Background & objective: Thalidomide is effective in treating refractory and relapsed multiple myeloma (MM). However, the efficacy of thalidomide in induction therapy for newly diagnosed MM remains unknown. This study was to evaluate the efficacy of thalidomide combined dexamethasone (TD induction regimen) on previously untreated MM, and observe the adverse events.
Methods: Thirty-nine patients with newly diagnosed MM received oral administration of thalidomide at a dose of 100-300 mg/day continuously and dexamethasone at a dose of 20-40 mg/day on Days 1-4, 9-12, 17-20 in odd months and on Days 1-4 in even months. TD regimen was repeated every 28 days. Thirty-six MM patients who received VAD regimen (vindesine, adriamycin, and dexamethasone) was regarded as a historical matched controls. The efficacy, survival time and adverse events were compared between the two groups.
Results: The overall response rates were 71.8% in TD group and 61.1% in VAD group (P>0.05). The median progression-free survival was 14 months in TD group and 9 months in VAD group (P>0.05). Within a median follow-up of 13 months (range, 1-30 months), median overall survival (OS) was not reached in TD group, and was 29 months in VAD group. The most common adverse events (always not higher than grade 2) were constipation, fatigue, dizziness and somnolence in TD group. More grade 3-4 adverse events, included leucopenia and thrombocytopenia, and higher infection rate were observed in VAD group as compared with those in TD group (P<0.05).
Conclusions: The combination of thalidomide and dexamethasone is an effective induction regimen for newly diagnosed MM. It may be considered as a replacement of VAD regimen.