Zoledronic acid as compared with observation in multiple myeloma patients at biochemical relapse: Results of the randomized AZABACHE Spanish trial

This is an open-access paper.-- This trial was registered in the ClinicalTrials.gov database with code NCT01087008.
Spanish Myeloma Group (GEM/PETHEMA): et al.
This study analyzed the anti-myeloma effect of zoledronic acid monotherapy by investigating patients at the time of asymptomatic biochemical relapse. One hundred patients were randomized to receive either zoledronic acid (4 mg iv/4 weeks, 12 doses) (n=51) or not (n=49). Experimental and control groups were well balanced for disease and prognostic features. Zoledronic acid did not show an antitumor effect according to changes in M-component. However, there were fewer symptomatic progressions in the experimental group than in the control group (34 versus 41, respectively; P=0.05) resulting in a median time to symptoms of 16 versus 10 months (P=0.161). The median time to next therapy was also slightly longer for the treated group than the untreated, control group (13.4 versus 10.1 months), although the difference was not statistically significant (P=0.360). The pattern of relapses was different for treated versus control patients: progressive bone disease (8 versus 20), anemia (24 versus 18), renal dysfunction (1 versus 2), and plasmacytomas (1 versus 1, respectively). This concurred with fewer skeletal-related events in the treated group than in the control group (2 versus 14), with a projected 4-year event proportion of 6% versus 40% (P
This work was supported by an unrestricted grant from Novartis Farmaceutica S.A., Barcelona, Spain and sponsored by GEM/PETHEMA. Part of the work was also done thanks to grants PS09/01450 and PI12/02311 from the Spanish “Instituto de Salud Carlos III (ISCIII)” and Fondo Europeo de Desarrollo Regional (FEDER), the Spanish Ministry of Economy and Competitiveness and the European Regional Development Fund (ERDF) “Una manera de hacer Europa” (Innocampus; CEI-2010-1-0010), the grant RD12/0036/0069 from “Red Temática de Investigación Cooperativa en Cáncer (RTICC), and grant GCB-120981SAN from the “Asociación Española Contra el Cáncer (AECC)”.