Lenalidomide-prednisone induction followed by lenalidomide-melphalan- prednisone consolidation and lenalidomide-prednisone maintenance in newly diagnosed elderly unfit myeloma patients

P. Falco, F. Cavallo, A. Larocca, D. Rossi, T. Guglielmelli, A. Rocci, M. Grasso, M. L M Siez, L. De Paoli, S. Oliva, S. Molica, R. Mina, F. Gay, G. Benevolo, P. Musto, P. Omedè, R. Freilone, S. Bringhen, A. M. Carella, G. GaidanoM. Boccadoro, A. Palumbo

Research output: Contribution to journalArticlepeer-review

Abstract

This multicenter phase II trial evaluated the safety and efficacy of lenalidomide-prednisone (RP) induction, followed by lenalidomide-melphalan- prednisone (MPR) consolidation and RP maintenance in elderly unfit newly diagnosed myeloma patients. Patients received four 28-day RP induction courses (lenalidomide 25 mg/day on days 1-21 and prednisone 50 mg three times/week), followed by six 28-day MPR consolidation cycles (melphalan 2 mg, prednisone 50 mg three times/week and lenalidomide 10-15 mg/day on days 1-21), and maintenance with lenalidomide (10 mg/day on days 1-21 every 28 days) plus prednisone (25 mg three times/week). Forty-six patients were enrolled. Median age was 75 years, 59% of patients had at least one comorbidity and 35% at least two. Partial response rate was 80%, including 29% very good partial response. Median time to progression was 19.6 months, median progression-free survival was 18.4 months and 2-year overall survival was 80%. At the tolerated consolidation dose (melphalan 25 mg/month and lenalidomide 10 mg/day), the most frequent grade 3 adverse events were neutropenia (36.4%), anemia (12.1%), cutaneous reactions (18.2%) and infections (12.1%). Grade 4 neutropenia occurred in 12.1% of patients. In conclusion, RP induction followed by MPR consolidation and RP maintenance showed a manageable safety profile, and reduced the risk of severe hematological toxicity in unfit elderly myeloma patients.

Original languageEnglish
Pages (from-to)695-701
Number of pages7
JournalLeukemia
Volume27
Issue number3
DOIs
Publication statusPublished - Mar 2013

Keywords

  • elderly patients
  • lenalidomide
  • melphalan
  • myeloma
  • unfit patients

ASJC Scopus subject areas

  • Hematology
  • Cancer Research
  • Anesthesiology and Pain Medicine

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