NCT01858558已完成2 期
Randomized Phase II Study of Autologous Stem Cell Transplantation With Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2013年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product
研究概览
简要总结
This research is being done to find out if altering the immune system by giving activated marrow infiltrating lymphocytes (MILs) can improve outcomes for multiple myeloma patients who receive a standard autologous stem cell transplant.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 80 years old;
- •Patients with active myeloma requiring systemic treatment;
- •Newly diagnosed patients. Relapsed myeloma patients that have not previously had a transplant;
- •Meeting criteria for high-risk disease;
- •Measurable serum and/or urine M-protein from prior to induction therapy documented and available. A positive serum free lite assay is acceptable;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 (see Appendix C).
- •Meet all institutional requirements for autologous stem cell transplantation;
- •The patient must be able to comprehend and have signed the informed consent;
- •Patients must have had > than PR after last therapy.
排除标准
- •Diagnosis of any of the following cancers:
- •POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M-protein] and skin changes);
- •Non-secretory myeloma (no measurable protein on Serum Free Lite Assay);
- •Plasma cell leukemia;
- •Diagnosis of amyloidosis;
- •Failed to achieve at least a partial response (PR) to latest therapy;
- •Previous hematopoietic stem cell transplantation;Patients can have had prior relapsed disease as long as they have never been previously transplanted;
- •Known history of HIV infection;
- •Use of corticosteroids (glucocorticoids) within 21 days of bone marrow collection;
- •Use of any myeloma-specific therapy within 21 days of bone marrow collection;
- •Infection requiring treatment with antibiotics, antifungal, or antiviral agents within seven days of registration;
- •Participation in any clinical trial within 28 days of registration on this trial, which involved an investigational drug or device;
- •History of malignancy other than multiple myeloma within five years of registration, except adequately treated basal or squamous cell skin cancer;
- •Active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis) requiring active systemic treatment. Hypothyroidism without evidence of Grave's disease or Hashimoto's thyroiditis is permitted.
- •Human T-lymphotropic virus (HTLV) 1 or 2 positive;
- •Known hypersensitivity to Prevnar or any of its components;
- •Contraindication to phosphodiesterase-5 inhibitors (e.g. currently on nitrates).
研究组 & 干预措施
aMIL Arm
Experimental
Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)
干预措施: aMIL (Biological)
aMIL Arm
Experimental
Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)
干预措施: No aMIL (Drug)
No aMIL
Active Comparator
Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)
干预措施: No aMIL (Drug)
结局指标
主要结局
Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product
时间窗: 120 days
Feasibility is defined as the ability to harvest, expand, and infuse the MILs product within 120 days. After treating 60 patients with MILs, we will declare MILs not feasible if we can only harvest, expand, and deliver MILs to 40 or fewer patients.
次要结局
- Progression-free Survival (PFS)(5 years)
- Toxicity as Determined by Total Number of Grade 3 or Higher Adverse Events(60 days from aMILs harvest until day 60 after transplant)
- Overall Survival (OS)(3 years)
研究者
研究点 (1)
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