Health-related quality of life in transplant ineligible newly diagnosed multiple myeloma patients treated with either thalidomide or lenalidomide-based regimen until progression: a prospective, open-label, multicenter, randomized, phase 3 study.

Abstract

Data on the impact of long term treatment with immunomodulatory drugs (IMiD) on health-related quality of life (HRQoL) is limited. The HOVON-87/NMSG18 study was a randomized, phase 3 study in newly diagnosed transplant ineligible patients with multiple myeloma, comparing melphalan-prednisolone in combination with thalidomide or lenalidomide, followed by maintenance therapy until progression (MPT-T or MPR-R). The EORTC QLQ-C30 and MY20 questionnaires were completed at baseline, after three and nine induction cycles and six and 12 months of maintenance therapy. Linear mixed models and minimal important differences were used for evaluation. 596 patients participated in HRQoL reporting. Patients reported clinically relevant improvement in global quality of life (QoL), future perspective and role and emotional functioning, and less fatigue and pain in both arms. The latter being of large effect size. In general, improvement occurred after 6-12 months of maintenance only and was independent of the World Health Organisation performance at baseline. Patients treated with MPR-R reported clinically relevant worsening of diarrhea, and patients treated with MPT-T reported a higher incidence of neuropathy. Patients who remained on lenalidomide maintenance therapy for at least three months reported clinically meaningful improvement in global QoL and role functioning at six months, remaining stable thereafter. There were no clinically meaningful deteriorations, but patients on thalidomide reported clinically relevant worsening in neuropathy. In general, HRQoL improves both during induction and maintenance therapy with immunomodulatory drugs. The side effect profile of treatment did not negatively affect global QoL, but it was, however, clinically relevant for the patients. (Clinicaltrials.gov identifier: NTR1630).

• Authors: Lene Kongsgaard Nielsen, Claudia Stege, Birgit Lissenberg-Witte, Bronno van der Holt, Ulf-Henrik Mellqvist, Morten Salomo, Gerard Bos, Mark-David Levin, Heleen Visser-Wisselaar, Markus Hansson, Annette van der Velden, Wendy Deenik, Juleon Coenen, Maja Hinge, Saskia Klein, Bea Tanis, Damian Szatkowski, Rolf Brouwer, Matthijs Westerman, Rineke Leys, Harm Sinnige, Einar Haukås, Klaas van der Hem, Marc Durian, Peter Gimsing, Niels van de Donk, Pieter Sonneveld, Anders Waage, Niels Abildgaard, Sonja Zweegman
• Journal: Haematologica (Haematologica) Vol. 105 Issue 6 Pg. 1650-1659 (06 2020) ISSN: 1592-8721 [Electronic] Italy
• PMID: 31515355 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright© 2020 Ferrata Storti Foundation.

Chemical References

• Thalidomide
• Lenalidomide
• Melphalan
• Prednisone

Topics

• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Humans
• Lenalidomide (therapeutic use)
• Melphalan (therapeutic use)
• Multiple Myeloma (diagnosis, drug therapy)
• Prednisone (therapeutic use)
• Prospective Studies
• Quality of Life
• Thalidomide (therapeutic use)