NCT00378768已完成2 期
A Phase II Study of Thymoglobulin in Patients With Multiple Myeloma Who Are Candidates for Allogeneic or Autologous Stem Cell Transplant
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Response rate, as measured by International Bone Marrow Transplant Registry (IBMTR)/European Group for Blood and Marrow Transplantation (EBMT) Response Criteria, at 4 weeks
研究概览
简要总结
RATIONALE: Biological therapies, such as antithymocyte globulin, may stimulate the immune system in different ways and stop cancer cells from growing.
PURPOSE: This phase II trial is studying how well antithymocyte globulin works in treating patients undergoing stem cell transplant for multiple myeloma.
详细描述
OBJECTIVES:
Primary
- Determine the response rate at 4 weeks in patients with multiple myeloma treated with anti-thymocyte globulin at least 4 to 6 weeks prior to undergoing conditioning therapy for allogeneic or autologous stem cell transplantation.
Secondary
- Determine the toxicity of this drug, in terms of formation of antirabbit antibodies, in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed multiple myeloma
- •Candidate for autologous or allogeneic stem cell transplantation within 1 to 3 months after study treatment
- •Measurable disease, defined as serum monoclonal protein ≥ 1 g/dL OR urinary light chain excretion = 500 mg/24 hours
- •No malignant CNS disease
- •PATIENT CHARACTERISTICS:
- •Life expectancy ≥ 6 months
- •Absolute neutrophil count ≥ 1,000/mm³
- •Platelet count > 50,000/mm³
- •Creatinine ≤ 2 mg/dL
- •Hepatic function ≤ 2 times upper limit of normal
- •DLCO ≥ 50%
- •No active infection
- •No hypersensitivity to rabbit proteins
- •No symptomatic hyperviscosity syndrome
- •Negative pregnancy test
- •PRIOR CONCURRENT THERAPY:
- •More than 28 days since prior chemotherapy, including prednisone (20 mg equivalent/day)
- •No prior anti-thymocyte globulin
- •No concurrent radiotherapy
排除标准
- 未提供
结局指标
主要结局
Response rate, as measured by International Bone Marrow Transplant Registry (IBMTR)/European Group for Blood and Marrow Transplantation (EBMT) Response Criteria, at 4 weeks
次要结局
- Toxicity as assessed by NCI CTC v2.0
- Formation of antirabbit antibodies
研究者
研究点 (1)
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