NCT01861340已完成早期 1 期
Pilot Study of Lenalidomide and Dexamethasone in Combination With MEDI-551 in Previously Untreated Multiple Myeloma.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The effect of Lenalidomide, dexamethasone and Medi-551 on multiple myeloma cancer stem cells (CSCs).
研究概览
简要总结
This research study is being done to see if combining the investigational chemotherapy drug, MEDI-551 with the known anti-myeloma drugs, Lenalidomide and Dexamethasone will reduce your myeloma cancer stem cells.
详细描述
To explore the effect of Lenalidomide, dexamethasone and Medi-551 on multiple myeloma cancer stem cells (CSCs). Myeloma CSCs will be assessed by a clonogenic assay from the bone marrow and flow cytometry from peripheral blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 100 years at the time screening
- •Symptomatic, previously untreated (with exception of corticosteroids) secretory myeloma
- •Written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations
- •Patient must agree to take Lenalidomide with low dose dexamethasone as their initial therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
- •Life expectancy of >6 months
- •Serum creatinine ≤ 2
- •Platelets ≥ 50,000
- •Total bilirubin ≤ 2 x upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 x ULN
- •Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin)
排除标准
- •Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of patient safety or study results.
- •Concurrent enrollment in another clinical study, except for non-interventional, observational studies.
- •Any chemotherapy, immunotherapy, biologic, investigational, for treatment of multiple myeloma other than Lenalidomide and dexamethasone.
- •Previous monoclonal antibody (mAb) or other treatment specifically directed against cluster of differentiation antigen 19 (CD19).
- •History of serious allergy or reaction to any component of the MEDI-551 formulation that would prevent administration.
- •Previous systemic cancer therapy for myeloma.
- •Any active secondary malignancy.
- •Human immunodeficiency virus (HIV) positive serology or acquired immune deficiency syndrome.
- •Active hepatitis B as defined by seropositivity for hepatitis B surface antigen. Or patients with positive hepatitis B core antibody titers.
- •Patients with hepatitis C antibody will be eligible provided that they do not have elevated liver transaminases or other evidence of active hepatitis.
- •Documented current central nervous system involvement by multiple myeloma.
- •Previous medical history or evidence of an intercurrent illness that may, in the opinion of the investigator, compromise the safety of the patient in the study.
- •Diagnosis of plasma cell leukemia
- •Diagnosis of POEMS syndrome
- •Diagnosis of Amyloidosis
- •Diagnosis of non-secretory myeloma
研究组 & 干预措施
Lenalidomide, Dexamethasone, and MEDI-551
Experimental
Eligible patients will receive Lenalidomide and dexamethasone as per standard of care guidelines for 2 cycles. Patients with a clinical response to lenalidomide and dexamethasone after 2 cycles will proceed to get MEDI-551 for 2 cycles. MEDI-551 will be dosed at 4mg/kg IV on days 1 and 8 of cycle 3 and 4mg/kg IV on day 1 of cycle 4.
干预措施: Lenalidomide, Dexamethasone, and MEDI-551 (Drug)
结局指标
主要结局
The effect of Lenalidomide, dexamethasone and Medi-551 on multiple myeloma cancer stem cells (CSCs).
时间窗: 16 weeks
次要结局
- The safety of Medi-551 when combined with Lenalidomide and dexamethasone.(28 weeks)
研究者
研究点 (1)
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