Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: Lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide

Michel Delforge, Leonard Minuk, Jean Claude Eisenmann, Bertrand Arnulf, Letizia Canepa, Alberto Fragasso, Serge Leyvraz, Christian Langer, Yousef Ezaydi, Dan T. Vogl, Pilar Giraldo-Castellano, Sung Soo Yoon, Charles Zarnitsky, Martine Escoffre-Barbe, Bernard Lemieux, Kevin Song, Nizar Jacques Bahlis, Shien Guo, Mara Silva Monzini, Annette Ervin-HaynesVanessa Houck, Thierry Facon

Research output: Contribution to journalArticlepeer-review

Abstract

We compared the health-related quality-of-life of patients with newly diagnosed multiple myeloma aged over 65 years or transplant-ineligible in the pivotal, phase III FIRST trial. Patients received: i) continuous lenalidomide and low-dose dexamethasone until disease progression; ii) fixed cycles of lenalidomide and low-dose dexamethasone for 18 months; or iii) fixed cycles of melphalan, prednisone, thalidomide for 18 months. Data were collected using the validated questionnaires (QLQ-MY20, QLQ-C30, and EQ-5D). The analysis focused on the EQ-5D utility value and six domains pre-selected for their perceived clinical relevance. Lenalidomide and low-dose dexamethasone, and melphalan, prednisone, thalidomide improved patients’ health-related quality-of-life from baseline over the duration of the study across all pre-selected domains of the QLQ-C30 and EQ-5D. In the QLQ-MY20, lenalidomide and low-dose dexamethasone demonstrated a significantly greater reduction in the Disease Symptoms domain compared with melphalan, prednisone, thalidomide at Month 3, and significantly lower scores for QLQMY20 Side Effects of Treatment at all post-baseline assessments except Month 18. Linear mixed-model repeatedmeasures analyses confirmed the results observed in the cross-sectional analysis. Continuous lenalidomide and low-dose dexamethasone delays disease progression versusmelphalan, prednisone, thalidomide and has been associated with a clinically meaningful improvement in health-related quality-of-life. These results further establish continuous lenalidomide and low-dose dexamethasone as a new standard of care for initial therapy of myeloma by demonstrating superior health-related quality-of-life during treatment, compared with melphalan, prednisone, thalidomide.

Original languageEnglish
Pages (from-to)826-833
Number of pages8
JournalHaematologica
Volume100
Issue number6
DOIs
Publication statusPublished - 2015

ASJC Scopus subject areas

  • Hematology

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