NCT00049374已完成2 期
A Phase II Study Of Genasense In Combination With Thalidomide And Dexamethasone In Relapsed And Refractory Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Complete and partial remission
研究概览
简要总结
RATIONALE: Thalidomide may slow the growth of cancer cells. Oblimersen may increase the effectiveness of thalidomide and dexamethasone by making cancer cells more sensitive to the drugs.
PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and dexamethasone with oblimersen in treating patients who have relapsed or refractory multiple myeloma.
详细描述
OBJECTIVES:
- Determine the clinical efficacy of oblimersen, thalidomide, and dexamethasone, in terms of complete and partial response rates, in patients with relapsed or refractory multiple myeloma.
- Determine the time to progression and duration of response in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Correlate disease response (clinical outcome) with changes in Bcl-2 levels in patients treated with this regimen.
- Determine the disease-free and overall survival of patients treated with this regimen.
OUTLINE: Patients receive induction therapy comprising oblimersen IV continuously on days 1-7, 22-28, and 43-49, oral dexamethasone on days 4-7, 25-28, and 46-49, and oral thalidomide daily beginning on day 4. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients with stable disease after induction therapy receive maintenance therapy comprising oblimersen IV continuously on days 1-7, oral dexamethasone on days 4-7, and oral thalidomide daily. Courses repeat every 35 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Patients are followed for 3 years.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically and clinically confirmed multiple myeloma
- •Relapsed and/or refractory after chemotherapy or transplantation
- •Patients with prior allogeneic transplantation must not have evidence of active graft-vs-host disease requiring immune suppression
- •Measurable disease defined by quantitative immune globulin levels in serum and/or urine and bone marrow plasmacytosis
- •Patients with nonsecretory disease are eligible provided at least 1 plasmacytoma lesion is accurately measurable by MRI or CT scan
- •No known CNS involvement
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •See Disease Characteristics
- •Absolute neutrophil count at least 1,000/mm^3*
- •Platelet count at least 50,000/mm^3* NOTE: *Unless secondary to bone marrow plasmacytosis (more than 80% involvement)
- •Bilirubin less than 2 times normal
- •AST/ALT no greater than 3 times upper limit of normal
- •Creatinine no greater than 2 mg/dL
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Seizures allowed if under adequate control
- •No severe skin reactions from prior thalidomide
- •No prior allergic reactions attributed to agents used in this study
- •No sensory or motor neuropathy grade II or greater
- •No other uncontrolled concurrent illness that would preclude study therapy
- •No ongoing or active infection
- •No psychiatric illness or social situations that would preclude study compliance
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use 2 effective methods of contraception for 1 month before, during, and for 1 month after study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •See Chemotherapy
- •At least 6 weeks since prior thalidomide
- •Chemotherapy
- •See Disease Characteristics
- •No more than 4 prior chemotherapy regimens, including autologous and/or allogeneic stem cell transplantation regimens
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •Endocrine therapy
- •Concurrent continuous steroids allowed for chronic treatment of disorders other than myeloma
- •Radiotherapy
- •Not specified
- •Not specified
- •No prior oblimersen
- 另有 2 项未显示
排除标准
- 未提供
结局指标
主要结局
Complete and partial remission
次要结局
- Relationship between molecular and clinical outcomes
研究者
研究点 (2)
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