Renal safety of zoledronic acid with thalidomide in patients with myeloma: a pharmacokinetic and safety sub-study
1 Department of Haematology and Bone Marrow Transplantation, The Alfred Hospital, Prahan, Victoria, Australia
2 Department of Haematology, Royal Melbourne Hospital, Parkville, Victoria, Australia
3 Department of Clinical Pharmacology, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, USA
4 Covance Pty. Ltd., Canberra, ACT, Australia
5 Novartis Pharmaceuticals Australia Pty. Ltd., 54 Waterloo Rd, North Ryde NSW 2113, Australia
BMC Clinical Pharmacology 2008, 8:2 doi:10.1186/1472-6904-8-2Published: 31 March 2008
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.
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.
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.
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.