NCT00186316已完成1 期
A Phase I/II Study of Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Patient will complete 4 vaccinations of monthly interval
研究概览
简要总结
Patients with Multiple myeloma who have undergone non-myeloablative allogeneic stem cell transplant will receive 6 vaccinations of donor derived dendritic cells combined with specific protein produced by multiple myeloma.
详细描述
To evaluate feasibility and safety of vaccination with allogeneic idiotype-pulsed dendritic cells following mixed chimeric allogeneic transplantation for multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For specimen collection and idiotype protein development:
- •Must be secretory myeloma with at least .5g/dl serum IgG protein
- •Clinically stage 2 or 3 multiple myeloma
- •Karnofsky performance status of 70 or greater
- •2. For Vaccination:
- •Eligible patients must have completed tandem autologous and nonmyeloablative allogeneic transplant for multiple myeloma at Stanford University Medical Center with stable disease or complete response to prevaccine therapy
- •Karnofsky performance status of 70 or greater.
- •ALT and AST must be <2X upper limit of normal. Total bilirubin < 1.5X upper limit of normal.
- •Serum creatinine <1.5X upper limit of normal.
- •Hemoglobin >9g/dl
- •Patients must be HIV negative.
- •Patients must provide signed, informed consent
- •Donor Inclusion Criteria (allo donor is the same donor used for non-myeloablative transplant)
- •Age >17 years
- •HIV negative
- •Must provide signed, informed consent
排除标准
- •For specimen collection and idiotype protein development:
- •Patients with non-secretory myeloma
- •Severe psychological or medical illness
- •Pregnant or lactating women
- •Subjects with > Grade I toxicity by NCI-CTC v 3.0
- •Subjects with prognosis < 6 months
- •2. For Vaccination:
- •< 75 mg of idiotype protein purified from the patients serum
- •< 25 million allogeneic idiotype-pulsed dendritic cells produced for vaccination
- •Evidence of grade II-IV acute GVHD (defined in section 5E)
- •Patients with evidence of myeloma disease progression as (defined below)
- •Severe psychological or medical illness or concomitant medications which may interfere with the study as determined by the clinical investigator
- •Patients on any other investigational agents
- •Pregnant or lactating women
- •Patients on any therapy for multiple myeloma or any chemotherapy drug, or immunomodulatory agent for treatment of multiple myeloma (e.g. thalidomide)
- •Any patient on more than two of the following immunosuppressive agents or at a dose greater than that indicated for a single immunosuppressive agent:
- •Mycophenolate Mofetil (MMF)- no greater than 1000mg twice a day
- •Prednisone- no greater than .5mg/kg/day
- •Cyclosporine- no greater than 300mg/day
- •Tacrolimus (FK506)- no greater than 4mg/day
结局指标
主要结局
Patient will complete 4 vaccinations of monthly interval
次要结局
- Evaluation of immune response. Immune response analysis will be done on all patients who are enrolled in the study. Patients who completed a minimum of 4 vaccinations will be included in immune response.
研究者
研究点 (2)
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