Comparison of therapeutic effect between thalidomide with and without alkylating agents on patients with new-onset multiple myeloma

Objective To compare the efficacy and toxicity of thalidomide-COMP (T-COMP) and thalidomide-VAD (T-VAD) regimens in previously untreated multiple myeloma (MM) patients.Methods Forty-nine newly diagnosed MM patients were randomly allocated to either A group (thalidomide-MP/-COMP,19 cases) or B group (thalidomide-VAD,30 cases).All patients received thalidomide 200 mg p.o.daily.Patients in group A received additionally vincristine 0.4 mg i.v.on day 1-4,cyclophosphamide 200 mg i.v.on day 1-4,melphalan 4 mg tid p.o.on days 1-5,prednisone 60 mg p.o.daily on days 1-5.Patients in group B received additionally vincristine 0.4 mg i.v.on day 1-4 and epirubicin 10 mg/m2 i.v.,on day 1-4 and dexamethasone 40 mg p.o.daily on days 1-4,9-12 and 17-20 for the first cycle and on days 1-4 for the next three cycles.Treatment was administered every 28 days.The therapeutic response was evaluated based on the International Myeloma Working Group Criteria (IMWG 2006) after the treatment.The toxicity was graded according to NCI common terminology criteria for adverse events v 3.0.Results On an intention-to-treat basis,at least partial therapeutic response was observed.The rates were 73.7 ％ and 53.3 ％ in group A and B respectively (x2 =2.029,P =0.154).Overall survival (OS) rate at 2 years were 52.6 ％ (10/19) in group A and 53.3 ％ (16/30) in group B,respectively (x2 =2.468,P =0.116).Considering overall toxicity,constipation,peripheral neuropathy,dizziness/somnolence,skin rash and edema were significantly higher in group B compared with group A,but the incidence of toxicities grade 3-4 was low and similar in both arms.Conclusion The overall response rate of T-MP/T-COMP regimen is similar with that of T-VAD regimen,suggesting this regimen cannot be chosen as the first treatment for patients with non-implantation therapy. Key words: Multiple myeloma ;  Thalidomide ;  Alkylating agent