EFFICACY AND SIDE EFFECTS OF MAINTENANCE THERAPY WITH THALIDOMIDE FOLLOWING STEM CELL TRANSPLANTATION IN PATIENTS WITH MULTIPLE MYELOMA

Abstract

Background and Objective: Various drugs used as maintenance therapy following transplantation have been assessed. Therefore the use of maintenance therapy to eliminate residual malignant cells is controversial yet. So, the aim of this study was to evaluate the efficacy and side effects of maintenance therapy with thalidomide following stem cell transplantation in patients with multiple myeloma. Methods: The open label trial was randomly performed on 73 patients with multiple myeloma who underwent Autologous Hematopoietic Stem Cell Transplantation (ASCT) with acceptable marrow recovery. Thirty-five patients assigned to thalidomide group and received 100 mg/day thalidomide after ASCT and 37 patients assigned to non-thalidomide group. All patients received acyclovir and cotrimoxazole for prophylaxis. Survival rate and complications were compared in two groups. Findings: Median age in thalidomide group was 52 years and in non-thalidomide group was 55 years. Twenty three (66) patients in thalidomide group and 36(95) patients in non-thalidomide group continued initial treatment. The median duration of thalidomide consumption was 13.2 months. The 2-year progression free survival rate was 63.4±0.10 for thalidomide group and 42.1±0.19 for non-thalidomide group (p=0.91). The 2-year overall survival rate was 82.1±0.09 for thalidomide group and 90.2±0.07 for non-thalidomide group (p=0.22). Totally 40 percent of patients developed thalidomide related complication. So most common complications include sensory and motor neuropathy and deep vein thrombosis (DVT). Conclusion: The results showed that there is no benefit to use thalidomide after SCT. With attention to thalidomide complications, it is recommended to reserve post-ASCT thalidomide maintenance primarily for patients with high-risk disease.