To monitor the safety and to assess bioequivalence of Bortezomib for injection, 3.5 mg/vial (1.3 mg/m2 dose) of Sun Pharmaceutical Industries Limited and Velcade (Bortezomib) for injection 3.5 mg/vial (1.3 mg/m2 dose) of Millennium Pharmaceuticals, in multiple myeloma patients, under fed conditions.
- Conditions
- Health Condition 1: null- Cancer(relapsed multiple myeloma)
- Registration Number
- CTRI/2013/12/004235
- Lead Sponsor
- Sun Pharmaceutical Industries Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 40
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.
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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).
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.
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 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.
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 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.
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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.
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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.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method /ATimepoint: N/A