NCT00241371终止2 期
A Phase II Study of Clofarabine in Patients With Relapsed or Refractory Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Overall response rate (CR+PR)
研究概览
简要总结
To determine the overall response rate (CR+PR) of patients with relapsed or refractory multiple myeloma treated with clofarabine.
详细描述
To determine the time to response, duration of response, and time to progression of patients treated with clofarabine.
To determine the safety and tolerability of clofarabine in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple myeloma diagnosed by standard criteria.
- •Measurable levels of monoclonal protein in serum (>= 0.5 g/dL) or urine (>= 0.2 g/24 hr).
- •At least 1 prior therapies for multiple myeloma with documented evidence of progression on the most recent treatment.
- •Age 18 years or older.
- •ECOG performance status <=
- •Acceptable organ and marrow function as defined below:
- •Hemoglobin >= 8 gm/dL
- •Absolute neutrophil count >= 1,000/mm3
- •Platelets >= 50,000/mm3
- •Total bilirubin <= 2.5 X institutional upper limit of normal
- •AST, ALT <= 2.5 X institutional upper limit of normal
- •Creatinine 1.5 x institutional upper limit of normal
- •Normal cardiac function as determined by standard institutional methods
- •Women of child bearing potential must agree to use adequate contraception prior to study entry and for the duration of study.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Receiving any other investigational agents.
- •Receiving concurrent steroids with a dose equivalent of prednisone of >= 150 mg/month.
- •Pregnant or nursing.
- •Active systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
- •Severe concurrent disease, including severe insulin-dependent diabetes, uncontrolled hypertension, transient ischemic attacks, uncontrolled symptomatic coronary artery disease, or symptomatic CNS involvement or psychiatric illness/social situations that would limit compliance with study requirements.
- •History of other malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast unless the subject has been off treatment and free from disease for >= 3 years.
研究组 & 干预措施
Clofarabine
Experimental
4 mg/m2 IV over 1 hour on days 1-5 of each 28 day cycle.
干预措施: Clofarabine (Drug)
结局指标
主要结局
Overall response rate (CR+PR)
时间窗: Every 3 months
次要结局
- Safety and tolerability of clofarabine(30 days after last treatment)
- Duration of response(Every 3 months)
- Time to response(Every 3 months)
- Time to progression(Every 3 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Phase II Study of Clofarabine in Patients With Aggressive Non-Hodgkin's LymphomaNon-Hodgkin's LymphomaNCT00201669Ohio State University Comprehensive Cancer Center6
撤回
2 期
Clofarabine for Langerhans in PediLangerhans Cell HistiocytosisNCT01796405Dana-Farber Cancer Institute
已完成
1 期
Carfilzomib + High Dose Melphalan as Preparative Regimen for Autologous Hematopoietic Stem Cell TransplantationMultiple MyelomaNCT01690143University of Alabama at Birmingham45
已完成
1 期
A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple MyelomaPlasma Cell LeukemiaMultiple MyelomaNCT00821249Pfizer55
终止
2 期
Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone as Salvage Therapy in Relapsed/Refractory Multiple MyelomaRelapsed/Refractory Multiple MyelomaNCT03590652University of California, San Diego23