title: Factors that influence health-related quality of life in newly diagnosed patients with multiple myeloma aged ≥ 65 years treated with melphalan, prednisone and lenalidomide followed by lenalidomide maintenance: results of a randomized trial.
abstract: In the MM-015 trial, melphalan-prednisone-lenalidomide followed by lenalidomide maintenance (MPR-R) significantly prolonged progression-free survival versus melphalan-prednisone (MP) in newly diagnosed patients with multiple myeloma aged ≥ 65 years. Health-related quality of life (HRQoL), a secondary endpoint of MM-015, was also improved with MPR-R. This sub-analysis evaluated the impact of individual predictive factors on HRQoL. Patients completed HRQoL questionnaires at baseline, every third cycle and at progressive disease (PD)/treatment discontinuation. In a mixed-effects model female gender, advanced age and PD negatively affected HRQoL while better treatment responses showed positive effects. Compared to PD, HRQoL during MPR-R treatment was statistically significantly better in two of six preselected domains both of which were also clinically meaningful. HRQoL scores at end of treatment were all either improved or not statistically significantly different versus baseline. In conclusion, continuous treatment with MPR-R, which delays PD, appears to be associated with clinically meaningful improvements in HRQoL.
authors.affiliation: University of Athens School of Medicine , Alexandra Hospital, Athens , Greece.
authors.forename: Meletios A
authors.initials: MA
authors.lastname: Dimopoulos
authors.forename: Antonio
authors.initials: A
authors.lastname: Palumbo
authors.forename: Roman
authors.initials: R
authors.lastname: Hajek
authors.forename: Martin
authors.initials: M
authors.lastname: Kropff
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Petrucci
authors.forename: Philip
authors.initials: P
authors.lastname: Lewis
authors.forename: Stefanie
authors.initials: S
authors.lastname: Millar
authors.forename: Jingshan
authors.initials: J
authors.lastname: Zhang
authors.forename: Jay
authors.initials: J
authors.lastname: Mei
authors.forename: Michel
authors.initials: M
authors.lastname: Delforge
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy; D000077269:Lenalidomide; D060046:Maintenance Chemotherapy; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D009101:Multiple Myeloma / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D009367:Neoplasm Staging; D011241:Prednisone / Q000008:administration & dosage; D011788:Quality of Life; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D000077269:Lenalidomide; D008558:Melphalan; D011241:Prednisone
keywords: Health-related quality of life (HRQoL); QLQ-C30; QLQ-MY20; lenalidomide; minimal important difference (MID); multiple myeloma