The subject population comprises adult male and female subjects with multiple myeloma that has relapsed or progressed after prior systemic antineoplastic therapy, presence of measurable secretory disease, Karnofsky performance status score greater than or equal to 70%, and clinical hematology and chemistry laboratory values that meet predefined criteria MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: VELCADE
Product Name: VELCADE
Product Code: JNJ-26866138
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: VELCADE (bortezomib)
CAS Number: 179324-69-7
Current Sp
Sponsors
Janssen-Cilag International NV (JCI)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Potential subjects must satisfy the following criteria to be enrolled in the study: 1. Male or female subjects 18 years or older 2. Diagnosis of multiple myeloma based on criteria provided in the protocol 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% 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. Treatment with EPO is allowed. 8. Absolute neutrophil count (ANC) =0.75 x 109/L. 9. Corrected serum Ca =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: 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 =2 4. Any of the following within 3 weeks prior to randomization: antineoplastic or experimental therapy, corticosteroid use above 10 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) that is likely to interfere with study procedures or results, or 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 |
|---|---|
| Main Objective: The primary objective is to compare the overall response rate ORR (CR+PR), after 4 cycles, of subcutaneously (SC) administered VELCADE® and intravenously (IV) administered VELCADE® in patients with previously treated multiple myeloma.;Secondary Objective: The secondary objectives are: - 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 IV, - to evaluate the safety and tolerability of the 2 routes of administration, including the local tolerability of SC administration - to describe the plasma pharmacokinetics and pharmacodynamics (via 20S proteasome inhibition assay) of SC administered VELCADE® as compared to IV administered VELCADE® ;Primary end point(s): The primary endpoint of the study is the overall response rate ORR (CR+PR) after 4 cycles (prior to the addition of dexamethasone) for the SC group and the IV group. | — |
Countries
Belgium, France, Germany, United Kingdom
Outcome results
None listed