CTRI/2013/12/004202尚未招募1 期
An open label, balanced, randomized, two-treatment, single dose, parallel, two stage adaptive group sequential bioequivalence study of Bortezomib 3.5 mg powder for solution for Injection of Dr. Reddyâ??s Laboratories Limited, India and VELCADE 3.5mg powder for solution for injection of JANSSEN-CILAG INTERNATIONAL NV, Belgium in Relapsed/Refractory Multiple Myeloma patients under fasting conditions - NA
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patient and /or LAR or impartial witness able to give written informed consent for participation in the trial
- •2.Patients with histopathologically/cytologically confirmed multiple myeloma
- •3.Patient with an ECOG performance status of 0-2
- •4.Patient must have an adequate bone marrow, renal and hepatic function
- •5.Patient should be able to comply with study procedures in the opinion of the investigator
- •6.Life expectancy should be >3 months
排除标准
- •1.Known hyper sensitivity to bortezomib, boron or to any of the excipients
- •2.If the patient had undergone prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks (28 days) prior to dosing in the study
- •3.Patients with known human immunodeficiency virus (HIV) infection.
- •4.A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies
- •5.Any other condition or abnormal baseline findings that, in the investigatorâ??s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study
- •6.The receipt of an investigational medicinal product within a period of 30 days prior to the first dose of Investigational Medicinal Product for the current study
- •7.Patient with a history of difficulty in donating blood or difficulty in accessibility of veins
- •8.Acute diffuse infiltrative pulmonary and pericardial disease
研究者
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