NCT01250808Available不适用
Technology Platform and System Construction of Clinical Evaluation Studies on New Drugs of Hematological Malignancy
Peking University1 个研究点 分布在 1 个国家开始时间: 2010年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Available
- 发起方
- 试验地点
- 1
研究概览
简要总结
Multiple Myeloma (MM) is the second diagnosed malignancy of hematological malignancies. The previous study pointed out that the dosage and course of Bortezomib including the dose of concomitant drugs used to treatment MM patients did not get the preferred treatment program, so we are going to determine the optimal doses and course of Bortezomib through the prospective, multicenter clinical trial and evaluate the efficiency and safety of different program.
研究设计
- 研究类型
- Expanded Access
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
- •Obtain informed consent form (ICF) signed by patients or its relative.
- •Patients newly diagnosed multiple myeloma (MM). (Not include patients with multiple solitary extramedullary plasmacytoma and those atⅠstage of Durie-Salmon staging system)
- •Measurable serum protein:
- •IgG type of MM: serum M-protein≥ 1.0g/dl or urine M-protein≥ 200mg/24h. IgA type of MM: serum M-protein≥0.5g/dl or urine M-protein≥200mg/24h. IgM type of MM: (IgM M-protein and osteolytic lesion showed in X-ray):serum protein≥ 1.0g/dl or urine M-protein≥ 200mg/24h. IgD type of MM: serum M-protein≥0.05g/dl or urine M-protein≥200mg/24h. Light chain type of MM: serum M-protein≥ 1.0g/dl or urine M-protein≥ 200mg/24h.
- •Physical score 0~2 grade(WHO standard), and able to comply with the visit time and protocol requirements.
排除标准
- •Diagnosed with relapsed multiple myeloma.
- •Any serious diseases which may lead patients suffer from unaccepted risk.
- •Female patients who is pregnant or breast-feeding.
- •Histories of other malignant tumors other than MM, except those patients whose disease have been cured for at least 3 years. Exception: basal-cell carcinoma, squamous cell carcinoma, carcinoma in situ of uterine cervix, breast carcinoma in situ,occasionally prostatic cancer histological discovery(at stage T1a or T1B defined as TNM classification).
- •Not be able to understand or comply with the investigate protocol.
- •Patients with grade 2 or higher peripheral neuropathy before treatment.
研究者
研究点 (1)
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