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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

Nielsen, Lene Kongsgaard ; Stege, Claudia ; Lissenberg-Witte, Birgit ; Der Holt, Bronno Van ; Mellqvist, Ulf Henrik ; Salomo, Morten ; Bos, Gerard ; Levin, Mark David ; Visser-Wisselaar, Heleen and Hansson, Markus LU orcid , et al. (2020) In Haematologica 105(6). p.1650-1659
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... (More)

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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Haematologica
volume
105
issue
6
pages
10 pages
publisher
Ferrata Storti Foundation
external identifiers
  • scopus:85085526661
  • pmid:31515355
ISSN
0390-6078
DOI
10.3324/haematol.2019.222299
language
English
LU publication?
yes
id
78f8c9e1-3b92-4677-a542-20c86d4eec24
date added to LUP
2020-12-22 11:01:33
date last changed
2024-06-28 06:50:57
@article{78f8c9e1-3b92-4677-a542-20c86d4eec24,
  abstract     = {{<p>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.</p>}},
  author       = {{Nielsen, Lene Kongsgaard and Stege, Claudia and Lissenberg-Witte, Birgit and Der Holt, Bronno Van and Mellqvist, Ulf Henrik and Salomo, Morten and Bos, Gerard and Levin, Mark David and Visser-Wisselaar, Heleen and Hansson, Markus and Der Velden, Annette Van and Deenik, Wendy and Coenen, Juleon and Hinge, Maja and Klein, Saskia and Tanis, Bea and Szatkowski, Damian and Brouwer, Rolf and Westerman, Matthijs and Leys, Rineke and Sinnige, Harm and Haukås, Einar and Der Hem, Klaas Van and Durian, Marc and Gimsing, Peter and De Donk, Niels Van and Sonneveld, Pieter and Waage, Anders and Abildgaard, Niels and Zweegman, Sonja}},
  issn         = {{0390-6078}},
  language     = {{eng}},
  number       = {{6}},
  pages        = {{1650--1659}},
  publisher    = {{Ferrata Storti Foundation}},
  series       = {{Haematologica}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.3324/haematol.2019.222299}},
  doi          = {{10.3324/haematol.2019.222299}},
  volume       = {{105}},
  year         = {{2020}},
}