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Health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: results from the randomized phase III ALCYONE trial

BACKGROUND: In the phase III ALCYONE trial, daratumumab plus bortezomib/melphalan/prednisone (D-VMP) significantly improved overall response rate and progression-free status compared with VMP alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). Here, we present patie...

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Autores principales: Knop, Stefan, Mateos, Maria-Victoria, Dimopoulos, Meletios A., Suzuki, Kenshi, Jakubowiak, Andrzej, Doyen, Chantal, Lucio, Paulo, Nagy, Zsolt, Usenko, Ganna, Pour, Ludek, Cook, Mark, Grosicki, Sebastian, Crepaldi, Andre, Liberati, Anna Marina, Campbell, Philip, Shelekhova, Tatiana, Yoon, Sung-Soo, Losava, Genadi, Fujisaki, Tomoaki, Garg, Mamta, Wang, Jianping, Wroblewski, Susan, Kudva, Anupa, Gries, Katharine S., Fastenau, John, San-Miguel, Jesus, Cavo, Michele
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8170980/
https://www.ncbi.nlm.nih.gov/pubmed/34078314
http://dx.doi.org/10.1186/s12885-021-08325-2
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author Knop, Stefan
Mateos, Maria-Victoria
Dimopoulos, Meletios A.
Suzuki, Kenshi
Jakubowiak, Andrzej
Doyen, Chantal
Lucio, Paulo
Nagy, Zsolt
Usenko, Ganna
Pour, Ludek
Cook, Mark
Grosicki, Sebastian
Crepaldi, Andre
Liberati, Anna Marina
Campbell, Philip
Shelekhova, Tatiana
Yoon, Sung-Soo
Losava, Genadi
Fujisaki, Tomoaki
Garg, Mamta
Wang, Jianping
Wroblewski, Susan
Kudva, Anupa
Gries, Katharine S.
Fastenau, John
San-Miguel, Jesus
Cavo, Michele
author_facet Knop, Stefan
Mateos, Maria-Victoria
Dimopoulos, Meletios A.
Suzuki, Kenshi
Jakubowiak, Andrzej
Doyen, Chantal
Lucio, Paulo
Nagy, Zsolt
Usenko, Ganna
Pour, Ludek
Cook, Mark
Grosicki, Sebastian
Crepaldi, Andre
Liberati, Anna Marina
Campbell, Philip
Shelekhova, Tatiana
Yoon, Sung-Soo
Losava, Genadi
Fujisaki, Tomoaki
Garg, Mamta
Wang, Jianping
Wroblewski, Susan
Kudva, Anupa
Gries, Katharine S.
Fastenau, John
San-Miguel, Jesus
Cavo, Michele
author_sort Knop, Stefan
collection PubMed
description BACKGROUND: In the phase III ALCYONE trial, daratumumab plus bortezomib/melphalan/prednisone (D-VMP) significantly improved overall response rate and progression-free status compared with VMP alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). Here, we present patient-reported outcomes (PROs) from ALCYONE. METHODS: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) and EuroQol 5-dimensional descriptive system (EQ-5D-5L) questionnaire were administered at baseline, every 3 months (year 1) and every 6 months (until progression). Treatment effects were assessed using a repeated-measures, mixed-effects model. RESULTS: Compliance with PRO assessments was comparable at baseline (> 90%) and throughout study (> 76%) for both treatment groups. Improvements from baseline were observed in both groups for EORTC QLQ-C30 Global Health Status (GHS), most functional scales, symptom scales and EQ-5D-5L visual analog scale (VAS). Between-group differences were significant for GHS (p = 0.0240) and VAS (p = 0.0160) at month 3. Improvements in pain were clinically meaningful in both groups at all assessment time points. Cognitive function declined in both groups, but the magnitude of the decline was not clinically meaningful. CONCLUSIONS: Patients with transplant-ineligible NDMM demonstrated early and continuous improvements in health-related quality of life, including improvements in functioning and symptoms, following treatment with D-VMP or VMP. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02195479, registered September 21, 2014 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12885-021-08325-2.
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spelling pubmed-81709802021-06-03 Health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: results from the randomized phase III ALCYONE trial Knop, Stefan Mateos, Maria-Victoria Dimopoulos, Meletios A. Suzuki, Kenshi Jakubowiak, Andrzej Doyen, Chantal Lucio, Paulo Nagy, Zsolt Usenko, Ganna Pour, Ludek Cook, Mark Grosicki, Sebastian Crepaldi, Andre Liberati, Anna Marina Campbell, Philip Shelekhova, Tatiana Yoon, Sung-Soo Losava, Genadi Fujisaki, Tomoaki Garg, Mamta Wang, Jianping Wroblewski, Susan Kudva, Anupa Gries, Katharine S. Fastenau, John San-Miguel, Jesus Cavo, Michele BMC Cancer Research Article BACKGROUND: In the phase III ALCYONE trial, daratumumab plus bortezomib/melphalan/prednisone (D-VMP) significantly improved overall response rate and progression-free status compared with VMP alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). Here, we present patient-reported outcomes (PROs) from ALCYONE. METHODS: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) and EuroQol 5-dimensional descriptive system (EQ-5D-5L) questionnaire were administered at baseline, every 3 months (year 1) and every 6 months (until progression). Treatment effects were assessed using a repeated-measures, mixed-effects model. RESULTS: Compliance with PRO assessments was comparable at baseline (> 90%) and throughout study (> 76%) for both treatment groups. Improvements from baseline were observed in both groups for EORTC QLQ-C30 Global Health Status (GHS), most functional scales, symptom scales and EQ-5D-5L visual analog scale (VAS). Between-group differences were significant for GHS (p = 0.0240) and VAS (p = 0.0160) at month 3. Improvements in pain were clinically meaningful in both groups at all assessment time points. Cognitive function declined in both groups, but the magnitude of the decline was not clinically meaningful. CONCLUSIONS: Patients with transplant-ineligible NDMM demonstrated early and continuous improvements in health-related quality of life, including improvements in functioning and symptoms, following treatment with D-VMP or VMP. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02195479, registered September 21, 2014 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12885-021-08325-2. BioMed Central 2021-06-02 /pmc/articles/PMC8170980/ /pubmed/34078314 http://dx.doi.org/10.1186/s12885-021-08325-2 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research Article
Knop, Stefan
Mateos, Maria-Victoria
Dimopoulos, Meletios A.
Suzuki, Kenshi
Jakubowiak, Andrzej
Doyen, Chantal
Lucio, Paulo
Nagy, Zsolt
Usenko, Ganna
Pour, Ludek
Cook, Mark
Grosicki, Sebastian
Crepaldi, Andre
Liberati, Anna Marina
Campbell, Philip
Shelekhova, Tatiana
Yoon, Sung-Soo
Losava, Genadi
Fujisaki, Tomoaki
Garg, Mamta
Wang, Jianping
Wroblewski, Susan
Kudva, Anupa
Gries, Katharine S.
Fastenau, John
San-Miguel, Jesus
Cavo, Michele
Health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: results from the randomized phase III ALCYONE trial
title Health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: results from the randomized phase III ALCYONE trial
title_full Health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: results from the randomized phase III ALCYONE trial
title_fullStr Health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: results from the randomized phase III ALCYONE trial
title_full_unstemmed Health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: results from the randomized phase III ALCYONE trial
title_short Health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: results from the randomized phase III ALCYONE trial
title_sort health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: results from the randomized phase iii alcyone trial
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8170980/
https://www.ncbi.nlm.nih.gov/pubmed/34078314
http://dx.doi.org/10.1186/s12885-021-08325-2
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