CTRI/2020/06/025971招募中1 期
An Open label, Multi-Centre, Randomized, Two-treatment, Multi dose, Parallel, Comparative Bioavailability Study of Bortezomib Injection 3.5 mg/0.2 ml and VELCADE 3.5 mg powder for solution for injection at a dose of 1.3 mg/m2 in Multiple Myeloma patients.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 37
- 主要终点
- To compare the Cmax and AUC0-Ï„ between Test and Reference Products on Day 1 and Day 15.
研究概览
简要总结
This is an An open label, Multi-Centre, Randomized, Two-treatment, Multi dose, Parallel, Comparative Bioavailability Study of Test Product (Bortezomib Injection 3.5 mg/0.2 ml of Shilpa Medicare Ltd, India) and Reference Product (VELCADE 3.5 mg powder for solution for injection at a dose of 1.3 mg/m2 Distributed and Marketed by Millennium Pharmaceuticals, Inc., 40 Landsdowne Street, Cambridge, MA 02139) in previously untreated Multiple Myeloma and/or under treatment with Bortezomib or Relapsed Multiple Myeloma patients.
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
- •Patient with histopathologically/ cytologically confirmed multiple myeloma.
- •Adult multiple myeloma patients weighing between 45 to 80 kg (both inclusive) who are naïve and/or under treatment with Bortezomib or relapsed multiple myeloma (who have previously responded to treatment with Bortezomib either alone or in combination and who have relapsed at least 6 months after the prior therapy).
- •Patient with ECOG (Eastern Co-operative Oncology Group) performance status ≤
- •Patient with performance ≥70% Karnofsky performance status scale.
- •Patient must have adequate bone marrow (Hemoglobin levels ≥ 8.0 g/dL, ANC ≥1500/mm3 and platelet count ≥ 1,00,000/mm3) prior to enrollment.
- •Patient must have adequate renal function (Serum creatinine ≤ 1.5 times of ULN).
- •About 10% of Renal impaired patients will be enrolled who have Cockcroft-Gault creatinine clearance ≥ 30 ml/min with an upper limit of 89 ml/min.
- •Patient must have adequate hepatic function (Serum bilirubin ≤ 1.5 times of ULN and AST/ALT ≤ 2.0 times of ULN).
- •Subject who have no evidence of underlying disease which in the judgement of the investigator would not make the subject inappropriate for getting enrolled in the study (except multiple myeloma), during screening.
- •Patient and /or LAR or impartial witness able to give written informed consent for participation in the trial.
- •Patient with life expectancy of at least four months.
- •In the opinion of the investigator, patient should be able to comply with study procedures.
- •Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal (females who have had a natural menopause for at least 24 consecutive months), must agree to use two effective methods of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 60 days after the last dose of study drug.
- •Cessation of birth control after this point should be discussed with a responsible physician.
- •In case of male patients: Male patients must agree to practice complete abstinence or agree to use a condom during sexual contact with a female even if they have had a successful vasectomy.
- •It is investigator’s responsibility to ensure that above points regarding an effective method of avoiding pregnancy are discussed with patient in detail and patient agreed for this and it is documented in source document.
- •The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol.
排除标准
- •Known hypersensitivity to Bortezomib or to any of the excipients, Cyclophosphamide and Dexamethasone.
- •If the patient had undergone prior surgery, chemotherapy, or other anti- cancer therapy within 4 weeks (28 days), thalidomide and/or lenalidomide within 2 weeks prior to dosing in the study.
- •Patient with known human immunodeficiency virus (HIV) infection.
- •A positive hepatitis screen including HBSAg and HCV antibodies.
- •Use of any recreational drugs or history of drug addiction.
- •A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds (ms)) or history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) or use of concomitant medications that prolong the QT/QTc interval.
- •History of venous thromboembolism or disease that aggravate risk for thromboembolism.
- •Patient taking concurrent medications at entry that may act as inhibitors/inducers of CYP3A4 CYP2C19 and CYP1A
- •Patient with cardiac disease known and clinically significant grade 2 neuropathy, pulmonary, hepatic, gastrointestinal, endocrine, immunologic, dermatological, musculo-skeletal, psychiatric, neurological, proven amyloidosis and secondary malignancy.
- •Patient with a history of difficulty in donating blood or difficulty in accessibility of veins.
- •Patient participated in any drug intervention study and donated blood within 90 days prior to the current study.
- •Female patients with pregnancy or breast-feeding.
- •Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study treatment.
结局指标
主要结局
To compare the Cmax and AUC0-Ï„ between Test and Reference Products on Day 1 and Day 15.
时间窗: During the entire duration of the trial
次要结局
- a) To assess the injection site reactions (local tolerability) of the investigational drug product(s).(b) To monitor adverse events and ensure the safety of subjects.)
研究者
研究点 (37)
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