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Clinical Trial
. 2021 Jun 2;21(1):659.
doi: 10.1186/s12885-021-08325-2.

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

Stefan Knop  1 , Maria-Victoria Mateos  2 , Meletios A Dimopoulos  3 , Kenshi Suzuki  4 , Andrzej Jakubowiak  5 , Chantal Doyen  6 , Paulo Lucio  7 , Zsolt Nagy  8 , Ganna Usenko  9 , Ludek Pour  10 , Mark Cook  11 , Sebastian Grosicki  12 , Andre Crepaldi  13 , Anna Marina Liberati  14 , Philip Campbell  15 , Tatiana Shelekhova  16 , Sung-Soo Yoon  17 , Genadi Losava  18 , Tomoaki Fujisaki  19 , Mamta Garg  20 , Jianping Wang  21 , Susan Wroblewski  22 , Anupa Kudva  21 , Katharine S Gries  21 , John Fastenau  21 , Jesus San-Miguel  23 , Michele Cavo  24
Affiliations
Clinical Trial

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

Stefan Knop et al. BMC Cancer. .

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.

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Conflict of interest statement

Stefan Knop received honoraria from Amgen, Bristol-Myers Squibb, Celgene, Janssen and Takeda; served as a consultant or in an advisory role for Amgen, Bristol-Myers Squibb, Celgene, Janssen and Takeda; and received research funding from Amgen, Bristol-Myers Squibb, Celgene, Janssen and Takeda. Maria-Victoria Mateos has received honoraria from Adaptive Biotechnologies, Amgen, Celgene, Janssen Pharmaceuticals and Takeda; served on the Board of Directors or advisory committees for AbbVie, Amgen, Celgene, GenTech, GlaxoSmithKline, Janssen Pharmaceuticals, Mundipharma, PharmaMar, Roche and Takeda; served on data and monitoring committees for Amgen and Janssen Pharmaceuticals; and served on speakers bureaus for Amgen, Celgene, Janssen Pharmaceuticals and Takeda. Meletios A. Dimopoulos has received consulting fees, honoraria and research funding from Amgen, Celgene, Janssen and Takeda; and participated in advisory boards for Sanofi-Aventis. Kenishi Suzuki received honoraria from Bristol-Myers Squibb, Celgene, Janssen, Novartis, Ono, Takeda and Sanofi-Aventis; served as a consultant or in an advisory role for Bristol-Myers Squibb, Celgene, Janssen, Novartis, Ono, Takeda and Sanofi-Aventis; and is employed by SRL. Andrzej Jakubowiak received honoraria from AbbVie, Adaptive Biotechnologies, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Karyopharm, SkylineDx and Takeda; and served as a consultant or in an advisory role for AbbVie, Adaptive Biotechnologies, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Karyopharm, SkylineDx and Takeda. Chantal Doyen served as a consultant or in an advisory role for Janssen. Paulo Lucio received honoraria from Amgen, Celgene, Janssen and Takeda; and served as a consultant or in an advisory role for Amgen, Celgene, Janssen and Takeda. Mark Cook received honoraria from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen and Takeda; served as a consultant or in an advisory role for AbbVie, Amgen, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen and Takeda; received research support from Celgene and Janssen; and served on a speakers bureau for Celgene and Janssen. Sebastian Grosicki received research funding from Affimed. Sung-Soo Yoon served as a consultant or in an advisory role for Amgen, Astellas, Celgene, Chugai, Janssen, Novartis and Takeda; received honoraria from Novartis; and received research funding from Kyowa Kirin, Roche-Genentech and Yuhan Pharmaceutical. Mamta Garg has received honoraria from Amgen and Janssen; research funding from Novartis; and travel accommodations and expenses from Amgen, Novartis and Takeda. Jianping Wang, Susan Wroblewski, Anupa Kudva, Katharine S. Gries and John Fastenau are employed by Janssen. Jesus San-Miguel received honoraria from Amgen, Bristol-Myers Squibb, Celgene, Janssen, Novartis, Roche and Sanofi. Michele Cavo has consulted for AbbVie, Amgen, Celgene and Janssen Pharmaceuticals; received honoraria from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen Pharmaceuticals and Takeda; and served on speakers bureaus for and received travel and/or accommodation expenses from Celgene and Janssen Pharmaceuticals. Zsolt Nagy, Ganna Usenko, Ludek Pour, Andre Crepaldi, Anna Marina Liberati, Philip Campbell, Tatiana Shelekhova, Genadi Iosava and Tomoaki Fujisaki have nothing to disclose.

Figures

Fig. 1
Fig. 1
LS mean change from baseline in EORTC QLQ-C30. a – GHS. b – Physical functioning. c – Pain. d – Fatigue up to 36 months (ITT population)
Fig. 2
Fig. 2
Percentage of patients reporting clinically meaningful improvements in EORTC QLQ-C30 functional and symptom scales at 36 months. Clinically meaningful improvement defined as a ≥ 10-point improvement from baseline score
Fig. 3
Fig. 3
EQ-5D-5L VAS. a – LS mean change from baseline up to 36 months. b – Percentage of patients reporting clinically meaningful improvements up to 36 months (ITT population)
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References

    1. Moreau P, San Miguel J, Sonneveld P, Mateos MV, Zamagni E, Avet-Loiseau H, Hajek R, Dimopoulos MA, Ludwig H, Einsele H, et al. Multiple myeloma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017;28(suppl 4):iv52–iv61. doi: 10.1093/annonc/mdx096. - DOI - PubMed
    1. Szabo K, Bodoki L, Nagy-Vincze M, Vincze A, Zilahi E, Szodoray P, Danko K, Griger Z. Effect of genetic and laboratory findings on clinical course of Antisynthetase syndrome in a Hungarian cohort. Biomed Res Int. 2018;2018:6416378. doi: 10.1155/2018/6416378. - DOI - PMC - PubMed
    1. Rodriguez-Otero P, Mateos MV, Martinez-Lopez J, Hernandez MT, Ocio EM, Rosinol L, Martinez R, Teruel AI, Gutierrez NC, Bargay J, et al. Predicting long-term disease control in transplant-ineligible patients with multiple myeloma: impact of an MGUS-like signature. Blood Cancer J. 2019;9(4):36. doi: 10.1038/s41408-019-0176-x. - DOI - PMC - PubMed
    1. Moreau P, Attal M, Facon T. Frontline therapy of multiple myeloma. Blood. 2015;125(20):3076–3084. doi: 10.1182/blood-2014-09-568915. - DOI - PubMed
    1. Gandolfi S, Vekstein C, Laubach JP, O'Brien A, Masone K, Munshi NC, Anderson KC, Richardson PG. The evolving role of transplantation in multiple myeloma: the need for a heterogeneous approach to a heterogeneous disease. Clin Adv Hematol Oncol. 2018;16(8):564–574. - PubMed

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