Comparative Trial inMultiple Myeloma Patients of Oral Ibandronic Acid versus Intravenous Zoledronate: a phase III study
- Conditions
- Multiple Myeloma
- Registration Number
- EUCTR2005-003770-23-AT
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 424
•Patients with multiple myeloma & confirmation of bone lesions
•Age > 18 years
•Patient’s written informed consent
•WHO performance status 0-2
•Life expectancy of ? 6 months
•Adequate renal function (defined by a creatinine clearance >60 ml/min)
•No history of brain metastases
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
•Any circumstance liable to compromise follow-up and compliance
•Pregnant or lactating period
•Participation in a clinical trial with any investigational drug within 4 weeks preceding the first dose of the study drug
•History of other concomitant cancer in evolution
•Prior bisphosphonate treatment with the exception of bisphosphonate treatment for hypercalcemia and osteoporosis
•Pre-scheduled radiotherapy that would fall within the study period
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method