Bioavailability study of Bortezomib for Injection 3.5 mg/vial in patients with Multiple Myeloma
- Conditions
- Health Condition 1: C900- Multiple myeloma
- Registration Number
- CTRI/2019/03/018107
- Lead Sponsor
- Shilpa Medicare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
1Patients with histopathologically/cytologically confirmed multiple myeloma.
2Adult multiple myeloma patients (weighing between 50 to 80 kg) 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).
3Patients with ECOG (Eastern Co-operative Oncology Group) performance status 0, 1 or 2 (Refer Appendix - I).
4Patient with performance >=70% Karnofsky performance status scale (Refer Appendix - II).
5Patient must have adequate bone marrow (Hemoglobin levels >= 8.0 g/dL, ANC >=1500/mm3 and platelet count >= 1,00,000/mm3) prior to enrolment.
6Patient must have adequate renal function (Serum creatinine <= 1.5 times of ULN and Cockcroft-Gault creatinine clearance >= 60 ml/min.
7Patient must have adequate hepatic function (Serum bilirubin <= 1.5 times of ULN and AST/ALT <= 2.0 times of ULN).
8Subjects 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.
9Patient and /or LAR or impartial witness able to give written informed consent for participation in the trial.
10Patients with life expectancy of at least three months.
11In the opinion of the investigator, patient should be able to comply with study procedures.
12Sexually 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.
13In 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.
i.Known hypersensitivity to Bortezomib or to any of the excipients, Cyclophosphamide and Dexamethasone.
ii.If the patient had undergone prior surgery, chemotherapy, or other anti- cancer therapy within 4 weeks (28 days), thalidomide within 2 weeks prior to dosing in the study.
iii.Patients with known human immunodeficiency virus (HIV) infection.
iv.A positive hepatitis screen including HBSAg and HCV antibodies.
v.Use of any recreational drugs or history of drug addiction.
vi.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.
vii.History of venous thromboembolism or disease that aggravate risk for thromboembolism.
viii.Patients taking concurrent medications at entry that may act as inhibitors/inducers of CYP3A4.
ix.Patients with cardiac disease, grade 2 neuropathy, pulmonary, hepatic, gastrointestinal, endocrine, immunologic, dermatological, musculo-skeletal, psychiatric, neurological, proven amyloidosis and secondary malignancy.
x.Patient with a history of difficulty in donating blood or difficulty in accessibility of veins.
xi.Patient participated in any study and donated blood within 90 days prior to the current study.
xii.Female patients with pregnancy or breast-feeding.
xiii.Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study treatment.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare Cmax and AUC0-t of test and reference productsTimepoint: During the entire duration of the trial
- Secondary Outcome Measures
Name Time Method â?¢To compare Emax and AUE0-t of test and reference products administered. <br/ ><br>â?¢To assess the injection site reactions (local tolerability) of the investigational drug product(s). <br/ ><br>â?¢To monitor adverse events and ensure the safety of subjects. <br/ ><br>Timepoint: During the entire duration of the trial