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

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 LeysHarm Sinnige, Einar Haukås, Klaas van der Hem, Marc Durian, Peter Gimsing, Niels van de Donk, Pieter Sonneveld, Anders Waage, Niels Abildgaard, Sonja Zweegman

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

Data on the impact of long term treatment with IMiDs on health-related quality of life 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 3 and 9 induction cycles and 6 and 12 months of maintenance therapy. Linear mixed models and minimal important differences were used for evaluation. 596 patients participated in health-related quality of life reporting. Patients reported clinically relevant improvement in global quality of life, 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 to 12 months of maintenance only and was independent of WHO 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 3 months reported clinically meaningful improvement in global QoL and role functioning at 6 months, remaining stable thereafter. There were no clinically meaningful deteriorations, but patients on thalidomide reported clinically relevant worsening in neuropathy. In general, health-related quality of life improves both during induction and maintenance therapy with IMiDs. Side effect profile of treatment did not negatively affect global quality of life, but it was, however, clinically relevant for the patients. (Clinicaltrials.gov identifier: NTR1630).

OriginalsprogEngelsk
TidsskriftHaematologica
ISSN0390-6078
DOI
StatusE-pub ahead of print - 12. sep. 2019

Fingeraftryk

Quality of Life
Melphalan
Linear Models
Maintenance
Incidence

Bibliografisk note

Copyright © 2019, Ferrata Storti Foundation.

Citer dette

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. I: Haematologica. 2019.
@article{f0e1b16251c34f23982cf62843199f49,
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 IMiDs on health-related quality of life 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 3 and 9 induction cycles and 6 and 12 months of maintenance therapy. Linear mixed models and minimal important differences were used for evaluation. 596 patients participated in health-related quality of life reporting. Patients reported clinically relevant improvement in global quality of life, 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 to 12 months of maintenance only and was independent of WHO 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 3 months reported clinically meaningful improvement in global QoL and role functioning at 6 months, remaining stable thereafter. There were no clinically meaningful deteriorations, but patients on thalidomide reported clinically relevant worsening in neuropathy. In general, health-related quality of life improves both during induction and maintenance therapy with IMiDs. Side effect profile of treatment did not negatively affect global quality of life, 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 {\circledC} 2019, Ferrata Storti Foundation.",
year = "2019",
month = "9",
day = "12",
doi = "10.3324/haematol.2019.222299",
language = "English",
journal = "Haematologica",
issn = "0390-6078",
publisher = "Ferrata Storti Foundation",

}

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 2019, '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. https://doi.org/10.3324/haematol.2019.222299

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; 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.

I: Haematologica, 12.09.2019.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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 © 2019, Ferrata Storti Foundation.

PY - 2019/9/12

Y1 - 2019/9/12

N2 - Data on the impact of long term treatment with IMiDs on health-related quality of life 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 3 and 9 induction cycles and 6 and 12 months of maintenance therapy. Linear mixed models and minimal important differences were used for evaluation. 596 patients participated in health-related quality of life reporting. Patients reported clinically relevant improvement in global quality of life, 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 to 12 months of maintenance only and was independent of WHO 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 3 months reported clinically meaningful improvement in global QoL and role functioning at 6 months, remaining stable thereafter. There were no clinically meaningful deteriorations, but patients on thalidomide reported clinically relevant worsening in neuropathy. In general, health-related quality of life improves both during induction and maintenance therapy with IMiDs. Side effect profile of treatment did not negatively affect global quality of life, but it was, however, clinically relevant for the patients. (Clinicaltrials.gov identifier: NTR1630).

AB - Data on the impact of long term treatment with IMiDs on health-related quality of life 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 3 and 9 induction cycles and 6 and 12 months of maintenance therapy. Linear mixed models and minimal important differences were used for evaluation. 596 patients participated in health-related quality of life reporting. Patients reported clinically relevant improvement in global quality of life, 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 to 12 months of maintenance only and was independent of WHO 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 3 months reported clinically meaningful improvement in global QoL and role functioning at 6 months, remaining stable thereafter. There were no clinically meaningful deteriorations, but patients on thalidomide reported clinically relevant worsening in neuropathy. In general, health-related quality of life improves both during induction and maintenance therapy with IMiDs. Side effect profile of treatment did not negatively affect global quality of life, 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

JO - Haematologica

JF - Haematologica

SN - 0390-6078

ER -