Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs Health Condition 2: null- Relapsed/Refractory Multiple Myeloma Patients
Conditions
Interventions
Intervention1: Bortezomib powder for solution for Injection: Dose: Single Dose (1.3 mg/m2)
Mode of administration: Subcutaneous
Control Intervention1: VELCADE powder for solution for injection: Dose:
Sponsors
Dr Reddys Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient and /or LAR or impartial witness able to give written informed consent for participation in the trial 2. Patients with histopathologically/cytologically confirmed multiple myeloma 3. Patient with an ECOG performance status of 0-2 4. Patient must have an adequate bone marrow, renal and hepatic function 5. Patient should be able to comply with study procedures in the opinion of the investigator 6. Life expectancy should be >3 months
Exclusion criteria
Exclusion criteria: 1. Known hyper sensitivity to bortezomib, boron or to any of the excipients 2. If the patient had undergone prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks (28 days) 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, HCV and HAV antibodies 5. Any other condition or abnormal baseline findings that, in the investigatorâ??s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study 6. The receipt of an investigational medicinal product within a period of 30 days prior to the first dose of Investigational Medicinal Product for the current study 7. Patient with a history of difficulty in donating blood or difficulty in accessibility of veins 8. Acute diffuse infiltrative pulmonary and pericardial disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax and AUC(0-72)Timepoint: The primary endpoint will be assessed at following time points at pre-dose (0.000) and 0.083, 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.500, 2.000, 4.000, 6.000, 8.000, 10.000, 12.000, 24.000, 48.000 and 72.000 hrs post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, SafetyTimepoint: Clinical Examination: At screening, at the time of check-in, checkout. Vitals: At screening, check-in day, predose, at various times following drug administration, Urine Scan for drug of abuse:- check-in day Breath test for Alcohol consumption:- check-in Immunological tests [HBsAg, HAV (IgM) and HCV antibody] will be done at screening. ECG and ECHO evaluation: Pregnancy test (for female volunteers): Screening (Serum), Day 01 (Urine) and at the end of study (Serum) Hematology; Blood chemistry | — |
Countries
India
Contacts
Public ContactDr Praveen Shetty
Lambda Therapeutic Research Ltd
Outcome results
None listed