A Multicentre, Open label, Balanced, Randomized, Two-treatment, Two-period, Single dose,Crossover, Bioequivalence study of Bortezomib for Injection 3.5 mg/vial of Dr. Reddy’sLaboratories Limited, India and VELCADE® (bortezomib) for Injection 3.5 mg/vial (Distributedby: Millennium Pharmaceuticals, Inc., 40 Landsdowne Street, Cambridge, MA 02139) in previouslyuntreated Multiple Myeloma and/or Relapsed/Refractory Multiple Myeloma patients.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 64
- 试验地点
- 19
- 主要终点
- To assess the Bioequivalence between Bortezomib for Injection 3.5 mg/vial of Dr. Reddy’s Laboratories Limited, India and VELCADE® (bortezomib) for Injection 3.5 mg/vial (Distributed by: Millennium Pharmaceuticals, Inc., 40 Landsdowne Street, Cambridge, MA 02139) in previously untreated Multiple Myeloma and/or Relapsed/Refractory Multiple Myeloma patients.
研究概览
简要总结
This is a Multicentre, Open label, Balanced, Randomized, Two-Treatement, Two-Period, Single dose, Crossover bioequivalence of the Test Product (Bortezomib for Injection 3.5 mg/vial of Dr. Reddy’s Laboratories Limited, India) relative to that of Reference Product (VELCADE® (bortezomib) for Injection 3.5 mg/vial (Distributed by: Millennium Pharmaceuticals, Inc., 40 Landsdowne Street, Cambridge, MA 02139)) in previously untreated Multiple Myeloma and/or Relapsed/Refractory Multiple Myeloma patients. Reconstitution Procedure: Add 1.4 mL of sterile 0.9% sodium chloride solution to theBortezomib powder contained in the vial. The final reconstituted concentration will be 2.5 mg/mL. The reconstituted product should be a clear and colourless solution free of particulate matter. Reconstitution will be done within 1 hr prior to dosing. Bortezomib 3.5 mg/vial reconstituted solution (with final Bortezomib concentration of 2.5 mg/mL) will be administered subcutaneously in abdomen (right or left). The solution should be injected subcutaneously, at a 45-90° angle. A total of 32 blood samples each of 4 mL will be collected from each patient for PK assessment and 20 samples, each of 3mL for PD assessment during the study. Venous blood samples will be withdrawn for each patient on Day 32 (Period 1) and Day 53 (Period 2) for PK and PD assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with histopathologically/cytologically confirmed multiple myeloma.
- •2.Adult patients with previously untreated Multiple Myeloma or Relapsed/Refractory Multiple Myeloma for whom Bortezomib is considered as suitable treatment as per the Principal Investigator judgement.
- •3.Patient with an ECOG performance status of 0-
- •4.Patient must have an adequate bone marrow, renal and hepatic function 5.Life expectancy should be ≥3 months.
排除标准
- •1.Known hypersensitivity to Bortezomib, Boron, Tromethamine, Citric acid or to any of the excipients, Melphalan and Prednisone (for previously untreated Multiple Myeloma patients) 2.If the patient had undergone prior surgery, radiation, chemotherapy, or other anticancer therapy within 4 weeks (28 days) prior to the start of Bortezomib therapyin the study 3.Patients with positive human immunodeficiency virus (HIV) infection.
- •4.A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
- •5.Use of any recreational drugs or history of drug addiction.
- •6.A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds (ms)).
- •7.A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) 8.The use of concomitant medications that prolong the QT/QTc interval 9.Acute diffuse infiltrative pulmonary and pericardial disease.
- •10.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
- •11.Patients who are receiving strong CYP3A4/CYP2C19/CYP1A2 – inhibitors and/or inducers and in whom these drugs are unable to be restricted for the entire study period.
- •12.Peripheral Neuropathy Grade 1 with pain or Grade 2 and above.
- •13.End Stage Renal Disease.
结局指标
主要结局
To assess the Bioequivalence between Bortezomib for Injection 3.5 mg/vial of Dr. Reddy’s Laboratories Limited, India and VELCADE® (bortezomib) for Injection 3.5 mg/vial (Distributed by: Millennium Pharmaceuticals, Inc., 40 Landsdowne Street, Cambridge, MA 02139) in previously untreated Multiple Myeloma and/or Relapsed/Refractory Multiple Myeloma patients.
时间窗: PK assessment Pre-dose (0.000) and at 0.083, 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.500, 3.000,6.000, 9.000, 12.000, 24.000, 48.000 and 72.000 hrs post dose. | PD assessment:Pre-dose (0.000) and 0.333, 0.500, 1.000, 2.000, 4.000, 12.000, 24.000, 48.000 and 72.000 hrs post-dose.
次要结局
- 1.To monitor the safety and tolerability of the patients exposed to the Investigational(Medicinal Product.)