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


CONCLUSIONS
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.
Spencer
Andrew
A
Department of Haematology and Bone Marrow Transplantation, The Alfred Hospital, Prahan, Victoria, Australia. aspencer@netspace.net.au
Roberts
Andrew
A
Kennedy
Nola
N
Ravera
Christina
C
Cremers
Serge
S
Bilic
Sanela
S
Neeman
Terry
T
Copeman
Michael
M
Schran
Horst
H
Lynch
Kevin
K
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D003404:Creatinine / Q000097:blood; D004164:Diphosphonates / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D007668:Kidney / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000097:blood / Q000188:drug therapy*; D011239:Prednisolone / Q000008:administration & dosage; D013792:Thalidomide / Q000008:administration & dosage; D000077211:Zoledronic Acid
D000970:Antineoplastic Agents; D004164:Diphosphonates; D007093:Imidazoles; D013792:Thalidomide; D000077211:Zoledronic Acid; D011239:Prednisolone; D003404:Creatinine