Health Condition 1: null- Previously untreated Multiple Myeloma and/or Relapsed/Refractory Multiple Myeloma patients.
Conditions
Interventions
Intervention1: Bortezomib for Injection 3.5 mg/vial: Patients will receive a single subcutaneous (SC) dose, 1.3 mg/m2 of Bortezomib, either
Test or Reference Product as per the randomization schedule
Sponsors
Dr Reddys Laboratories Limited
Veeda Clinical Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 â?? 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Bioequivalence between Bortezomib for Injection 3.5 mg/vial of Dr. Reddyâ??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.Timepoint: 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
| Measure | Time frame |
|---|---|
| 1.To monitor the safety and tolerability of the patients exposed to the Investigational Medicinal Product. 2.To characterize the Pharmacodynamics (20S Proteasome inhibition) in patients for exploratory purposesTimepoint: 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. | — |
Countries
India
Contacts
Public ContactDr Ashoka Singh
Veeda Clinical Research Pvt. Ltd.
Outcome results
None listed