NCT02192775已完成2 期
A Phase II Trial of Oncolytic Virotherapy by Systemic Administration of Edmonston Strain of Measles Virus, Genetically Engineered to Express NIS, With Cyclophosphamide, in Patients With Recurrent of Refractory Multiple Myeloma
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
- 2
- 试验地点
- 1
- 主要终点
- The Effectiveness of MV-NIS Therapy as Measured by the International Myeloma Working Group (IMWG) Guidelines
研究概览
简要总结
The purpose of this study is to determine the clinical efficacy of MV-NIS (measles virus-sodium iodide symporter) therapy for people with relapsed/refractory myeloma when given with cyclophosphamide
详细描述
The drug used in this trial is a modified version of the measles virus used to vaccinate children. The virus has been altered by having an extra gene (piece of DNA) added to it to allow a protein called NIS to be inserted into it. NIS is normally found in the thyroid gland ( a small gland in the neck) and helps the body concentrate iodine. Having this additional gene will make it possible to track where the virus goes in the body.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed patients must have a confirmed MM diagnosis with high-risk disease as defined by GEP70 risk score ≥ 0.66 or GEP80 gene score of ≥ 2.48 or metaphase cytogenetic abnormalities or LDH ≥ 360 U/L due to MM (Rule out hemolysis, infection and contact PI for clarification if any doubt). Patients must have relapsed after auto-PBSCT followed by further chemotherapy
- •≥2 months must have elapsed after the last peripheral blood stem cell transplant prior to enrollment
- •Zubrod ≤ 2, unless solely due to symptoms of MM-related (bone) disease
- •Patients must have a platelet count of ≥ 20,000/µL within 45 days of registration, unless lower levels are explained by extensive BM plasmacytosis or extensive prior therapy
- •Patients must be at least 18 years of age and not older than 75 years of age at the time of registration
- •Participants must have preserved renal function as defined by a serum creatinine level of ≤ 3 mg/dL within 45 days of registration
- •Participants must have an ejection fraction by ECHO or MUGA scan ≥ 40% within 45 days prior to registration
- •Patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (FEV1, etc) and diffusion capacity (DLCO) > 50% of predicted within 45 days prior to registration. If the patient is unable to complete pulmonary function tests due to MM related pain or condition, exception may be granted
- •Patients must have signed an IRB-approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization form
- •Patients must have anti-MV IgG titer of ≤ 0.5U/mL (Mayo clinic assay). Mayo Clinic will also assay the patients' IgM titer and perform a neutralizing antibody plaque-assay to determine recent MV exposure and the ability of the patients' circulating antibodies to inhibit MV propagation on Vero cells, respectively. While these tests are additional indicators of patient eligibility, final enrollment decision will be determined by IgG levels
排除标准
- •Patients may not be positive for the Human Immunodeficiency Virus (HIV)
- •History of poorly controlled hypertension, diabetes mellitus, or any other serious medical illness or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol or could be considered to be an exclusion criterion deemed by the PI
- •Patients must not have prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has not received treatment for one year prior to enrollment. Other cancers will only be acceptable if the patient's life expectancy exceeds three years as determined by the PI
- •Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy test documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
- •Exposure to household contacts ≤ 15 months old or household contact with known immunodeficiency
研究组 & 干预措施
MV-NIS + Cyclophosphamide
Experimental
干预措施: MV-NIS (Drug)
结局指标
主要结局
The Effectiveness of MV-NIS Therapy as Measured by the International Myeloma Working Group (IMWG) Guidelines
时间窗: 1 year
The primary objective of this study is to assess the effectiveness of MV-NIS therapy for people with relapsed/refractory myeloma when given with cyclophosphamide
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Trial of Intravesical Measles Virotherapy in Patients With Bladder Cancer Who Are Undergoing Radical CystectomyUrothelial CarcinomaNCT03171493Vyriad, Inc.8
已完成
1 期
Intrapleural Measles Virus Therapy in Patients With Malignant Pleural MesotheliomaRecurrent Malignant MesotheliomaStage IA Malignant MesotheliomaStage IB Malignant MesotheliomaStage II Malignant MesotheliomaStage III Malignant MesotheliomaStage IV Malignant MesotheliomaNCT01503177Mayo Clinic15
进行中（未招募）
1 期
MV-NIS Infected Mesenchymal Stem Cells in Treating Recurrent Ovarian, Primary Peritoneal or Fallopian Tube CancerFallopian Tube Clear Cell AdenocarcinomaFallopian Tube Endometrioid AdenocarcinomaFallopian Tube Mucinous AdenocarcinomaFallopian Tube Serous AdenocarcinomaFallopian Tube Transitional Cell CarcinomaFallopian Tube Undifferentiated CarcinomaMalignant Ovarian Brenner TumorOvarian Clear Cell AdenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian Mucinous AdenocarcinomaOvarian Seromucinous CarcinomaOvarian Serous AdenocarcinomaOvarian Transitional Cell CarcinomaOvarian Undifferentiated CarcinomaPrimary Peritoneal Serous AdenocarcinomaRecurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Primary Peritoneal CarcinomaNCT02068794Mayo Clinic34
招募中
2 期
Oncolytic Virotherapy Combined With Tislelizumab Plus Lenvatinib in Patients With Advanced Biliary Tract Cancer (OPTIONS-05)Advanced Biliary Tract CancerNCT05823987Fudan University25
招募中
1 期
A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast CancerInvasive Breast CarcinomaMetastatic Breast AdenocarcinomaRecurrent Breast CarcinomaNCT04521764Mayo Clinic54