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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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Harvard

Nielsen, LK, Stege, C, Lissenberg-Witte, B, van der Holt, B, Mellqvist, U-H, Salomo, M, Bos, G, Levin, M-D, Visser-Wisselaar, H, Hansson, M, van der Velden, A, Deenik, W, Coenen, J, Hinge, M, Klein, S, Tanis, B, Szatkowski, D, Brouwer, R, Westerman, M, Leys, R, Sinnige, H, Haukås, E, van der Hem, K, Durian, M, Gimsing, P, van de Donk, N, Sonneveld, P, Waage, A, Abildgaard, N & Zweegman, S 2020, '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', Haematologica, vol. 105, no. 6, pp. 1650-1659. https://doi.org/10.3324/haematol.2019.222299

APA

Nielsen, L. K., Stege, C., Lissenberg-Witte, B., van der Holt, B., Mellqvist, U-H., Salomo, M., Bos, G., Levin, M-D., Visser-Wisselaar, H., Hansson, M., van der Velden, A., Deenik, W., Coenen, J., Hinge, M., Klein, S., Tanis, B., Szatkowski, D., Brouwer, R., Westerman, M., ... Zweegman, S. (2020). 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. Haematologica, 105(6), 1650-1659. https://doi.org/10.3324/haematol.2019.222299

CBE

Nielsen LK, Stege C, Lissenberg-Witte B, van der Holt B, Mellqvist U-H, Salomo M, Bos G, Levin M-D, Visser-Wisselaar H, Hansson M, van der Velden A, Deenik W, Coenen J, Hinge M, Klein S, Tanis B, Szatkowski D, Brouwer R, Westerman M, Leys R, Sinnige H, Haukås E, van der Hem K, Durian M, Gimsing P, van de Donk N, Sonneveld P, Waage A, Abildgaard N, Zweegman S. 2020. 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. Haematologica. 105(6):1650-1659. https://doi.org/10.3324/haematol.2019.222299

MLA

Vancouver

Author

Nielsen, Lene Kongsgaard ; Stege, Claudia ; Lissenberg-Witte, Birgit ; van der Holt, Bronno ; Mellqvist, Ulf-Henrik ; Salomo, Morten ; Bos, Gerard ; Levin, Mark-David ; Visser-Wisselaar, Heleen ; Hansson, Markus ; van der Velden, Annette ; Deenik, Wendy ; Coenen, Juleon ; Hinge, Maja ; Klein, Saskia ; Tanis, Bea ; Szatkowski, Damian ; Brouwer, Rolf ; Westerman, Matthijs ; Leys, Rineke ; Sinnige, Harm ; Haukås, Einar ; van der Hem, Klaas ; Durian, Marc ; Gimsing, Peter ; van de Donk, Niels ; Sonneveld, Pieter ; Waage, Anders ; Abildgaard, Niels ; Zweegman, Sonja. / 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. In: Haematologica. 2020 ; Vol. 105, No. 6. pp. 1650-1659.

Bibtex

@article{f75a5dee806b4ffeaccb50d9cfa435e3,
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",
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). ",
author = "Nielsen, {Lene Kongsgaard} and Claudia Stege and Birgit Lissenberg-Witte and {van der Holt}, Bronno and Ulf-Henrik Mellqvist and Morten Salomo and Gerard Bos and Mark-David Levin and Heleen Visser-Wisselaar and Markus Hansson and {van der Velden}, Annette and Wendy Deenik and Juleon Coenen and Maja Hinge and Saskia Klein and Bea Tanis and Damian Szatkowski and Rolf Brouwer and Matthijs Westerman and Rineke Leys and Harm Sinnige and Einar Hauk{\aa}s and {van der Hem}, Klaas and Marc Durian and Peter Gimsing and {van de Donk}, Niels and Pieter Sonneveld and Anders Waage and Niels Abildgaard and Sonja Zweegman",
note = "Copyright{\textcopyright} 2020 Ferrata Storti Foundation.",
year = "2020",
month = jun,
doi = "10.3324/haematol.2019.222299",
language = "English",
volume = "105",
pages = "1650--1659",
journal = "Haematologica",
issn = "0390-6078",
publisher = "Fondazione/Ferrata Storti",
number = "6",

}

RIS

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 - van der Holt, Bronno

AU - Mellqvist, Ulf-Henrik

AU - Salomo, Morten

AU - Bos, Gerard

AU - Levin, Mark-David

AU - Visser-Wisselaar, Heleen

AU - Hansson, Markus

AU - van der Velden, Annette

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 - van der Hem, Klaas

AU - Durian, Marc

AU - Gimsing, Peter

AU - van de Donk, Niels

AU - Sonneveld, Pieter

AU - Waage, Anders

AU - Abildgaard, Niels

AU - Zweegman, Sonja

N1 - Copyright© 2020 Ferrata Storti Foundation.

PY - 2020/6

Y1 - 2020/6

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. ( Clinicaltrials.gov identifier: NTR1630).

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. ( Clinicaltrials.gov identifier: NTR1630).

U2 - 10.3324/haematol.2019.222299

DO - 10.3324/haematol.2019.222299

M3 - Journal article

C2 - 31515355

VL - 105

SP - 1650

EP - 1659

JO - Haematologica

JF - Haematologica

SN - 0390-6078

IS - 6

ER -

ID: 59156343