Tolerability of dose escalation of ibandronate in patients with multiple myeloma and end-stage renal disease: a case series.

BACKGROUND: Bone disease is a feature of multiple myeloma (MM). Many patients have compromised renal function and sometimes develop end-stage renal disease (ESRD). For these patients, presently there exists no approved bisphosphonate, which is an elementary part of the standard therapeutic regimen of MM. PATIENTS AND METHODS: We evaluated the tolerability of ibandronate 2-6 mg every 4 weeks in patients with MM and ESRD receiving regular hemodialysis over 12 weeks (open-label, single-center, observational study). Ibandronate pharmacokinetics were measured until the end of the next dialysis. Adverse events were recorded.
RESULTS: 8 patients received ibandronate (average duration 5.6 months). Urinary excretion ranged from 0.15 to 341.9 microg/24 h. Mean ibandronate peak levels increased in a dose-dependent manner (2 mg: 141.4 +/- 67.0 ng/ml; 4 mg: 298.5 +/- 82.0 ng/ ml; 6 mg: 564.3 +/- 318.9 ng/ml). No adverse events were reported.
CONCLUSION: Based on these results and published bisphosphonate data, we have decided to offer off-label ibandronate treatment to MM patients receiving hemodialysis.