Revlimid to Augment Efficacy of Prevnar Vaccines in Patients With Relapsed or Refractory Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- 6B Antibody Response to Prevnar Vaccine in Peripheral Blood
研究概览
简要总结
RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Vaccines may help the body build an effective immune response to kill cancer cells. Giving lenalidomide together with vaccine therapy may make a stronger immune response and kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving lenalidomide together with vaccine therapy works in treating patients with relapsed or refractory multiple myeloma.
详细描述
OBJECTIVES:
Primary
- Determine whether lenalidomide can augment the efficacy of pneumococcal polyvalent vaccine as it correlates with lenalidomide-induced antitumor efficacy in patients with relapsed or refractory multiple myeloma.
Secondary
- Determine the antibody responses to pneumococcal serotypes in patients treated with this regimen.
- Determine T-cell responses to the carrier protein CRM 197 in patients treated with this regimen.
- Determine the ability of lenalidomide to augment in vivo immune responsiveness as measured by cutaneous delayed-type hypersensitivity (DTH) reactions to Candida and tetanus in these patients.
- Determine the ability of lenalidomide to prime and/or boost systemic vaccine responses in both peripheral blood lymphocytes and marrow lymphocytes in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1
Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
干预措施: pneumococcal polyvalent vaccine (Biological)
Group 1
Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
干预措施: lenalidomide (Drug)
Group 2
Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
干预措施: pneumococcal polyvalent vaccine (Biological)
Group 2
Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
干预措施: lenalidomide (Drug)
结局指标
主要结局
6B Antibody Response to Prevnar Vaccine in Peripheral Blood
时间窗: basline and 8 weeks after second vaccination
Serum IgG levels against the PVC serotype were measured by ELISA
23F Antibody Response to Prevnar Vaccine in Peripheral Blood
时间窗: basline and 8 weeks after second vaccination
Serum IgG levels against the PVC serotype were measured by ELISA
14F Antibody Response to Prevnar Vaccine in Peripheral Blood
时间窗: basline and 8 weeks after second vaccination
Serum IgG levels against the PVC serotype were measured by ELISA
19F Antibody Response to Prevnar Vaccine in Peripheral Blood
时间窗: basline and 8 weeks after second vaccination
Serum IgG levels against the PVC serotype were measured by ELISA
次要结局
未报告次要终点