title: Lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance, improves health-related quality of life in newly diagnosed multiple myeloma patients aged 65 years or older: results of a randomized phase III trial.
abstract: The MM-015 trial assessed the effect of lenalidomide-based therapy on health-related quality of life. Patients (n=459) with newly diagnosed multiple myeloma aged 65 years or over were randomized 1:1:1 to nine 4-week cycles of lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance; or lenalidomide, melphalan, and prednisone, or melphalan and prednisone, with no maintenance therapy. Patients completed health-related quality of life questionnaires at baseline, after every third treatment cycle, and at treatment end. Health-related quality of life improved in all treatment groups during induction therapy. Patients receiving lenalidomide maintenance had the most pronounced improvements, Global Health Status/Quality of Life (P<0.05), Physical Functioning (P<0.01), and Side Effects of Treatment (P<0.05) out of 6 pre-selected health-related quality of life domains. More patients receiving lenalidomide maintenance achieved minimal important differences (P<0.05 for Physical Functioning). Therefore, lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance, improves health-related quality of life in patients with newly diagnosed multiple myeloma. (Clinicaltrials.gov identifier NCT00405756).
authors.affiliation: University of Athens School of Medicine, Alexandra Hospital, Athens, Greece. mdimop@med.uoa.gr
authors.forename: Meletios A
authors.initials: MA
authors.lastname: Dimopoulos
authors.forename: Michel
authors.initials: M
authors.lastname: Delforge
authors.forename: Roman
authors.initials: R
authors.lastname: Hájek
authors.forename: Martin
authors.initials: M
authors.lastname: Kropff
authors.forename: Maria T
authors.initials: MT
authors.lastname: Petrucci
authors.forename: Philip
authors.initials: P
authors.lastname: Lewis
authors.forename: Annabel
authors.initials: A
authors.lastname: Nixon
authors.forename: Jingshan
authors.initials: J
authors.lastname: Zhang
authors.forename: Jay
authors.initials: J
authors.lastname: Mei
authors.forename: Antonio
authors.initials: A
authors.lastname: Palumbo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D060828:Induction Chemotherapy; D000077269:Lenalidomide; D060046:Maintenance Chemotherapy; D008558:Melphalan / Q000008:administration & dosage; D009101:Multiple Myeloma / Q000188:drug therapy*; D011241:Prednisone / Q000008:administration & dosage; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D013792:Thalidomide; D000077269:Lenalidomide; D008558:Melphalan; D011241:Prednisone