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.


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.


CONCLUSIONS
Based on these results and published bisphosphonate data, we have decided to offer off-label ibandronate treatment to MM patients receiving hemodialysis.
Henrich
Dirk M
DM
Dialysezentrum Saarlouis, Saarlouis, Germany. henrich@dialyse-saarlouis.de
Hoffmann
Martin
M
Uppenkamp
Michael
M
Bergner
Raoul
R
D000368:Aged; D000369:Aged, 80 and over; D050071:Bone Density Conservation Agents / Q000008:administration & dosage; D004164:Diphosphonates / Q000008:administration & dosage* / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D000077557:Ibandronic Acid; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy*; D016896:Treatment Outcome
D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D000077557:Ibandronic Acid