CTRI/2013/12/004235暂停未知
A RANDOMIZED, OPEN LABEL, TWO TREATMENT, TWO PERIOD, TWO SEQUENCE,SINGLE DOSE, CROSSOVER, BIOEQUIVALENCE STUDY OF BORTEZOMIB FOR INJECTION,3.5 MG/VIAL (1.3 MG/M2 DOSE) OF SUN PHARMACEUTICAL INDUSTRIES LIMITED, INDIA,AND VELCADE (BORTEZOMIB) FOR INJECTION 3.5 MG/VIAL (1.3 MG/M2 DOSE) OF MILLENNIUM PHARMACEUTICALS, INC. IN PATIENTS WITH MULTIPLE MYELOMA,UNDER FED (NORMAL BREAKFAST) CONDITIONS.
试验速览
- 阶段
- 未知
- 状态
- 暂停
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •Subjects meeting all of the following criteria will be considered for enrollment in the study:
- •i. Subject willingness to adhere to protocol requirements and able to give inform consent.
- •ii. Patients with a diagnosis of relapsed multiple myeloma requiring bortezomib therapy. (For whom bortezomib therapy need to be initiated for the first time)
- •iii. Patients at least 18-years of age or older.
- •iv. Subjects who have no evidence of underlying disease which in the judgment of the investigator would not make the subject inappropriate for getting enrolled in the study (except multiple myeloma) during screening medical history and whose physical examination are performed within 7 days prior to Commencement of the study.
- •v. Subjects with performance >=70% Karnofsky performance status scale
- •vi.Subjects whose screening laboratory values are within normal limits or considered by the
- •Investigator/sub-Investigator to be of no clinical significance obtained <= one week prior to enrollment.
- •VII. Female Subjects
- •of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm intrauterine device (IUD), or abstinence, oral or depot contraceptives for at least 2 months prior to study entry.
- •Postmenopausal for at least 1 year.
- •surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been
- •Performed on the subject).
排除标准
- •1. History or presence of significant:
- •i. Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Bortezomib,boron, or mannitol or Tromethamine and/or any related compounds etc.
- •Â ii. Cardiac disease, equal to or greater then Grade 2 neuropathy, Grade 1 neuropathy with pain,
- •pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic,
- •musculoskeletal, neurological or psychiatric disease, proven amyloidosis, secondary
- •malignancy, plasma cell leukemia or polyneuropathy, organomegaly, M-protein, Skin
- •changes (POEMS) syndrome.
- •Â iii. Subjects taking concurrent medications at entry that may act as inhibitors/ inducers of
- •iv. Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug
- •Within past one year.
- •v. Patients who are transfusion dependent or had received extensive radiation therapy (per
- •investigatorâ??s discretion), systemic chemotherapy, other antineoplastic therapy or other investigational agent within 4 weeks, or thalidomide with in 2weeks of enrollment.
- •vi. Subject deemed uncooperative or noncompliant.
- •vii. Smoking (>= 10 cigarettes/day) or consumption of tobacco products (>= 4 chews/day).
- •viii. Difficulties in coming for follow up.
- •ix. Clinically significant illness (except multiple myeloma) within 4 weeks before the start of the
- •x. Female subject who is pregnant, lactating or likely to become pregnant or have a positive
- •Pregnancy test at screening and prior to check-in of each period.
- •xi. Positive result to HIV, HCV, RPR and HBsAg.
- •xii. Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Griseofulvin) In the previous 30 days before day 1 of this study and during the study.
- •xiii. Abnormal 12 lead ECG, X-ray and 2D-Echocardiography finding.
- •2. Donation of blood in the previous 90 days before day 1 of this study.
- •3. Participation in another clinical trial within the preceding 90 days of study starts and receiving anticancer
- •Chemotherapy outside of a clinical trial within the preceding 30 days of study start.
- •4. Subjects who have:
- •i. Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg.
- •ii. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations
- •(2 - 4 mm Hg) at check-in may be acceptable at the discretion of the investigator.
- •iii. Pulse rate below 60/min. or above 100/min.
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