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  • Nielsen, Lene KongsgaardOdense University Hospital (author)

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

  • Article/chapterEnglish2020

Publisher, publication year, extent ...

  • 2019-09-12
  • Ferrata Storti Foundation (Haematologica),2020
  • 10 s.

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  • LIBRIS-ID:oai:lup.lub.lu.se:78f8c9e1-3b92-4677-a542-20c86d4eec24
  • https://lup.lub.lu.se/record/78f8c9e1-3b92-4677-a542-20c86d4eec24URI
  • https://doi.org/10.3324/haematol.2019.222299DOI

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  • Language:English
  • Summary in:English

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  • Subject category:art swepub-publicationtype
  • Subject category:ref swepub-contenttype

Notes

  • 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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Added entries (persons, corporate bodies, meetings, titles ...)

  • Stege, ClaudiaVrije Universiteit Amsterdam (author)
  • Lissenberg-Witte, BirgitVrije Universiteit Amsterdam (author)
  • Der Holt, Bronno VanErasmus University Medical Center (author)
  • Mellqvist, Ulf HenrikSahlgrenska University Hospital (author)
  • Salomo, MortenCopenhagen University Hospital (author)
  • Bos, GerardYukioka Hospital (author)
  • Levin, Mark David (author)
  • Visser-Wisselaar, HeleenErasmus University Medical Center (author)
  • Hansson, MarkusLund University,Lunds universitet,Avdelningen för hematologi och transfusionsmedicin,Institutionen för laboratoriemedicin,Medicinska fakulteten,Myelomgruppen,Forskargrupper vid Lunds universitet,WCMM- Wallenberg center för molekylär medicinsk forskning,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Division of Hematology and Transfusion Medicine,Department of Laboratory Medicine,Faculty of Medicine,Myeloma research group,Lund University Research Groups,WCMM-Wallenberg Centre for Molecular Medicine,LUCC: Lund University Cancer Centre,Other Strong Research Environments,Skåne University Hospital(Swepub:lu)hema-mha (author)
  • Der Velden, Annette VanMartini Hospital, Groningen (author)
  • Deenik, Wendy (author)
  • Coenen, JuleonMaastricht University Medical Centre (author)
  • Hinge, MajaVejle Hospital (author)
  • Klein, SaskiaMeander Medical Center (author)
  • Tanis, Bea (author)
  • Szatkowski, Damian (author)
  • Brouwer, RolfReinier de Graaf Hospital - SSDZ (author)
  • Westerman, Matthijs (author)
  • Leys, Rineke (author)
  • Sinnige, HarmJeroen Bosch Hospital (author)
  • Haukås, EinarStavanger University Hospital (author)
  • Der Hem, Klaas Van (author)
  • Durian, Marc (author)
  • Gimsing, PeterCopenhagen University Hospital (author)
  • De Donk, Niels VanVrije Universiteit Amsterdam (author)
  • Sonneveld, PieterErasmus University Medical Center (author)
  • Waage, AndersSt. Olav’s University Hospital (author)
  • Abildgaard, NielsOdense University Hospital (author)
  • Zweegman, SonjaVrije Universiteit Amsterdam (author)
  • Odense University HospitalVrije Universiteit Amsterdam (creator_code:org_t)

Related titles

  • In:Haematologica: Ferrata Storti Foundation (Haematologica)105:6, s. 1650-16590390-60781592-8721

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