Bortezomib-thalidomide-dexamethasone is superior to thalidomide- dexamethasone as consolidation therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma

Michele Cavo, Lucia Pantani, Maria Teresa Petrucci, Francesca Patriarca, Elena Zamagni, Daniela Donnarumma, Claudia Crippa, Mario Boccadoro, Giulia Perrone, Antonietta Falcone, Chiara Nozzoli, Renato Zambello, Luciano Masini, Anna Furlan, Annamaria Brioli, Daniele Derudas, Stelvio Ballanti, Maria Laura Dessanti, Valerio De Stefano, Angelo Michele CarellaMagda Marcatti, Andrea Nozza, Felicetto Ferrara, Vincenzo Callea, Catello Califano, Annalisa Pezzi, Anna Baraldi, Mariella Grasso, Pellegrino Musto, Antonio Palumbo

Research output: Contribution to journalArticle

Abstract

In a randomized, phase 3 study, superior complete/near-complete response (CR/nCR) rates and extended progression-free survival were demonstrated with bortezomib-thalidomide-dexamethasone (VTD) versus thalidomide-dexamethasone (TD) as induction therapy before, and consolidation after, double autologous stem cell transplantation for newly diagnosed myeloma patients (intention-to-treat analysis; VTD, n = 236; TD, n = 238). This per-protocol analysis (VTD, n = 160; TD, n = 161) specifically assessed the efficacy and safety of consolidation with VTD or TD. Before starting consolidation, CR/nCR rates were not significantly different in the VTD (63.1%) and TD arms (54.7%). After consolidation, CR (60.6% vs 46.6%) and CR/nCR (73.1% vs 60.9%) rates were significantly higher for VTD-treated versus TD-treated patients. VTD consolidation significantly increased CR and CR/nCR rates, but TD did not (McNemar test). With a median follow-up of 30.4 months from start of consolidation, 3-year progression-free survival was significantly longer for the VTD group (60% vs 48% for TD). Grade 2 or 3 peripheral neuropathy (8.1% vs 2.4%) was more frequent with VTD (grade 3, 0.6%) versus TD consolidation. The superior efficacy of VTD versus TD as induction was retained despite readministration as consolidation therapy after double autologous transplantation. VTD consolidation therapy significantly contributed to improved clinical outcomes observed for patients randomly assigned to the VTD arm of the study. The study is registered at www.clinicaltrials.gov as #NCT01134484.

Original languageEnglish
Pages (from-to)9-19
Number of pages11
JournalBlood
Volume120
Issue number1
DOIs
Publication statusPublished - Jul 5 2012

ASJC Scopus subject areas

  • Hematology
  • Biochemistry
  • Cell Biology
  • Immunology

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    Cavo, M., Pantani, L., Petrucci, M. T., Patriarca, F., Zamagni, E., Donnarumma, D., Crippa, C., Boccadoro, M., Perrone, G., Falcone, A., Nozzoli, C., Zambello, R., Masini, L., Furlan, A., Brioli, A., Derudas, D., Ballanti, S., Dessanti, M. L., De Stefano, V., ... Palumbo, A. (2012). Bortezomib-thalidomide-dexamethasone is superior to thalidomide- dexamethasone as consolidation therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma. Blood, 120(1), 9-19. https://doi.org/10.1182/blood-2012-02-408898