NCT00616720已完成2 期
Randomized Phase II Trial of Dendritic Cell-Based Idiotype Vaccination With Adjuvant Cytokines for Plateau Phase and Post-Transplant Multiple Myeloma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 15
- 主要终点
- Confirmed response (i.e., clinical or immunological)
研究概览
简要总结
RATIONALE: Biological therapies, such as interferon-gamma and aldesleukin, may stimulate the immune system in different ways and stop cancer cells from growing. Vaccines made from a person's white blood cells may help the body build an effective immune response to kill cancer cells. Giving biological therapy together with vaccine therapy may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying how well giving aldesleukin or interferon gamma together with vaccine therapy works in treating patients with multiple myeloma.
详细描述
OBJECTIVES:
Primary
- To assess the clinical benefit in patients with plateau phase multiple myeloma treated with interferon-gamma vs aldesleukin in combination with idiotype-pulsed autologous dendritic cell vaccine APC8020.
- To describe response rates in patients who are in plateau phase status post-chemotherapy or status post-peripheral blood cell transplantation treated with this regimen.
Secondary
- To obtain data regarding the ability of this approach to produce an anti-idiotypic immunologic response.
- To obtain information about the effects of interferon-gamma and aldesleukin on the number, function, and activation state of immune effector-cells including T-cells and B-cells.
- To perform detailed analyses of lymphocyte phenotypes and T-cell repertoires before and after idiotype-pulsed autologous dendritic cell vaccine APC8020.
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:
- •Diagnosis of multiple myeloma
- •Plateau phase multiple myeloma (status post chemotherapy or status post-peripheral blood cell transplantation), meeting the following criteria:
- •Serum and urine monoclonal (M) protein values must be stable (< 20% variation) or must have disappeared
- •Serum M protein < 1 g/dL, and 1 of the following:
- •Quantifiable serum M protein
- •Adequate serum sample stored in Transfusion Medicine under IRB protocol #698-98
- •Urine M protein < 200 mg/24 hours by electrophoresis on 2 separate occasions for a period of ≥ 4 weeks
- •Serum M protein spike ≤ 2.0 g/dL
- •No progressive disease after prior autologous stem cell transplantation or chemotherapy
- •No non-secretory or light chain myeloma
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 6 months
- •WBC ≥ 1,500/μL
- •Platelet count ≥ 50,000/μL
- •Total bilirubin ≤ 5 times upper limit of normal
- •Creatinine ≤ 5.0 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Must have adequate venous access for apheresis
- •No uncontrolled cardiac disease
- •No uncontrolled infection
- •No illness or condition which, in the opinion of the investigator, may affect safety of treatment or evaluation of any of the study's endpoints
- •PRIOR CONCURRENT THERAPY:
- •Recovered from all prior therapy
- •More than 4 weeks since prior standard-dose chemotherapy, radiotherapy, or immunotherapy
- •More than 3 months since prior high-dose chemotherapy with stem cell transplantation
- •No concurrent corticosteroids
排除标准
- 未提供
结局指标
主要结局
Confirmed response (i.e., clinical or immunological)
次要结局
未报告次要终点
研究者
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