临床试验/NCT01995708

NCT01995708已完成1 期

A Phase I Trial of Vaccination With CT7, MAGE-A3, and WT1 mRNA-electroporated Autologous Langerhans-type Dendritic Cells as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation

Memorial Sloan Kettering Cancer Center1 个研究点分布在 1 个国家目标入组 28 人开始时间: 2014年1月31日最近更新: 2024年2月9日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Memorial Sloan Kettering Cancer Center
入组人数: 28
试验地点: 1
主要终点: Number of Participants Evaluated for Vaccine Safety

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to see if the investigator can help the immune system to work against myeloma.

This study will see if a vaccine made with altered dendritic cells will make T cells work against tumor cells. The stem cells collected for the transplant will also be used to grow dendritic cells in the lab. The dendritic cells will carry the antigens. These cells then will be injected under the skin. The investigators will do lab studies before and after the vaccination to find out if the vaccine is working.

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

•Symptomatic multiple myeloma, ISS stages I-III, within 12 months of starting therapy.
•Completion of induction therapy with Very Good Partial Response (VGPR), or better, by International Myeloma Working Group (IMWG) criteria.
•Deemed eligible for ASCT by standard institutional criteria.
•Age ≥18 years.
•Documentation of CT7, MAGE-A3, or WT1 expression in the bone marrow and/or bone marrow aspirate.

排除标准

•Prior autologous or allogeneic SCT.
•Previous immunization against CT7, MAGE-A3, other cancer-testis antigens, or WT
•Known immunodeficiency, HIV positivity, hepatitis B, or hepatitis C.
•History of autoimmune disease (e.g., rheumatoid arthritis, SLE), other than vitiligo, diabetes, or treated thyroiditis, which are allowed.
•History of severe allergic reactions to vaccines or unknown allergens.
•Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first immunization.
•Lenalidomide-related toxicities before ASCT necessitating its discontinuation as part of treatment.

结局指标

主要结局

Number of Participants Evaluated for Vaccine Safety

时间窗: 1 year

Participants will be evaluated for the safety of the vaccine, monitored and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 for toxicity and adverse event reporting to the Food and Drug Administration. Dose limiting toxicity (DLT) is defined as grade 3 or higher toxicity. The only toxicities captured outside of the SAEs reported will be all grade 1-5 toxicites deemed definitely, probably, or possibly related to the vaccine portion of the study.

次要结局

Median Progression Free Survival(Up to 7 years)

研究者

发起方

Memorial Sloan Kettering Cancer Center

申办方类型

Other

责任方

Sponsor

研究点 (1)

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