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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
DC Field | Value | Language |
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dc.contributor.author | Knop, Stefan | - |
dc.contributor.author | Mateos, Maria-Victoria | - |
dc.contributor.author | Dimopoulos, Meletios A. | - |
dc.contributor.author | Suzuki, Kenshi | - |
dc.contributor.author | Jakubowiak, Andrzej | - |
dc.contributor.author | Doyen, Chantal | - |
dc.contributor.author | Lucio, Paulo | - |
dc.contributor.author | Nagy, Zsolt | - |
dc.contributor.author | Usenko, Ganna | - |
dc.contributor.author | Pour, Ludek | - |
dc.contributor.author | Cook, Mark | - |
dc.contributor.author | Grosicki, Sebastian | - |
dc.contributor.author | Crepaldi, Andre | - |
dc.contributor.author | Liberati, Anna M. | - |
dc.contributor.author | Campbell, Philip | - |
dc.contributor.author | Shelekhova, Tatiana | - |
dc.contributor.author | Yoon, Sung-Soo | - |
dc.contributor.author | Losava, Genadi | - |
dc.contributor.author | Fujisaki, Tomoaki | - |
dc.contributor.author | Garg, Mamta | - |
dc.contributor.author | Wang, Jianping | - |
dc.contributor.author | Wroblewski, Susan | - |
dc.contributor.author | Kudva, Anupa | - |
dc.contributor.author | Gries, Katharine S. | - |
dc.contributor.author | Fastenau, John | - |
dc.contributor.author | San-Miguel, Jesus | - |
dc.contributor.author | Cavo, Michele | - |
dc.date.accessioned | 2021-08-10T05:15:20Z | - |
dc.date.available | 2021-08-11T14:14:10Z | - |
dc.date.issued | 2021-06-02 | - |
dc.identifier.citation | BMC Cancer. 2021 Jun 02;21(1):659 | ko_KR |
dc.identifier.issn | 1471-2407 | - |
dc.identifier.uri | https://doi.org/10.1186/s12885-021-08325-2 | - |
dc.identifier.uri | https://hdl.handle.net/10371/174777 | - |
dc.description.abstract | 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 | ko_KR |
dc.description.sponsorship | Funding for the ALCYONE (NCT02195479) study was provided by Janssen Research & Development, LLC. The sponsor and authors were jointly responsible for the conception and design, and data analysis. Medical writing support was provided by Linda Wychowski, PhD, and Corey Eagan, MPH, of Eloquent Scientific Solutions, and funded by Janssen Global Services, LLC. All the authors reviewed, revised, and approved the manuscript for submission. The sponsor and authors vouch for data accuracy and
completeness. | ko_KR |
dc.language.iso | en | ko_KR |
dc.publisher | BMC | ko_KR |
dc.subject | ClinicalTrials.gov identifier NCT02195479 | - |
dc.subject | registered September 21, 2014 | - |
dc.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 | ko_KR |
dc.type | Article | ko_KR |
dc.contributor.AlternativeAuthor | 윤성수 | - |
dc.citation.journaltitle | BMC Cancer | ko_KR |
dc.language.rfc3066 | en | - |
dc.rights.holder | The Author(s) | - |
dc.date.updated | 2021-06-06T03:10:25Z | - |
dc.citation.number | 1 | ko_KR |
dc.citation.startpage | 659 | ko_KR |
dc.citation.volume | 21 | ko_KR |
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