PURPOSE: For several decades, the treatment of elderly patients with multiple myeloma (MM) has consisted of melphalan and prednisone (MP). The Dutch-Belgium Hemato-Oncology Cooperative Group (HOVON) investigated the efficacy of thalidomide added to MP (MP-T) in a randomized phase III trial. The objective of this study was to investigate the efficacy, toxicity, and effects on quality of life of MP-T. PATIENTS AND METHODS: A randomized phase III trial compared standard MP with MP-T (thalidomide 200 mg/d) in newly diagnosed patients with multiple myeloma older than age 65 years. Maintenance therapy with thalidomide 50 mg/d was administered to patients after MP-T until relapse. The primary end point was event-free survival (EFS); response rate, overall survival (OS), and progression-free survival (PFS) were secondary end points. RESULTS: An intent-to-treat analysis of 333 evaluable patients showed significantly higher response rates in MP-T-treated patients compared with MP-treated patients a response (> or = partial response: 66% v 45%, respectively; P <.001; and > or = very good partial response [VGPR]: 27% v 10%, respectively; P <.001). EFS was 13 months with MP-T versus 9 months with MP (P <.001). OS was 40 months with MP-T versus 31 months with MP (P = .05). CONCLUSION: This study demonstrates that thalidomide improves the response rate and VGPR in elderly patients with newly diagnosed MM. MP-T also results in a better EFS, PFS, and OS.
Wijermans, P., Schaafsma, M., Termorshuizen, F., van Ammerlaan, R., Wittebol, S., Sinnige, H., ... Sonneveld, P. (2010). Phase III study of the value of thalidomide added to melphalan plus prednisone in elderly patients with newly diagnosed multiple myeloma: The HOVON 49 study. Journal of Clinical Oncology, 28(19), 3160-3166. https://doi.org/10.1200/JCO.2009.26.1610