Comparison of Ibandronate - Zoledronate Regarding Nephrotoxicity in Multiple Myeloma

• Status: Terminated
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This multicenter, open-label trial will randomize participants with multiple myeloma to a regimen of ibandronate or zoledronate in order to compare the incidence of nephrotoxicity, measured as creatinine clearance (CrCl) reduction greater than (>) 30 percent (%) or an absolute value of 30 milliliters per minute (mL/min) or lower.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Roche Pharma AG
• Treatments: Diphosphonates; Ibandronic Acid; Zoledronic Acid

Criteria

Inclusion Criteria:

• Confirmed multiple myeloma, Stage II-III as per Salmon and Durie (1975)

• Indication for biphosphonate therapy

Exclusion Criteria:

• Previous therapy with ibandronate or zoledronate within the past 12 months

• Renal insufficiency with serum creatinine >3.0 mg/dL or >265 micromoles per liter (µmol/L) or CrCl <30 mL/min

• Hypersensitivity to ibandronate, zoledronate, or other biphosphonates

• Presence of secondary malignomas, apart from basaliomas and cervical carcinoma in situ

• Severe accompanying illness with organ impairment

• Osteonecrosis of the jaw at the start of the study

• Life expectancy ≤12 months