PURPOSE:Thalidomide is effective in the treatment of newly diagnosed and relapsed/refractory multiple myeloma (MM). However, the role of thalidomide in the post-autologous stem cell transplantation (ASCT) context remains unclear. This study assessed whether the addition of thalidomide consolidation following ASCT would improve the durability of responses achieved and overall survival. PATIENTS AND METHODS: Between January 2002 and March 2005, 269 patients with newly diagnosed MM who achieved disease stabilization or better withconventional induction chemotherapy received a single high-dose melphalan conditioned ASCT. Post-ASCT, 129 patients were randomly assigned to receive indefinite prednisolone maintenance therapy (control group) and 114 to receive the same in addition to 12 months of thalidomide consolidation (thalidomide group). The primary study end points were progression-free survival (PFS) and overall survival (OS). The secondary end point was tolerability. RESULTS: After a median follow-up of 3 years, the postrandomization 3-year PFS rates were 42% and 23% (P < .001; hazard ratio [HR], 0.5; 95% CI, 0.35 to 0.71) and the OS rates were 86% and 75% (P = .004; HR, 0.41; 95% CI, 0.22 to 0.76) in the thalidomide and control groups, respectively. There was no difference in survival between groups 12 months after disease progression (79% v 77%; P = .237). Neurological toxicities were more common in the thalidomide arm but there were no differences between arms for thromboembolic events. CONCLUSION: Consolidation therapy with 12 months of thalidomide combined with prednisolone prolongs survival when used after a single high-dose therapy supported ASCT in patients with newly diagnosed MM. Furthermore, thalidomide consolidation therapy did not adversely impact on survival in the subsequent salvage setting.
RCT Entities:
PURPOSE:Thalidomide is effective in the treatment of newly diagnosed and relapsed/refractory multiple myeloma (MM). However, the role of thalidomide in the post-autologous stem cell transplantation (ASCT) context remains unclear. This study assessed whether the addition of thalidomide consolidation following ASCT would improve the durability of responses achieved and overall survival. PATIENTS AND METHODS: Between January 2002 and March 2005, 269 patients with newly diagnosed MM who achieved disease stabilization or better with conventional induction chemotherapy received a single high-dose melphalan conditioned ASCT. Post-ASCT, 129 patients were randomly assigned to receive indefinite prednisolone maintenance therapy (control group) and 114 to receive the same in addition to 12 months of thalidomide consolidation (thalidomide group). The primary study end points were progression-free survival (PFS) and overall survival (OS). The secondary end point was tolerability. RESULTS: After a median follow-up of 3 years, the postrandomization 3-year PFS rates were 42% and 23% (P < .001; hazard ratio [HR], 0.5; 95% CI, 0.35 to 0.71) and the OS rates were 86% and 75% (P = .004; HR, 0.41; 95% CI, 0.22 to 0.76) in the thalidomide and control groups, respectively. There was no difference in survival between groups 12 months after disease progression (79% v 77%; P = .237). Neurological toxicities were more common in the thalidomide arm but there were no differences between arms for thromboembolic events. CONCLUSION: Consolidation therapy with 12 months of thalidomide combined with prednisolone prolongs survival when used after a single high-dose therapy supported ASCT in patients with newly diagnosed MM. Furthermore, thalidomide consolidation therapy did not adversely impact on survival in the subsequent salvage setting.
Authors: Heinz Ludwig; Brian G M Durie; Philip McCarthy; Antonio Palumbo; Jésus San Miguel; Bart Barlogie; Gareth Morgan; Pieter Sonneveld; Andrew Spencer; Kenneth C Andersen; Thierry Facon; Keith A Stewart; Hermann Einsele; Maria-Victoria Mateos; Pierre Wijermans; Anders Waage; Meral Beksac; Paul G Richardson; Cyrille Hulin; Ruben Niesvizky; Henk Lokhorst; Ola Landgren; P Leif Bergsagel; Robert Orlowski; Axel Hinke; Michele Cavo; Michel Attal Journal: Blood Date: 2012-01-23 Impact factor: 22.113
Authors: Shaji K Kumar; Joseph R Mikhael; Francis K Buadi; David Dingli; Angela Dispenzieri; Rafael Fonseca; Morie A Gertz; Philip R Greipp; Suzanne R Hayman; Robert A Kyle; Martha Q Lacy; John A Lust; Craig B Reeder; Vivek Roy; Stephen J Russell; Kristen E Detweiler Short; A Keith Stewart; Thomas E Witzig; Steven R Zeldenrust; Robert J Dalton; S Vincent Rajkumar; P Leif Bergsagel Journal: Mayo Clin Proc Date: 2009-12 Impact factor: 7.616
Authors: Bart Barlogie; Michel Attal; John Crowley; Frits van Rhee; Jackie Szymonifka; Philippe Moreau; Brian G M Durie; Jean-Luc Harousseau Journal: J Clin Oncol Date: 2010-01-19 Impact factor: 44.544