stratification:
- CA13/hypodiploidy at diagnosis versus no CA13/hypoploidy at diagnosis
- Prior Velcade vs. No prior Velcade
TREATMENT:VTD Velcade 1.0 mg/m2 Days 1,4, 8,11 Thalidomide 100 mg Daily qhs Dexamethasone 20 mg Days 1, 2, 4,5, 8, 9, 11, 12 Lovenox 40 mg Days 1-14 Every 21 days
干预措施: Velcade, Thalidomide, Dexamethasone (Drug)
2
Stratification:
- CA13/hypodiploidy at diagnosis versus no CA13/hypoploidy at diagnosis
- Prior Velcade vs. No prior Velcade
TREATMENT:
VATD Velcade 1.0 mg/m2 Days 1,4, 8,11 Thalidomide 100 mg Daily qhs Dexamethasone 20 mg Days 1, 2, 4,5, 8, 9, 11, 12 Adriamycin 2.5 mg/m2 Days 1-4 & Days 9-12 Lovenox 40 mg Days 1-14 Every 21 days
干预措施: Velcade, Thalidomide, Dexamethasone (Drug)
结局指标
主要结局
Evaluate the effectiveness of the combination of these drugs
时间窗: 168 days
次要结局
- Evaluate the efficacy and toxicity of two treatments in multiple myeloma patients, relapsing after at least one course of high-dose treatment and an autologous stem cell transplant(168 days)