Stefan Knop1, Maria-Victoria Mateos2, Meletios A Dimopoulos3, Kenshi Suzuki4, Andrzej Jakubowiak5, Chantal Doyen6, Paulo Lucio7, Zsolt Nagy8, Ganna Usenko9, Ludek Pour10, Mark Cook11, Sebastian Grosicki12, Andre Crepaldi13, Anna Marina Liberati14, Philip Campbell15, Tatiana Shelekhova16, Sung-Soo Yoon17, Genadi Losava18, Tomoaki Fujisaki19, Mamta Garg20, Jianping Wang21, Susan Wroblewski22, Anupa Kudva21, Katharine S Gries21, John Fastenau21, Jesus San-Miguel23, Michele Cavo24. 1. Department of Haematology and Oncology, Würzburg University Medical Center, Oberdürrbacher Straße 6, 97080, Würzburg, Germany. knop_s@ukw.de. 2. University Hospital of Salamanca-Instituto de Investigación Biomédica de Salamanca, Salamanca, Spain. 3. National and Kapodistrian University of Athens, Athens, Greece. 4. Japanese Red Cross Medical Center, Tokyo, Japan. 5. University of Chicago Medical Center, Chicago, IL, USA. 6. Université Catholique of Louvain, CHU UCL Namur, Yvoir, Belgium. 7. Champalimaud Centre for the Unknown, Lisbon, Portugal. 8. Semmelweis University, Budapest, Hungary. 9. Dnipropetrovsk City Multidisciplinary Clinical Hospital No. 4, Dnipropetrovsk, Ukraine. 10. University Hospital Brno, Brno, Czech Republic. 11. University Hospitals Birmingham NHS Trust, Birmingham, UK. 12. Silesian Medical University, Katowice, Poland. 13. Clinica de Tratamento E, Cuiaba, Brazil. 14. Azienda Ospedaliera "Santa Maria", Terni, Italy. 15. Andrew Love Cancer Centre, Geelong, Australia. 16. Clinic of Professional Pathology, Saratov, Russia. 17. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea. 18. LTD "Medinvent" Institute of Health, Tbilisi, Georgia. 19. Matsuyama Red Cross Hospital, Matsuyama, Japan. 20. Leicester Royal Infirmary, Leicester, UK. 21. Janssen Research and Development, Raritan, NJ, USA. 22. Janssen Research & Development, LLC, Spring House, PA, USA. 23. Clínica Universidad de Navarra-Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra, Centro de Investigación Biomédica en Red de Cáncer, Pamplona, Spain. 24. Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.
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 LifeQuestionnaire 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.
RCT Entities:
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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