TY - JOUR
T1 - Health-related quality of life in transplant ineligible newly diagnosed multiple myeloma patients treated with either thalidomide or lenalidomide-based regimen until progression
T2 - A prospective, open-label, multicenter, randomized, phase 3 study
AU - Nielsen, Lene Kongsgaard
AU - Stege, Claudia
AU - Lissenberg-Witte, Birgit
AU - Der Holt, Bronno Van
AU - Mellqvist, Ulf Henrik
AU - Salomo, Morten
AU - Bos, Gerard
AU - Levin, Mark David
AU - Visser-Wisselaar, Heleen
AU - Hansson, Markus
AU - Der Velden, Annette Van
AU - Deenik, Wendy
AU - Coenen, Juleon
AU - Hinge, Maja
AU - Klein, Saskia
AU - Tanis, Bea
AU - Szatkowski, Damian
AU - Brouwer, Rolf
AU - Westerman, Matthijs
AU - Leys, Rineke
AU - Sinnige, Harm
AU - Haukås, Einar
AU - Der Hem, Klaas Van
AU - Durian, Marc
AU - Gimsing, Peter
AU - De Donk, Niels Van
AU - Sonneveld, Pieter
AU - Waage, Anders
AU - Abildgaard, Niels
AU - Zweegman, Sonja
PY - 2020
Y1 - 2020
N2 - 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.
AB - 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.
U2 - 10.3324/haematol.2019.222299
DO - 10.3324/haematol.2019.222299
M3 - Article
C2 - 31515355
AN - SCOPUS:85085526661
SN - 1592-8721
VL - 105
SP - 1650
EP - 1659
JO - Haematologica-The Hematology Journal
JF - Haematologica-The Hematology Journal
IS - 6
ER -