Vaccination In Peripheral Stem Cell Transplant Setting For Multiple Myeloma: The Use Of Autologous Tumor Cells/An Allo PSCT
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Tumor-specific immune response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Combining chemotherapy with vaccine therapy and peripheral stem cell transplantation may be effective in treating multiple myeloma.
PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy followed by vaccine therapy and peripheral stem cell transplantation in treating patients who have newly diagnosed multiple myeloma.
详细描述
OBJECTIVES:
- Determine the efficacy of induction chemotherapy followed by autologous tumor cell vaccine and autologous peripheral blood stem cell transplantation in patients with multiple myeloma.
- Determine the safety of this regimen in these patients.
OUTLINE: Autologous tumor cells are harvested. The vaccine is prepared in vitro by mixing autologous tumor cells with a bystander cell expressing sargramostim (GM-CSF). Patients receive induction chemotherapy followed by autologous tumor cell vaccination (ATCV) once. Patients then undergo autologous peripheral blood stem cell transplantation. At 6 weeks after transplantation, patients receive additional ATCVs every 3 weeks for a total of 8 vaccinations.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Initial Presentation
- •Age between 18 and 70 years
- •ECOG 0 - 2
- •Patients with histologically confirmed multiple myeloma with ≥ 30% bone
- •marrow involvement and a de novo presentation. One cycle of prior
- •chemotherapy for myeloma is allowed. Local radiation therapy is permitted
- •Ability to give informed consent
- •No existing secondary malignancies and no history of secondary malignancies in the past 5 years (other than a history of carcinoma in situ of the cervix, superficial skin cancer, or superficial bladder cancer)
- •No active autoimmune disease, nor a history of any autoimmune disease requiring medical treatment with systemic immunosuppressants
- •No corticosteroids within 28 days of tumor harvest
- •No major active medical or psychosocial problems that could be exacerbated or complicated by this treatment
- •Not pregnant
- •HIV negative
- •AST/ALT, total bilirubin < threefold normal
- •Absolute neutrophil count >500/mm3
- •Platelet count >30,000/mm3
- •Prior to Transplantation
- •ECOG performance status of 0 -
- •No active/uncontrolled infection.
- •Absolute neutrophil count (ANC) >1000/mm
- •Platelet count >50,000/mm
- •Hemoglobin >8g/dL
- •AST/ALT, total bilirubin <3-fold normal.
- •50% or greater reduction in tumor burden with prior chemotherapy
- •Patient has received a minimum of 2 cycles of an accepted induction
- •chemotherapy regimen
- •Patient fulfills the requirements for standard peripheral stem cell transplantation Prior to Posttransplant Vaccination
- •No active/uncontrolled infection
- •Absolute neutrophil count (ANC) >1000/mm3
- •Platelet count >50,000/mm3
- •Hemoglobin >8g/dL
- •AST/ALT, total bilirubin <3-fold normal
- •No unresolved Grade 3 or 4 adverse events related to the transplant
排除标准
- •Failure of autologous tumor-cell processing for vaccine production
研究组 & 干预措施
Vaccine
Participants are vaccinated with GVAX one month or more after finishing induction therapy (which is given as per standard of care). Two weeks later, participants go through leukapheresis on protocol, then receive autologous transplant as per standard of care. GVAX is administered eight subsequent times after the autologous transplant.
干预措施: Autologous transplant (Procedure)
Vaccine
Participants are vaccinated with GVAX one month or more after finishing induction therapy (which is given as per standard of care). Two weeks later, participants go through leukapheresis on protocol, then receive autologous transplant as per standard of care. GVAX is administered eight subsequent times after the autologous transplant.
干预措施: GVAX (Biological)
结局指标
主要结局
Tumor-specific immune response
时间窗: Up to 1 year
Percentage of participants who had a delayed-type hypersensitivity reaction with induration greater than or equal to 5 millimeters to an intradermal injection of irradiated autologous tumor cells.
次要结局
- Grade 3-4 toxicity(Up to 1 year)