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,
Maria-Victoria Mateos,
Meletios A. Dimopoulos,
Kenshi Suzuki,
Andrzej Jakubowiak,
Chantal Doyen,
Paulo Lucio,
Zsolt Nagy,
Ganna Usenko,
Ludek Pour,
Mark Cook,
Sebastian Grosicki,
Andre Crepaldi,
Anna Marina Liberati,
Philip Campbell,
Tatiana Shelekhova,
Sung-Soo Yoon,
Genadi Losava,
Tomoaki Fujisaki,
Mamta Garg,
Jianping Wang,
Susan Wroblewski,
Anupa Kudva,
Katharine S. Gries,
John Fastenau,
Jesus San-Miguel,
Michele Cavo
Affiliations
Stefan Knop
Department of Haematology and Oncology, Würzburg University Medical Center
Maria-Victoria Mateos
University Hospital of Salamanca–Instituto de Investigación Biomédica de Salamanca
Meletios A. Dimopoulos
National and Kapodistrian University of Athens
Kenshi Suzuki
Japanese Red Cross Medical Center
Andrzej Jakubowiak
University of Chicago Medical Center
Chantal Doyen
Université Catholique of Louvain, CHU UCL Namur
Paulo Lucio
Champalimaud Centre for the Unknown
Zsolt Nagy
Semmelweis University
Ganna Usenko
Dnipropetrovsk City Multidisciplinary Clinical Hospital No. 4
Ludek Pour
University Hospital Brno
Mark Cook
University Hospitals Birmingham NHS Trust
Sebastian Grosicki
Silesian Medical University
Andre Crepaldi
Clinica de Tratamento E
Anna Marina Liberati
Azienda Ospedaliera “Santa Maria”
Philip Campbell
Andrew Love Cancer Centre
Tatiana Shelekhova
Clinic of Professional Pathology
Sung-Soo Yoon
Department of Internal Medicine, Seoul National University College of Medicine
Genadi Losava
LTD “Medinvent” Institute of Health
Tomoaki Fujisaki
Matsuyama Red Cross Hospital
Mamta Garg
Leicester Royal Infirmary
Jianping Wang
Janssen Research and Development
Susan Wroblewski
Janssen Research & Development, LLC
Anupa Kudva
Janssen Research and Development
Katharine S. Gries
Janssen Research and Development
John Fastenau
Janssen Research and Development
Jesus San-Miguel
Clínica Universidad de Navarra–Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra, Centro de Investigación Biomédica en Red de Cáncer
Michele Cavo
Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna
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
