title: Lenalidomide is effective as salvage therapy in refractory or relapsed multiple myeloma: analysis of the Spanish Compassionate Use Registry in advanced patients.
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.
authors.affiliation: Department of Hematology, Hospital Universitario de la Princesa, C/Diego de León, 62, 28006, Madrid, Spain. adrian.alegre@telefonica.net.
authors.forename: Adrián
authors.initials: A
authors.lastname: Alegre
authors.affiliation: Department of Hematology, Hospital Universitario de la Princesa, C/Diego de León, 62, 28006, Madrid, Spain.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Aguado
authors.affiliation: Hospital Miguel Servet, Saragossa, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Giraldo
authors.affiliation: Hospital Virgen del Rocío, Seville, Spain.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Ríos
authors.affiliation: Hospital de Cruces, Barakaldo, Spain.
authors.forename: Araceli
authors.initials: A
authors.lastname: Cánovas
authors.affiliation: Complejo Hospitalario Universitario de Albacete, Albacete, Spain.
authors.forename: Ángela
authors.initials: Á
authors.lastname: Ibáñez
authors.affiliation: Hospital General de Elda, Elda, Spain.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Castillo
authors.affiliation: Hospital Universitario de Canarias, Tenerife, Spain.
authors.forename: Miguel T
authors.initials: MT
authors.lastname: Hernández
authors.affiliation: Hospital Germans Trias i Pujol, Badalona, Spain.
authors.forename: Albert
authors.initials: A
authors.lastname: Oriol
authors.affiliation: Hospital Clínico Universitario Lozano Blesa, Saragossa, Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Palomera
authors.affiliation: Hospital Juan Ramón Jiménez, Huelva, Spain.
authors.forename: Juan-N
authors.initials: JN
authors.lastname: Rodríguez
authors.affiliation: Department of Hematology, Hospital Universitario de la Princesa, C/Diego de León, 62, 28006, Madrid, Spain.
authors.forename: Flor-L
authors.initials: FL
authors.lastname: García
authors.affiliation: Hospital General de Lanzarote, Gran Canaria, Spain.
authors.forename: José M
authors.initials: JM
authors.lastname: Calvo
authors.affiliation: Hospital Universitario Quirón, Madrid, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Martínez-Chamorro
authors.affiliation: Hospital Universitario Doce de Octubre, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: de la Serna
authors.affiliation: Hospital Universitario Doce de Octubre, Madrid, Spain.
authors.forename: Juan-J
authors.initials: JJ
authors.lastname: Lahuerta
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D057176:Compassionate Use Trials; D003430:Cross-Sectional Studies; D003907:Dexamethasone / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality*; D012008:Recurrence; D012042:Registries; D012189:Retrospective Studies; D016879:Salvage Therapy / Q000379:methods*; D013030:Spain; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D000970:Antineoplastic Agents; D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide