Autologous transplantation and maintenance therapy in multiple myeloma

A. Palumbo*, F. Cavallo, F. Gay, F. Di Raimondo, D. B. Yehuda, M. T. Petrucci, S. Pezzatti, T. Caravita, C. Cerrato, E. Ribakovsky, M. Genuardi, A. Cafro, M. Marcatti, L. Catalano, M. Offidani, A. M. Carella, E. Zamagni, F. Patriarca, P. Musto, A. EvangelistaG. Ciccone, P. Omedé, C. Crippa, P. Corradini, A. Nagler, M. Boccadoro, M. Cavo

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

615 Scopus citations

Abstract

Background: This open-label, randomized, phase 3 study compared melphalan at a dose of 200 mg per square meter of body-surface area plus autologous stem-cell transplantation with melphalan-prednisone-lenalidomide (MPR) and compared lenalidomide maintenance therapy with no maintenance therapy in patients with newly diagnosed multiple myeloma. Methods: We randomly assigned 273 patients 65 years of age or younger to high-dose melphalan plus stem-cell transplantation or MPR consolidation therapy after induction, and 251 patients to lenalidomide maintenance therapy or no maintenance therapy. The primary end point was progression-free survival. Results: The median follow-up period was 51.2 months. Both progression-free and overall survival were significantly longer with high-dose melphalan plus stem-cell transplantation than with MPR (median progression-free survival, 43.0 months vs. 22.4 months; hazard ratio for progression or death, 0.44; 95% confidence interval [CI], 0.32 to 0.61; P<0.001; and 4-year overall survival, 81.6% vs. 65.3%; hazard ratio for death, 0.55; 95% CI, 0.32 to 0.93; P = 0.02). Median progression-free survival was significantly longer with lenalidomide maintenance than with no maintenance (41.9 months vs. 21.6 months; hazard ratio for progression or death, 0.47; 95% CI, 0.33 to 0.65; P<0.001), but 3-year overall survival was not significantly prolonged (88.0% vs. 79.2%; hazard ratio for death, 0.64; 95% CI, 0.36 to 1.15; P = 0.14). Grade 3 or 4 neutropenia was significantly more frequent with high-dose melphalan than with MPR (94.3% vs. 51.5%), as were gastrointestinal adverse events (18.4% vs. 0%) and infections (16.3% vs. 0.8%); neutropenia and dermatologic toxic effects were more frequent with lenalidomide maintenance than with no maintenance (23.3% vs. 0% and 4.3% vs. 0%, respectively). Conclusions: Consolidation therapy with high-dose melphalan plus stem-cell transplantation, as compared with MPR, significantly prolonged progression-free and overall survival among patients with multiple myeloma who were 65 years of age or younger. Lenalidomide maintenance, as compared with no maintenance, significantly prolonged progression-free survival.

Original languageAmerican English
Pages (from-to)895-905
Number of pages11
JournalNew England Journal of Medicine
Volume371
Issue number10
DOIs
StatePublished - 4 Sep 2014
Externally publishedYes

Bibliographical note

Publisher Copyright:
Copyright © 2014 Massachusetts Medical Society.

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