Overview

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