Clinical Study On Bortezomib And Thalidomide In The Treatment Of Multiple Myeloma

【Objectives】To investigate the efficacy and safety of bortezomib based chemotherapy for elderly, newly diagnosed and relapsed or refractory multiple myeloma patients. To evaluate the efficacy of thalidomide and dexamethasone as induction therapy regimen in previously untreated multiple myeloma.【Methods】A controlled randomized prospective study and a historical controlled study was independently carried out to compare the efficacy and adverse events in bortezomib or without bortezomib based therapy for previously untreated, elderly myeloma patients(9 patients was enrolled) and 46 patients with refractory or relapsed myeloma. A retrospective matched case-control study on the treatment of 39 newly diagnosed myeloma patients with thalidomide and dexamethasone was also performed. Response to bortezomib was evaluated according to the criteria of the IMWG and adverse events were graded according to the NCI CTCAE 3.0.【Results】The overall response rate of bortezomib based combination therapy for newly diagnosed, elderly MM patients was 100.0% compared with 83.3% in the control group. Among the patients with relapsed or refractory MM, the response rate in the treatment group and control group was 72.1% and 51.0%(p<0.05), respectively. The adverse events were tolerated. Furthermore, there was 71.8% patients with previously untreated MM by use of Thal-Dex achieved response above PR compared with 61.1%(p>0.05) in the control group. The hematological toxicities were slightly.【Conclusions】Bortezomib based combination therapy is a new effective way in newly diagnosed and relapsed or refractory myeloma patients with a higher response rate and lower toxicities. The combination of thalidomide and dexamethasone is an effective induction therapy regimen for previously untreated multiple myeloma.