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

Dr Reddys Laboratories Limited0 个研究点目标入组 84 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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

•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

发起方