NCT01105403已完成2 期
A Phase IIa, Proof of Concept Study is to Determine the Degree of Mobilisation of CD34+ Cells Following Administration of POL6326 in Patients With Multiple Myeloma
Polyphor Ltd.1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2009年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- To assess the ability of POL6326 to mobilise CD34+ hematopoietic stem cells in patients with primary multiple myeloma
研究概览
简要总结
The purpose of this study is to determine whether POL6326 is safe and clinically active to mobilize hematopoietic stem cells followed by 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
- •Have multiple myeloma in Stage II or III, according to the criteria of Durie and Salmon.
- •Male or female between 18 and 70 years of age, inclusive. Male and females capable of reproduction must agree to use adequate contraceptive measures (e.g. condom, intrauterine device, oral contraceptive) until 3 months after termination of treatment.
- •Measurable disease, defined by one of the following:
- •Serum M protein ≥1.0 g/dL by protein electrophoresis
- •Quantifiable immunoglobulin levels and/or
- •urinary M protein excretion ≥200 mg/24 hours.
- •All patients have undergone 3 cycles of chemotherapy, with the last dose of chemotherapy given 3 to 8 weeks before study entry.
- •Eastern Cooperative Oncology Group (ECOG) performance status of
- •Life expectancy of >6 months.
- •Have given their written informed consent to participate in the study
排除标准
- •Have non-secretory myeloma and/or plasma cell leukaemia.
- •History of other malignancies during the past 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma, or localised prostate carcinoma.
- •Any other clinically significant medical conditions.
- •History of cardiac disease NHYA classification ≥
- •Insufficient bone marrow, liver and renal function as assessed by the following clinical laboratory evaluations:
- •Haemoglobin <9.0 g/L. Absolute neutrophil count <1500/µL. Platelet count <50000/µL. Total bilirubin >1.5 x upper limit of normal (ULN). Alanine aminotransferase (ALT) and alkaline phosphatase (AP) >2.5 x ULN. Amylase and lipase >1.5 x ULN. Serum creatinine >2.0 x ULN. Prothrombin time (PT) and activated partial thrombo-plastin time (aPTT) >1.5 x ULN.
- •Pregnant or lactating female patients.
- •Known history of HIV infection or chronic hepatitis B or C infection.
- •Receipt of immunotherapy, radiation therapy, or any investigational drug within 30 days of study drug administration.
- •Prior radiotherapy to more than 3 vertebrae.
- •Active serious bacterial or fungal infections; >grade 3 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
- •Receipt of haematopoietic cytokines within 10 days of study drug administration.
研究组 & 干预措施
CD34+ mobilisation for transplantation
Experimental
干预措施: POL6326 (Drug)
结局指标
主要结局
To assess the ability of POL6326 to mobilise CD34+ hematopoietic stem cells in patients with primary multiple myeloma
时间窗: Up to four days
Number of patients achieving the minimal number of CD34+ cells (≥2 x 10 mill/kg BW) collected during one to four cycles of apheresis which are considered necessary and safe to proceed with autotransplantation Number of apheresis cycles required to obtain the minimal number of CD34+ cells necessary for autotransplantation (≥2 x 10 mill/kg BW)
次要结局
- To evaluate the safety and pharmacokinetics of POL6326 in patients with multiple myeloma(2 months)
- To determine the efficacy of POL6326 in reconstitution of immune system after transplantation(1 year)
研究者
研究点 (1)
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