Autologous Stem Cell Transplantation With Nivolumab in Patients With Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Overall response
研究概览
简要总结
This is an open-label, single center trial of Autologous Stem Cell Transplantation (ASCT) with nivolumab in multiple myeloma patients to determine the efficacy and safety of ASCT and PD1 inhibitor combination.
For this purpose, 30 multiple myeloma patients, who have received induction therapy and have achieved a partial response (PR), stable disease (SD) or progression, and thus have unfavorable prognosis, will be treated with nivolumab administered iv at a dose of 100 mg on days 3 before and 17 after high-dose melphalan with autologous stem cell transplantation.
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
- •Subjects with MM (Multiple Myeloma)
- •Partial response, stable disease or progression after induction therapy (including ASCT)
- •Measurable disease
- •Successful peripheral blood stem cell collection with G-CSF
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
- •Signed informed consent
- •Patients after first-line induction therapy
排除标准
- •Another malignancy requiring treatment at the time of inclusion
- •History of interstitial lung disease or pneumonitis
- •Patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure NYHA Class III or IV, myocardial infarction within 6 months, and poorly controlled hypertension) which, in the opinion of the investigator could compromise participation in the study
- •Uncontrolled bacterial or fungal infection at the time of enrollment
- •Pregnancy
- •Somatic or psychiatric disorder making the patient unable to sign informed consent
- •Active or prior documented autoimmune disease requiring systemic treatment
- •Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA4 therapy
研究组 & 干预措施
Mel+Nivo
Autologous Stem Cell Transplant Drug: Melphalan 140-200 mg/m^2, Nivolumab100 mg iv days -3, +17
干预措施: Melphalan (Drug)
Mel+Nivo
Autologous Stem Cell Transplant Drug: Melphalan 140-200 mg/m^2, Nivolumab100 mg iv days -3, +17
干预措施: Nivolumab (Drug)
Mel+Nivo
Autologous Stem Cell Transplant Drug: Melphalan 140-200 mg/m^2, Nivolumab100 mg iv days -3, +17
干预措施: Autologous Stem Cell Transplantation (Procedure)
结局指标
主要结局
Overall response
时间窗: 3 months
Includes complete response, very good partial response, and partial response (based on IMWG criteria)
次要结局
- Progression free survival (PFS)(12 months)
- Overall Survival (OS)(24 months)
- Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03(12 months)
研究者
Ivan S Moiseev
R.M.Gorbacheva memorial institute vice director for research
St. Petersburg State Pavlov Medical University