Trial Information

An International, Multicenter, Non-Randomized, Open-Labeled Study to Evaluate the Efficacy of Lower Dose Dexamethasone/Thalidomide and Higher Frequency ZOMETA(TM) in the Treatment of Previously Untreated Patients With Multiple Myeloma

Patients with newly-diagnosed multiple myeloma (MM) may be treated using monthly cycles of
dexamethasone plus thalidomide (DT). Unfortunately, the use of conventional doses of DT is
associated with significant treatment-related morbidity and mortality, which is comparable
to that observed with conventional chemotherapy. Hence, for safety reasons, patients
frequently receive lower than conventional doses of DT (i.e. dt), and potentially experience
a poorer anti-MM effect. The highly-potent aminobisphosphonate, zoledronic acid (Z), has
been shown in pre-clinical mouse models to exhibit an impressive anti-MM effect. It is
therefore possible to combined dt with Z (i.e. dtZ) to enhance the efficacy of (lower dose)
dt. In addition, the anti-tumor effect of dtZ may potentially be augmented by using Z at a
higher (three-weekly) dosing frequency.