International Journal of Hematology

, Volume 93, Issue 3, pp 351–360

Lenalidomide is effective as salvage therapy in refractory or relapsed multiple myeloma: analysis of the Spanish Compassionate Use Registry in advanced patients

  • Adrián Alegre
  • Beatriz Aguado
  • Pilar Giraldo
  • Eduardo Ríos
  • Araceli Cánovas
  • Ángela Ibáñez
  • Inmaculada Castillo
  • Miguel T. Hernández
  • Albert Oriol
  • Luis Palomera
  • Juan-N. Rodríguez
  • Flor-L. García
  • José M. Calvo
  • Carmen Martínez-Chamorro
  • Javier de la Serna
  • Juan-J. Lahuerta
Original Article

DOI: 10.1007/s12185-011-0785-z

Cite this article as:
Alegre, A., Aguado, B., Giraldo, P. et al. Int J Hematol (2011) 93: 351. doi:10.1007/s12185-011-0785-z

Abstract

We evaluated the clinical results of lenalidomide (Len) as a compassionate salvage therapy in refractory/relapsed multiple myeloma (MM) patients. A nationwide multi-centre, retrospective research study was performed to evaluate clinical data from patients with advanced MM for which compassionate use of lenalidomide was requested. The primary endpoints were the overall response rate (ORR) and the time to progression (TTP). Secondary objectives included safety and overall survival (OS) since starting of lenalidomide therapy. Data collected from the Spanish Compassionate Use Registry included 111 patients treated in 2006–2008. The median (range) number of previous treatment lines was 3 (1–8). The median duration of lenalidomide treatment while on study was of 4.9 months (1–18). Dexamethasone was given concomitantly with Len in 89% of patients. The ORR was 66% (4% of patients had stringent complete, 11% complete and 11% very good partial responses). Median TTP and OS were 13.0 and 17.4 months, respectively. The depth of response was significantly associated with a longer OS. Toxicity, mainly myelosuppression, was predictable and manageable with Len dose adjustments and cytokine support. Lenalidomide as salvage compassionate therapy in refractory/relapsed MM showed, in this series of heavily pre-treated patients, similar efficacy to that reported in pivotal clinical trials with acceptable tolerance.

Keywords

LenalidomideMultiple myelomaCompassionate useSalvage therapyPlasmacytoma

Copyright information

© The Japanese Society of Hematology 2011

Authors and Affiliations

  • Adrián Alegre
    • 1
  • Beatriz Aguado
    • 1
  • Pilar Giraldo
    • 2
  • Eduardo Ríos
    • 3
  • Araceli Cánovas
    • 4
  • Ángela Ibáñez
    • 5
  • Inmaculada Castillo
    • 6
  • Miguel T. Hernández
    • 7
  • Albert Oriol
    • 8
  • Luis Palomera
    • 9
  • Juan-N. Rodríguez
    • 10
  • Flor-L. García
    • 1
  • José M. Calvo
    • 11
  • Carmen Martínez-Chamorro
    • 12
  • Javier de la Serna
    • 13
  • Juan-J. Lahuerta
    • 13
  1. 1.Department of HematologyHospital Universitario de la PrincesaMadridSpain
  2. 2.Hospital Miguel ServetSaragossaSpain
  3. 3.Hospital Virgen del RocíoSevilleSpain
  4. 4.Hospital de CrucesBarakaldoSpain
  5. 5.Complejo Hospitalario Universitario de AlbaceteAlbaceteSpain
  6. 6.Hospital General de EldaEldaSpain
  7. 7.Hospital Universitario de CanariasTenerifeSpain
  8. 8.Hospital Germans Trias i PujolBadalonaSpain
  9. 9.Hospital Clínico Universitario Lozano BlesaSaragossaSpain
  10. 10.Hospital Juan Ramón JiménezHuelvaSpain
  11. 11.Hospital General de LanzaroteGran CanariaSpain
  12. 12.Hospital Universitario QuirónMadridSpain
  13. 13.Hospital Universitario Doce de OctubreMadridSpain