ZIO-101 在晚期多发性骨髓瘤中的 II 期试验：方案 SGL2001b
The study of safety of a new organic arsenic compound in the treatment of advanced multiple myeloma
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Arizona
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Glendale、Arizona、美国
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California
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Santa Barbara、California、美国
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Santa Rosa、California、美国
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West Hollywood、California、美国
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Maryland
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Bethesda、Maryland、美国
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New York
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Buffalo、New York、美国
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North Carolina
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Charlotte、North Carolina、美国
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South Dakota
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Sioux Falls、South Dakota、美国
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
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Subjects with a confirmed diagnosis of active multiple myeloma with measurable protein criteria present to evaluate response. Measurable disease is defined as having at least one of the following criteria within 28 days prior to registration:
- Serum M-protein level > 0.5 gm/dl (10.0 g/L) measured by serum protein electrophoresis.
- Urinary M-protein excretion > 0.2 g/24 hours by urine electrophoresis.
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Subjects must have relapsed or resistant disease, defined as either relapsing or is resistant after > 2 lines of prior therapy for myeloma. A minimum of 42 days must have elapsed since prior autologous or allogeneic transplant;
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Informed consent compliant with ZIOPHARM policies and approved by the Human Investigation Review Committee with jurisdiction over the site;
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ECOG performance score ≤ 1;
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No chemotherapy, bortezomib, lenalidomide, thalidomide, arsenic trioxide, radiation therapy or immune therapy for ≥ 3 w and recovered from all treatment associated toxicities prior to registration; 5a. Patients may not receive more than the equivalent of 10 mg of prednisone per day for 2 weeks prior to registration.
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Age ≥ 18;
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Granulocytes ≥ 1.0 x 109/L; platelets ≥ 50 x 109/L;
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Bilirubin ≤ 2.0 mg/dL; AST and ALT ≤ 2 x ULN;
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Creatinine ≤ 3 X ULN.
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No investigational agents within 28 days of study entry.
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Males who agree to use a double-barrier method of birth control, (Double barrier method is defined as: a condom and either a diaphragm/cervical cap or an IUD).
Exclusion Criteria
- NYHA functional class ≥ 3, myocardial infarction ≤ 6 mo or uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; QTc ≥ 450msec; AV-block ≥ grade-2 or LBBB;
- Women of childbearing potential. (Non-childbearing potential is defined as: surgical sterilization or 2 years post-menopausal)
- Active infection requiring antibiotics;
- Allergy to ZIO-101 or its excipients;
- Baseline confusion or dementia, defined as grade > 2 CTCAE Version 3.0;
- Significant neurotoxicityneuropathology, defined as grade > 2 neurotoxicity neuropathology per CTCAE Version 3.0;
- Prior seizures ≥ grade-3 in CTC v.3 criteria.
- Prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：单臂
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420 mg/m2 of Darinaparsin given twice weekly for three weeks, followed by one week of rest for up to six months
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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反应速度
大体时间：6个月
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6个月
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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生存（总体和无进展）
大体时间：6个月
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6个月
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毒性
大体时间：6个月
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6个月
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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