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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
1. To determine response rates (RR) and disease progression rates in all MM patients treated with dtZ regimen.
Gerrard Teoh, MD
Gleneagles Hospital, Singapore
Singapore: Health Sciences Authority