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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

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  1. The ASXL1-G643W variant accelerates the development of CEBPA mutant acute myeloid leukemia

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  2. Myelodysplastic syndrome patient-derived xenografts: from no options to many

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  3. KMT2D mutations and TP53 disruptions are poor prognostic biomarkers in mantle cell lymphoma receiving high-dose therapy: a FIL study

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  4. Optimized EBMT transplant-specific risk score in myelodysplastic syndromes after allogeneic stem-cell transplantation

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  1. Association of Choroidal Effusion and Infusion of Daratumumab

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  2. Risk factors for infections in newly diagnosed Multiple Myeloma patients: A Danish retrospective nationwide cohort study

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  3. The majority of newly diagnosed myeloma patients do not fulfill the inclusion criteria in clinical phase III trials

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  4. Risk factors for blood stream infections in multiple myeloma: A population-based study of 1154 patients in Denmark

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  • 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
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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).

Original languageEnglish
JournalHaematologica
Volume105
Issue number6
Pages (from-to)1650-1659
Number of pages10
ISSN0390-6078
DOIs
Publication statusPublished - Jun 2020

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