An Open-label, Randomized Study of Subcutaneous and Intravenous VELCADE® in Subjects With Previously Treated Multiple Myeloma

Janssen-Cilag International NV (JCI)0 sites216 target enrollmentNovember 27, 2008

DrugsVELCADE Fortecortin Fortecortin (dexamethasone)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Janssen-Cilag International NV (JCI)
Enrollment: 216
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 27, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Janssen-Cilag International NV (JCI)

Eligibility 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 the standard criteria described in Attachment 1\.
•3\.Measurable, secretory multiple myeloma defined as serum monoclonal IgG of \=10 g/L, serum monoclonal IgA or IgE \=5 g/L, or serum monoclonal IgD \=0\.5g/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

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 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, pericardial disease, acute diffuse infiltrative pulmonary disease, 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 dexamethasone or its constituents, or compounds containing boron or mannitol