title: Efficacy, safety and quality-of-life associated with lenalidomide plus dexamethasone for the treatment of relapsed or refractory multiple myeloma: the Spanish experience.
abstract: Here we report the efficacy, safety and health-related quality-of-life (HRQoL) associated with long-term lenalidomide and dexamethasone (Len + Dex) treatment in patients with relapsed or refractory multiple myeloma (RRMM) enrolled in the Spanish cohort of the MM-018 study. In this open-label, multicenter, single-arm expanded access study, 63 patients received Len + Dex until disease progression. The overall response rate was 78%, with 21% of the patients achieving a complete response. The quality of response improved with continuous treatment. The median duration of response was 18.4 months. Median time-to-progression and progression-free survival was 13.3 months for both; median overall survival was not reached. Len + Dex had a manageable safety profile consistent with previously reported phase III studies. HRQoL assessments (n = 42) at baseline and 6 months using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ MY-20 questionnaires revealed that patients with RRMM treated with long-term lenalidomide reported clinically relevant improvements in certain QoL and symptoms scores regardless of treatment response (ClinicalTrials.gov: NCT00420849).
authors.affiliation: Hematology Department, Hospital Universitario de La Princesa, Madrid, Spain. adrian.alegre@telefonica.net
authors.forename: Adrian
authors.initials: A
authors.lastname: Alegre
authors.forename: Albert
authors.initials: A
authors.lastname: Oriol-Rocafiguera
authors.forename: Jose
authors.initials: J
authors.lastname: Garcia-Larana
authors.forename: Maria-Victoria
authors.initials: MV
authors.lastname: Mateos
authors.forename: Anna
authors.initials: A
authors.lastname: Sureda
authors.forename: Carmen
authors.initials: C
authors.lastname: Martinez-Chamorro
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Cibeira
authors.forename: Beatriz
authors.initials: B
authors.lastname: Aguado
authors.forename: Robert
authors.initials: R
authors.lastname: Knight
authors.forename: Barbara
authors.initials: B
authors.lastname: Rosettani
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D018450:Disease Progression; D018572:Disease-Free Survival; D019008:Drug Resistance, Neoplasm / Q000187:drug effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000473:pathology; D009503:Neutropenia / Q000139:chemically induced; D011788:Quality of Life; D012008:Recurrence; D013030:Spain; D011795:Surveys and Questionnaires; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D013921:Thrombocytopenia / Q000139:chemically induced; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide