EUCTR2008-000952-28-DE
Active, not recruiting
Not Applicable
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 enrollmentApril 16, 2008
ConditionsThe 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 criteriaMedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- 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
- Sponsor
- Janssen-Cilag International NV (JCI)
- Enrollment
- 216
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
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 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
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
Outcomes
Primary Outcomes
Not specified
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