A prospective, multicenter, phase II study was performed to assess the efficacy and safety of thalidomide maintenance therapy at different doses in Japanese multiple myeloma (MM) patients. This study included 34 patients (median age, 74 years) who were previously treated with not more than three prior therapies and whose response status was evaluated as at least stable disease. They were randomized into Group A (no maintenance; 12 patients), Group B (50 mg thalidomide maintenance; 12 patients), and Group C (100 mg thalidomide maintenance; 10 patients), respectively. Thalidomide maintenance therapy resulted in improved depth of response in three cases (13.6%) and sustained response after induction therapy in eight cases (36.4%). Two-year progression-free survival (PFS) was 25.0%, 33.3%, and 77.8% in Groups A, B, and C, respectively, and was significantly higher in Group C than in Group A (p = 0.005). There was no difference in the incidence of hematological or non-hematological adverse events between Groups B and C. The current study demonstrates that maintenance with daily thalidomide at 100 mg, but not 50 mg, improved depth of response and prolonged PFS, and that this treatment was feasible for use in Japanese MM patients.
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The authors would like to thank Dr. Kunihiko Hayashi of the Department of Laboratory Sciences, Gunma University Graduate School of Health Sciences, for comments on the statistical analysis. This study was supported by the Epidemiological and Clinical Research Information Network (ECRIN).
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Conflict of interest
Dr. Murakami H received a research grant from Fujimoto Pharmaceutical Co. Ltd. and Celgen Co. Ltd, and served on scientific advisory boards and speakers’ bureaus for Celgen Co. Ltd., Sanofi K.K., and Ono Pharmaceutical CO, Ltd. Dr. Kiguchi T received a research grant from Celgen Co. Ltd., Sanofi K.K., and Janssen Pharmaceutical K.K. Other authors have no conflict of interest.
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