Health Condition 1: null- Cancer(relapsed multiple myeloma)
Conditions
Interventions
Intervention1: Bortezomib for injection,3.5 mg/vial (1.3 mg/m2 dose)of Sun Pharmaceutical Industries Limited, India.
Dose:1.3 mg/m2: Route of Administration: Injection,preferably near to ante-cubital
Sponsors
Sun Pharmaceutical Industries Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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  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. OR • Postmenopausal for at least 1 year. OR • surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been Performed on the subject).
Exclusion criteria
Exclusion criteria: 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 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 Â iii. Subjects taking concurrent medications at entry that may act as inhibitors/ inducers of CYP3A4. 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. Â 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 study. 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. Â 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the bioequivalence after single dose administration under fed (Normal breakfast) conditions.Timepoint: To assess the bioequivalence after single dose administration under fed (Normal breakfast) conditions. | — |
Secondary
| Measure | Time frame |
|---|---|
| N/ATimepoint: N/A | — |
Countries
India
Contacts
Public ContactDr Aman Khanna MD
Sun Pharmaceutical Industries Ltd.
Outcome results
None listed