Randomized, two arm, controlled study to compare the efficacy oforal ibandronate treatment versus intravenous zoledronate in patientswith symptomatic Multiple Myeloma

Phase 1

Conditions: Multiple Myeloma

Registration Number: EUCTR2005-003770-23-SK

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

Inclusion Criteria

•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

Exclusion Criteria

•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
Main Objective: To assess the efficacy of oral ibandronic acid 50 mg compared to intravenous zoledronate based on proportion of patients with Skeletal Related Event’s (SREs, defined as fractures, the need for radiotherapy to bone, the need for surgery to bone or spinal cord compression) in patients with symptomatic Multiple Myeloma.;Primary end point(s): •Proportion of patients with SREs;Secondary Objective: •To asses the efficacy of oral ibandronic acid 50 mg compared to standard bisphosphonate therapy on:<br>•Time to first SRE<br>•Skeletal Morbidity Rate (SMR)<br>•Time to multiple SREs by multivariate analyses <br>•Bone pain and analgesic use<br>•Overall survival<br><br>•To assess the safety and tolerability profile of oral ibandronic acid versus intravenous zoledronate, with specific emphasis on renal Adverse Events (AEs) and acute phase AEs (within 3 days of dosing)<br>

Secondary Outcome Measures