Safety evaluation of the i.v. administration of Visipaque in patients with myeloma or monoclonal gammopathy - ND
- Conditions
- multiple myeloma, Waldenstrom disease o MGUS and lung cancer patients (control groupMedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma
- Registration Number
- EUCTR2006-002655-33-IT
- Lead Sponsor
- ISTITUTO EUROPEO DI ONCOLOGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
patients with multiple myeloma, Waldenstrom disease o MGUS and lung cancer patients (control group
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
age less than 18 or greater than 71. renal function impairment (SCr > 1.5 mg/dL for women and > 1.7 for men. diabetes. intolerance to iodine containing contrast media. concomitant treatment with nephrotoxic drugs.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate the effect on renal function of i.v. Visipaque administration and to define the suitability and relative risk of CT scan examination which is necessary for the staging of these patients appropriatness;Secondary Objective: none;Primary end point(s): renal function impairment evaluated through NAG escretion 24 hours after the administration of the contrast media; livelli di Creatinina serica 72 ore dopo la somministrazione del contrasto; Clearance della Creatinina 72 ore dopo l'assunzione di contrasto
- Secondary Outcome Measures
Name Time Method