Health Condition 1: null- Multiple Myeloma Health Condition 2: D728- Other specified disorders of whiteblood cells
Conditions
Interventions
Intervention1: Bortezomib for Injection 3.5 mg/vial of Dr. Reddy�s Laboratories Limited: single subcutaneous (sc) dose of injection Bortezomib (1.3 mg/m2) as per the randomization schedule
Cont
Sponsors
Dr Reddys Laboratories
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients willing and able to give written informed consent for participation in the trial. 2.Male or female patients with age 18 to 65 years (both inclusive) at the screening visit. 3.Patients with confirmed diagnosis of Multiple Myeloma. 4.Adult patients with previously untreated Multiple Myeloma or Relapsed Multiple Myeloma (who have previously responded to treatment with Bortezomib based regimen and who have relapsed at least 6 months after completing prior Bortezomib based treatment) for whom Bortezomib is considered as suitable treatment as per the Principal Investigator judgement. 5.Subject with an ECOG performance status of 0-1 (Annexure II). 6.Subject must have an adequate bone marrow, renal and hepatic function Body system Parameters I. Bone marrow function ANC more than or equal to 1500/mm3 II. Platelet count more than or equal to 1,00,000/mm3 III. Haemoglobin more than or equal to 8.0 g/dL IV. Renal function Serum Creatinine less than or equal to 1.5 times ULN and Creatinine clearance more than 60 ml per minutes (Cockcroft-Gault) IV. Hepatic function Serum Bilirubin less than 1.5 times ULN, ALT/AST less than or equal to 2.0 times ULN 7.Patient should be able to comply with study procedures in the opinion of the investigator. 8.Non-smokers or ex-smokers who have not taken any nicotine-containing products in the last 6 months before Day 1 of dosing of this study. 9. Sexually 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. In case of male patients: Male patients must agree to practice complete abstinence or agree to use a condom during sexual contact with a FCBP even if they have had a successful vasectomy. Patients must use an effective method of avoiding pregnancy, during study and up to 60 days after the last dose of study drug. In addition, the male patients must agree not donate sperm while participating in the study and up to 60 days after the last dose of study drug.All study participants must be willing and able to comply with the applicable requirements of the Lenalidomide REMS�® program.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to Bortezomib, Boron, Tromethamine, Citric acid or to any of the excipients, Lenalidomide and Dexamethasone. 2. If the patient had undergone prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks (28 days), thalidomide within 2 weeks prior to dosing in the study 3. Patients with known human immunodeficiency virus (HIV) infection. 4. A positive hepatitis screen including hepatitis B surface antigen and HCV 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)) 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. 7. History of venous thromboembolism or disease that aggravate risk for thromboembolism. 8. Myocardial infarction within 6 months prior to enrolment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. 9. 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. 10. Clinically relevant active infection requiring treatment (antibiotics, antivirals, antifungals).Serious psychiatric illness or addiction likely to interfere with participation in this clinical study. 11. Uncontrolled diabetes mellitus (HbA1c greater than 8% despite medical treatment) 12. The receipt of an investigational medicinal product within a period of 90 days prior to the first dose of Investigational Medicinal Product for the current study. 13. Patient with a history of difficulty in donating blood or difficulty in accessibility of veins. 14. Acute diffuse infiltrative pulmonary and pericardial disease. 15. Peripheral Neuropathy Grade 1 with pain or Grade 2 and above. 16. Any other health condition or abnormal baseline assessment findings that, in the investigatorââ?¬•s judgement, could increase the risk to the subject. 17. Patients who are receiving strong CYP3A4/CYP2C19/CYP1A2 ââ?¬â?? inhibitors and/or inducers or grapefruit juice and in whom these drugs are unable to be restricted for the entire study period. 18. Female subject is pregnant or breast-feeding. 19. Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the bioequivalence of the Test Product (Bortezomib for Injection 3.5 mg/vial of Dr. Reddyââ?¬â?¢s Laboratories Limited, India) relative to that of Reference Product (VELCADEÃ?® (bortezomib) for Injection 3.5 mg/vial (Distributed and Marketed by: Millennium Pharmaceuticals, Inc., 40 Landsdowne Street, Cambridge, MA 02139)) in previously untreated Multiple Myeloma and/or Relapsed Multiple Myeloma patients. Timepoint: Blood sampling upto 72.00 hrs for PK assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of the patients exposed to the Investigational Medicinal Product.Timepoint: Physical examination, vital signs, ECG, laboratory evaluations and adverse event monitoring | — |
Countries
India
Contacts
Public ContactDr Pranjal Bordoloi
Veeda Clinical Research Pvt Ltd
Outcome results
None listed