Health Condition 1: null- Multiple Myeloma
Conditions
Interventions
Intervention1: Velcade Subcutaneous: Vecade will be given Subcutaneously in the Test arm, Dose 1.3 mg/m2 on day 1, 4, 8 and 11 of each cycle. Total 6 such cycles will be given to patient.
Control Inte
Sponsors
Johnson and Johnson Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects 18 years or older Diagnosis of multiple myeloma based on the standard criteria described in Attachment 1. 3. Measurable, secretory multiple myeloma defined as a serum monoclonal IgG of ≥10 g/L or a serum monoclonal IgA, IgD,or IgE ≥5 g/L, or urine M-protein of ≥200 mg/24 hr 4. Relapse or progression of myeloma following prior systemic antineoplastic therapy. Relapse or progression is defined by any of the following: ? Reappearance of measurable disease (as defined above) following CR ? ≥25% increase in serum or urine M-protein ? Development of new or worsening lytic bone disease ? New plasmacytomas or ≥50% increase in the longest dimension of an existing plasmacytoma ? Worsening hypercalcemia (corrected serum Ca 11.5 mg/dL [2.8 mmol/L]) due to multiple myeloma 5. Karnofsky performance status ≥70% (Attachment 2) 6. Platelet count ≥50 x 109/L without transfusion support within 7 days before the laboratory test 7. Hemoglobin ≥8 g/dL (≥4.96 mmol/L) without transfusion support within 7 days before the laboratory test. 8. Absolute neutrophil count (ANC) ≥0.75 x 109/L. 9. Corrected serum Ca 14 mg/dL (3.5 mmol/L) 10. Aspartate aminotransferase (AST) ≤2.5X upper limit of normal (ULN) 11. Alanine aminotransferase (ALT) ≤2.5X ULN 12. Total bilirubin ≤1.5X ULN (except in subjects with congenital bilirubinemia, such as Gilbert syndrome) 13. Creatinine clearance ≥20 mL/min, calculated using the formula 14. Toxic effects of previous therapy or surgery have resolved to CTCAE Grade 1 or better 15. Women who are not post-menopausal or surgically sterile must have a negative pregnancy test and agree to use an acceptable method of birth control during the study until 30 days after the last dose of study drug. 16. Men must agree to not father a child and agree to use a latex condom during treatment and for 30 days after the last dose of study drug, even if they have had a successful vasectomy, if their partners are of childbearing potential. 17. Voluntary written informed consent must be given before performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with VELCADE 2. More than 3 previous lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a 6 month treatment-free interval) 3. Peripheral neuropathy or neuropathic pain of NCI CTCAE Grade ¡Ý2 4. Any of the following within 3 weeks prior to randomization:antineoplastic or experimental therapy, corticosteroid use above10 mg/day (prednisone or equivalent), or plasmapheresis 5. Any of the following within 2 weeks prior to randomization: radiation therapy, major surgery (kyphoplasty is not considered major surgery) 6. Prior malignancy other than multiple myeloma diagnosed or treated within the last 2 years, with the exception of completely resected carcinoma in situ or basal/squamous carcinoma of the skin. 7. Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or clinically significant conduction system abnormalities 8. Concurrent medical condition or disease (e.g., active systemic infection, uncontrolled diabetes, therapeutic use of anticoagulants)that is likely to interfere with study procedures or results (including local injection tolerability), that in the opinion of the investigator would constitute a hazard for participating in this study 9. History of allergic reaction attributable to compounds containing boron or mannitol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to compare the overall response rate ORR (CR+PR), after 4 cycles, of subcutaneously (SC) administered VELCADE to intravenously (IV) administered VELCADE in patients with previously treated multiple myeloma.Timepoint: 21 day cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| To describe the plasma pharmacokinetics and pharmacodynamics (via whole blood 20S proteasome inhibition assay) of SC administered VELCADE as compared to IV administered VELCADETimepoint: 21 day cycle;To determine the CR, nCR, and VGPR rates after 4 cycles of single-agent VELCADE, the ORR after 8 cycles including the effect of adding dexamethasone, the duration of response (DOR), time to disease progression (TTP), progression-free survival (PFS), 1-year survival, and time to response following VELCADE treatment, administered either SC or IVTimepoint: 21 day cycle;To evaluate the safety and tolerability of the 2 routes of administration,including the local tolerability of SC administrationTimepoint: 21 day cycle | — |
Countries
Belgium, Canada, France, India, Netherlands, Poland, Ukraine, United Kingdom
Contacts
Public ContactRavinder Tyagi
Outcome results
None listed