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

Andrew Spencer¹ , Andrew Roberts² , Nola Kennedy¹ , Christina Ravera³ , Serge Cremers³ , Sanela Bilic³ , Terry Neeman⁴ , Michael Copeman⁵ , Horst Schran³ and Kevin Lynch⁵

¹Department of Haematology and Bone Marrow Transplantation, The Alfred Hospital, Prahan, Victoria, Australia

²Department of Haematology, Royal Melbourne Hospital, Parkville, Victoria, Australia

³Department of Clinical Pharmacology, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, USA

⁴Covance Pty. Ltd., Canberra, ACT, Australia

⁵Novartis Pharmaceuticals Australia Pty. Ltd., 54 Waterloo Rd, North Ryde NSW 2113, Australia

author email corresponding author email

BMC Clinical Pharmacology 2008, 8:2doi:10.1186/1472-6904-8-2


Published:	31 March 2008

Abstract

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.