Bioequivalence study of Bortezomib for Injection 3.5 mg/vial in previouslyuntreated Multiple Myeloma and/or Relapsed/Refractory Multiple Myeloma patients.
- Conditions
- Previously untreated Multiple Myeloma and/or Relapsed/Refractory Multiple Myeloma patients.
- Registration Number
- CTRI/2015/05/005758
- Lead Sponsor
- Dr Reddys Laboratories Limited
- Brief Summary
This is a Multicentre, Open label, Balanced, Randomized, Two-Treatement, Two-Period, Single dose, Crossover bioequivalence of the Test Product (Bortezomib for Injection 3.5 mg/vial of Dr. Reddy’s Laboratories Limited, India) relative to that of Reference Product (VELCADE® (bortezomib) for Injection 3.5 mg/vial (Distributed by: Millennium Pharmaceuticals, Inc., 40 Landsdowne Street, Cambridge, MA 02139)) in previously untreated Multiple Myeloma and/or Relapsed/Refractory Multiple Myeloma patients. **Reconstitution Procedure**: Add 1.4 mL of sterile 0.9% sodium chloride solution to theBortezomib powder contained in the vial. The final reconstituted concentration will be 2.5 mg/mL. The reconstituted product should be a clear and colourless solution free of particulate matter. Reconstitution will be done within 1 hr prior to dosing. Bortezomib 3.5 mg/vial reconstituted solution (with final Bortezomib concentration of 2.5 mg/mL) will be administered subcutaneously in abdomen (right or left). The solution should be injected subcutaneously, at a 45-90° angle. A total of 32 blood samples each of 4 mL will be collected from each patient for PK assessment and 20 samples, each of 3mL for PD assessment during the study. Venous blood samples will be withdrawn for each patient on Day 32 (Period 1) and Day 53 (Period 2) for PK and PD assessments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 64
- 1.Patients with histopathologically/cytologically confirmed multiple myeloma.
- 2.Adult patients with previously untreated Multiple Myeloma or Relapsed/Refractory Multiple Myeloma for whom Bortezomib is considered as suitable treatment as per the Principal Investigator judgement.
- 3.Patient with an ECOG performance status of 0-2.
- 4.Patient must have an adequate bone marrow, renal and hepatic function 5.Life expectancy should be ≥3 months.
- 1.Known hypersensitivity to Bortezomib, Boron, Tromethamine, Citric acid or to any of the excipients, Melphalan and Prednisone (for previously untreated Multiple Myeloma patients) 2.If the patient had undergone prior surgery, radiation, chemotherapy, or other anticancer therapy within 4 weeks (28 days) prior to the start of Bortezomib therapyin the study 3.Patients with positive human immunodeficiency virus (HIV) infection.
- 4.A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
- 5.Use of any recreational drugs or history of drug addiction.
- 6.A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds (ms)).
- 7.A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) 8.The use of concomitant medications that prolong the QT/QTc interval 9.Acute diffuse infiltrative pulmonary and pericardial disease.
- 10.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
- 11.Patients who are receiving strong CYP3A4/CYP2C19/CYP1A2 – inhibitors and/or inducers and in whom these drugs are unable to be restricted for the entire study period.
- 12.Peripheral Neuropathy Grade 1 with pain or Grade 2 and above.
- 13.End Stage Renal Disease.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the Bioequivalence between Bortezomib for Injection 3.5 mg/vial of Dr. Reddy’s Laboratories Limited, India and VELCADE® (bortezomib) for Injection 3.5 mg/vial (Distributed by: Millennium Pharmaceuticals, Inc., 40 Landsdowne Street, Cambridge, MA 02139) in previously untreated Multiple Myeloma and/or Relapsed/Refractory Multiple Myeloma patients. PK assessment Pre-dose (0.000) and at 0.083, 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.500, 3.000,6.000, 9.000, 12.000, 24.000, 48.000 and 72.000 hrs post dose. | PD assessment:Pre-dose (0.000) and 0.333, 0.500, 1.000, 2.000, 4.000, 12.000, 24.000, 48.000 and 72.000 hrs post-dose.
- Secondary Outcome Measures
Name Time Method 1.To monitor the safety and tolerability of the patients exposed to the Investigational Medicinal Product.
Trial Locations
- Locations (19)
Amrita Institute of Medical Sciences
🇮🇳Ernakulam, KERALA, India
Apple Hospital
🇮🇳Surat, GUJARAT, India
Central India Institute of Hematology and Oncology
🇮🇳Nagpur, MAHARASHTRA, India
Curie Manvanta Cancer Centre
🇮🇳Nashik, MAHARASHTRA, India
Dr GVN Cancer Institute
🇮🇳Tiruchirappalli, TAMIL NADU, India
Guru Hospital
🇮🇳Madurai, TAMIL NADU, India
Healthcare Global Enterprises Ltd.
🇮🇳Bangalore, KARNATAKA, India
KEM Hospital Research Centre
🇮🇳Pune, MAHARASHTRA, India
Mazumdar Shaw Medical Center, Narayan Hrudayalaya Hospitals
🇮🇳Bangalore, KARNATAKA, India
Meenakshi Mission Hospital & Research Centre
🇮🇳Madurai, TAMIL NADU, India
Scroll for more (9 remaining)Amrita Institute of Medical Sciences🇮🇳Ernakulam, KERALA, IndiaDr pavithran KeechilatPrincipal investigator09895367090bhajanlalk@aims.amrita.edu