Health-related quality of life results from the IFM 2009 trial: treatment with lenalidomide, bortezomib, and dexamethasone in transplant-eligible patients with newly diagnosed multiple myeloma

Abstract

The Intergroupe Francophone du Myelome 2009 trial (NCT01191060) assessed health-related quality of life (HRQoL) in patients with newly diagnosed multiple myeloma (NDMM) receiving lenalidomide/bortezomib/dexamethasone (RVd) induction therapy followed by consolidation therapy with either autologous stem cell transplantation (ASCT) plus RVd (RVd-ASCT) or RVd-alone; both groups then received lenalidomide maintenance therapy for 1 year. Global HRQoL, physical functioning, and role functioning scores significantly improved for both cohorts from baseline to the end of consolidation and were sustained during maintenance and follow-up, with clinically meaningful changes (RVd-alone: p = .0002; RVd-ASCT: p < .001). Similarly, both groups showed clinically meaningful improvements from baseline in fatigue, pain, and disease symptom scores. Side effects of treatment scores remained stable. In the RVd-ASCT group, there was transient worsening in HRQoL immediately after ASCT. These findings suggest that the clinical improvements observed with RVd-based treatment are accompanied by overall improvements in HRQoL for patients with NDMM.

Keywords:

• Quality of life
• multiple myeloma
• autologous stem cell transplantation
• lenalidomide
• bortezomib
• dexamethasone

Acknowledgments

The authors would like to thank the study investigators, participating sites, patients, nurses, and personnel who were involved in the study. The IFM 2009 study was supported by the French Programme Hospitalier de Recherche Clinique, by the French National Research Agency (ANR-11-PHUC-001-CAPTOR project), and by a grant from Celgene Corporation, and Janssen (ClinicalTrials.gov number, NCT01191060). The authors received writing and editorial assistance in the preparation of this manuscript funded by Bristol-Myers Squibb. Writing assistance was provided by Evidera (Kim Poinsett-Holmes, PharmD, and Saurabh Aggarwal, PhD), and editorial assistance by Excerpta Medica (Rosie Morland, PhD) and AccuScript Consultancy (Rowena Hughes, PhD).

Disclosure statement

The authors are fully responsible for all content and editorial decisions for this manuscript. Dr. Dhanasiri reports other from Celgene, A Bristol-Myers Squibb Company, during the conduct of the study.

Data availability statement

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Additional information

Funding

This work was supported by Celgene, a wholly owned subsidiary of Bristol-Myers Squibb and Agence Nationale de la Recherche.