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Lenalidomide in combination with dexamethasone improves survival and time-to-progression in patients ≥65 years old with relapsed or refractory multiple myeloma

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Abstract

Two pivotal, phase III, randomised, placebo-controlled, registration trials (MM-009 and MM-010) showed that lenalidomide plus dexamethasone was more effective than placebo plus dexamethasone in the treatment of patients with relapsed or refractory multiple myeloma. This pooled, retrospective subanalysis of MM-009 and MM-010 analysed outcomes according to patient age. A total of 704 patients (390 aged <65 years, 232 aged 65–74 years, and 82 aged ≥75 years) received lenalidomide or placebo, both in combination with dexamethasone. The overall response rate (ORR) was significantly higher in patients treated with lenalidomide plus dexamethasone versus placebo plus dexamethasone in all age groups (P < 0.0001 for all). Median progression-free survival (PFS) and median time-to-progression (TTP) were similar, and both were significantly longer with lenalidomide plus dexamethasone in all age groups (P < 0.001 for all). Median overall survival (OS) favoured lenalidomide plus dexamethasone in all age groups, although the difference was not statistically significant. Adverse events of anaemia, febrile neutropenia, deep-vein thrombosis, neuropathy, and gastrointestinal disorders increased with age. Lenalidomide combined with dexamethasone improved the ORR and prolonged PFS, TTP, and OS compared with placebo plus dexamethasone, irrespective of age. This finding was consistent with the overall MM-009 and MM-010 populations.

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Acknowledgments

The authors received editorial support from Excerpta Medica in the preparation of this manuscript, funded by Celgene Corporation.

Conflict of interst

A.A.C-K. and M.A.D. have received consulting and lecture fees from Celgene. S.L. and A.H. have received consulting fees from Celgene. D.W. has received grant support and lecture fees from Celgene. I.B. has received grant support and consulting and lecture fees from Celgene. A.S.S. and R.K. are employees of Celgene. R.F. has no disclosures.

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Authors and Affiliations

  1. Department of Medicine, Roswell Park Cancer Institute Buffalo, Elm and Carlton Street, Buffalo, NY, 14263, USA

    Asher A. Chanan-Khan

  2. Emory Winship Cancer Institute, Atlanta, GA, USA

    Sagar Lonial

  3. M.D. Anderson Cancer Center, Houston, TX, USA

    Donna Weber

  4. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA

    Ivan Borrello

  5. Department of Cellular Biotechnologies and Hematology, Sapienza University of Rome, Rome, Italy

    Robin Foà

  6. Department of Hematology and Transplantology, Medical University of Gdańsk, Gdańsk, Poland

    Andrzej Hellmann

  7. The University of Athens School of Medicine, Athens, Greece

    Meletios Dimopoulos

  8. Celgene Corporation, Summit, NJ, USA

    Arlene S. Swern & Robert Knight

Authors
  1. Asher A. Chanan-Khan
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  2. Sagar Lonial
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  3. Donna Weber
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  4. Ivan Borrello
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  5. Robin Foà
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  6. Andrzej Hellmann
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  7. Meletios Dimopoulos
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  8. Arlene S. Swern
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  9. Robert Knight
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Corresponding author

Correspondence to Asher A. Chanan-Khan.

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Chanan-Khan, A.A., Lonial, S., Weber, D. et al. Lenalidomide in combination with dexamethasone improves survival and time-to-progression in patients ≥65 years old with relapsed or refractory multiple myeloma. Int J Hematol 96, 254–262 (2012). https://doi.org/10.1007/s12185-012-1125-7

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  • DOI: https://doi.org/10.1007/s12185-012-1125-7

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