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Myeloma

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

Leukemia volume 27, pages 695–701 (2013)Cite this article

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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.

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Acknowledgements

We thank the patients who took part in the study, the Rete Oncologica del Piemonte e della Valle d’Aosta, the nurses Manuela Grasso and Loredana Puccio, the data managers Federica Leotta and Elena Tigano and the editorial assistant Giorgio Schirripa.

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Authors and Affiliations

  1. Division of Transfusional Medicine and Hematology, Cirié, Italy

    P Falco & R Freilone

  2. Division of Hematology, Myeloma Unit, University of Torino, Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino, Italy

    F Cavallo, A Larocca, A Rocci, S Oliva, R Mina, F Gay, P Omedè, S Bringhen, M Boccadoro & A Palumbo

  3. Division of Hematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont, Novara, Italy

    D Rossi, L De Paoli & G Gaidano

  4. Unit Of Hematology, S Luigi Gonzaga Hospital, Orbassano, Italy

    T Guglielmelli

  5. Department of Hematology, S Croce e Carle Hospital, Cuneo, Italy

    M Grasso

  6. Department of Internal Medicine, SOS Hematology, Infermi Hospital, Biella, Italy

    M L M Siez

  7. Department of Hematology-Oncology, A.O. Pugliese-Ciaccio, Catanzaro, Italy

    S Molica

  8. Division of Haematology 2, ASO San Giovanni Battista, Torino, Italy

    G Benevolo

  9. Unit of Hematology and Stem Cell Transplantation, IRCCS-CROB, Centro di Riferimento Oncologico, della Basilicata, Rionero in Vulture, Italy,

    P Musto

  10. Division of Hematology, S Martino Hospital, Genova, Italy

    A M Carella

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  1. P Falco
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  9. L De Paoli
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  13. F Gay
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  15. P Musto
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  16. P Omedè
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  18. S Bringhen
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  19. A M Carella
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  22. A Palumbo
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Correspondence to A Palumbo.

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Competing interests

PF has received honoraria from Celgene, Janssen-Cilag and Novartis; FC has received honoraria from Celgene, Janssen-Cilag, Onyx, and served on the advisory committee for Celgene; AL has received honoraria from Celgene and Janssen-Cilag; TG has received honoraria from Celgene and Janssen-Cilag; PM has received honoraria from Celgene; MB has received research funding from and served on the advisory board for Celgene and Janssen-Cilag; AP has received honoraria from Celgene, Janssen-Cilag, Bristol-Myers Squibb, Millenium, Merck, Onyx, and served on the advisory board for Celgene and Janssen-Cilag. The remaining authors declare no conflict of interest.

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Falco, P., Cavallo, F., Larocca, A. et al. Lenalidomide−prednisone induction followed by lenalidomide−melphalan−prednisone consolidation and lenalidomide−prednisone maintenance in newly diagnosed elderly unfit myeloma patients. Leukemia 27, 695–701 (2013). https://doi.org/10.1038/leu.2012.271

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