• Michel Attal, Valerie Lauwers-Cances, Cyrille Hulin, Xavier Leleu, Denis Caillot, Martine Escoffre, Bertrand Arnulf, Margaret Macro, Karim Belhadj, Laurent Garderet, Murielle Roussel, Catherine Payen, Claire Mathiot, Jean P Fermand, Nathalie Meuleman, Sandrine Rollet, Michelle E Maglio, Andrea A Zeytoonjian, Edie A Weller, Nikhil Munshi, Kenneth C Anderson, Paul G Richardson, Thierry Facon, Hervé Avet-Loiseau, Jean-Luc Harousseau, Philippe Moreau, and IFM 2009 Study.
• From the Institut Universitaire du Cancer de Toulouse-Oncopole (M.A., M.R., C.P., S.R., H.A.-L.) and Service d'Epidémiologie, Centre Hospitalier et Universitaire de Toulouse (V.L.-C.), Toulouse, Hôpital Haut-Lévêque, Bordeaux Pessac (C.H.), Centre Hospitalier et Universitaire la Miletrie, Poitiers (X.L.), Centre Hospitalier Le Bocage, Dijon (D.C.), Centre Hospitalier et Universitaire de Rennes, Rennes (M.E.), Hôpital St.-Louis (B.A., J.P.F.), Centre Hospitalier Universitaire, Hôpital St.-Antoine (L.G.), Institut Curie (C.M.), and Haute Autorité de Santé (J.-L.H.), Paris, Institut d'Hématologie de Basse Normandie, Centre Hospitalier et Universitaire de Caen, Caen (M.M.), Centre Hospitalier et Universitaire Henri Mondor, Creteil (K.B.), Hôpital Claude Huriez, Lille (T.F.), and Hôtel Dieu, Nantes (P.M.) - all in France; Institut Jules Bordet, Brussels (N. Meuleman); and Dana-Farber Cancer Institute, Boston (M.E.M., A.A.Z., E.A.W., N. Munshi, K.C.A., P.G.R.).
• N. Engl. J. Med. 2017 Apr 6; 376 (14): 1311-1320.

BackgroundHigh-dose chemotherapy plus autologous stem-cell transplantation has been the standard treatment for newly diagnosed multiple myeloma in adults up to 65 years of age. However, promising data on the use of combination therapy with lenalidomide, bortezomib, and dexamethasone (RVD) in this population have raised questions about the role and timing of transplantation.MethodsWe randomly assigned 700 patients with multiple myeloma to receive induction therapy with three cycles of RVD and then consolidation therapy with either five additional cycles of RVD (350 patients) or high-dose melphalan plus stem-cell transplantation followed by two additional cycles of RVD (350 patients). Patients in both groups received maintenance therapy with lenalidomide for 1 year. The primary end point was progression-free survival.ResultsMedian progression-free survival was significantly longer in the group that underwent transplantation than in the group that received RVD alone (50 months vs. 36 months; adjusted hazard ratio for disease progression or death, 0.65; P<0.001). This benefit was observed across all patient subgroups, including those stratified according to International Staging System stage and cytogenetic risk. The percentage of patients with a complete response was higher in the transplantation group than in the RVD-alone group (59% vs. 48%, P=0.03), as was the percentage of patients in whom minimal residual disease was not detected (79% vs. 65%, P<0.001). Overall survival at 4 years did not differ significantly between the transplantation group and the RVD-alone group (81% and 82%, respectively). The rate of grade 3 or 4 neutropenia was significantly higher in the transplantation group than in the RVD-alone group (92% vs. 47%), as were the rates of grade 3 or 4 gastrointestinal disorders (28% vs. 7%) and infections (20% vs. 9%). No significant between-group differences were observed in the rates of treatment-related deaths, second primary cancers, thromboembolic events, and peripheral neuropathy.ConclusionsAmong adults with multiple myeloma, RVD therapy plus transplantation was associated with significantly longer progression-free survival than RVD therapy alone, but overall survival did not differ significantly between the two approaches. (Supported by Celgene and others; IFM 2009 Study ClinicalTrials.gov number, NCT01191060 .).

29 keywords...

hide…