Renal safety of zoledronic acid with thalidomide in patients with myeloma: a pharmacokinetic and safety sub-study.

Authors: Andrew Spencer, Andrew Roberts, Nola Kennedy, Christina Ravera, Serge Cremers, Sanela Bilic, Terry Neeman, Michael Copeman, Horst Schran, Kevin Lynch
BMC Clin Pharmacol 2008 Mar 31;8. Epub 2008 Mar 31.
Department of Haematology and Bone Marrow Transplantation, The Alfred Hospital, Prahan, Victoria, Australia.
March 2008

Background: Cases of impaired renal function have been reported in patients who had been treated with both zoledronic acid and thalidomide for myeloma. Hence, we conducted a safety study of zoledronic acid and thalidomide in myeloma patients participating in a trial of maintenance therapy.

Methods: Twenty-four patients who were enrolled in a large randomized trial of thalidomide vs no thalidomide maintenance therapy for myeloma, in which all patients also received zoledronic acid, were recruited to a pharmacokinetic and renal safety sub-study, and followed for up to 16 months.

Results: No significant differences by Wilcoxon rank-sum statistic were found in zoledronic acid pharmacokinetics or renal safety for up to 16 months in patients randomized to thalidomide or not.

Conclusion: In myeloma patients receiving maintenance therapy, the combination of zoledronic acid and thalidomide appears to confer no additional renal safety risks over zoledronic acid alone.