Assessment of the psychometric properties of the Spanish version of EORTC QLQ-MY20 and evaluation of health-related quality of Life outcomes in patients with relapsed and/or refractory multiple myeloma in the real-world setting in Spain: results from the CharisMMa study

References

• Rajkumar SV. Multiple myeloma: 2016 update on diagnosis, risk-stratification, and management. Am J Hematol. 2016;91(7):719–734. doi:10.1002/ajh.24402
   PubMed Web of Science ®Google Scholar
• Multiple Myeloma Research Foundation - MMRF [Internet]. [cited 2019 Jun 11]. Available from: https://themmrf.org/.
   Google Scholar
• Palumbo A, Anderson K. Multiple myeloma. N Engl J Med. 2011;364(11):1046–1060. doi:10.1056/NEJMra1011442
   PubMed Web of Science ®Google Scholar
• Moreau P, San Miguel J, Ludwig H, et al. Multiple myeloma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013;24 Suppl 6(6):vi133–7. doi:10.1093/annonc/mdt297
   PubMedGoogle Scholar
• Laubach J, Garderet L, Mahindra A, et al. Management of relapsed multiple myeloma: recommendations of the international myeloma working group. Leukemia. 2016;30(5):1005–1017. doi:10.1038/leu.2015.356
   PubMed Web of Science ®Google Scholar
• Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26(1):149–157. doi:10.1038/leu.2011.196
   PubMed Web of Science ®Google Scholar
• Cornell RF, Kassim AA. Evolving paradigms in the treatment of relapsed/refractory multiple myeloma: increased options and increased complexity. Bone Marrow Transplant. 2016;51(4):479–491. doi:10.1038/bmt.2015.307
   PubMed Web of Science ®Google Scholar
• Ocio EM, Richardson PG, Rajkumar SV, et al. New drugs and novel mechanisms of action in multiple myeloma in 2013: a report from the international myeloma working group (IMWG). Leukemia. 2014;28(3):525–542. doi:10.1038/leu.2013.350
   PubMed Web of Science ®Google Scholar
• Sonneveld P, Broijl A. Treatment of relapsed and refractory multiple myeloma. Haematologica. 2016;101(4):396–406. doi:10.3324/haematol.2015.129189
   PubMed Web of Science ®Google Scholar
• Maes H, Delforge M. Optimizing quality of life in multiple myeloma patients: current options, challenges and recommendations. Expert Rev Hematol. 2015;8(3):355–366. doi:10.1586/17474086.2015.1021772
   PubMed Web of Science ®Google Scholar
• Johnsen AT, Tholstrup D, Petersen MA, et al. Health related quality of life in a nationally representative sample of haematological patients. Eur J Haematol. 2009;83(2):139–148. doi:10.1111/j.1600-0609.2009.01250.x
   PubMed Web of Science ®Google Scholar
• Quinten C, Coens C, Mauer M, et al. Baseline quality of life as a prognostic indicator of survival: a meta-analysis of individual patient data from EORTC clinical trials. Lancet Oncol. 2009;10(9):865–871. doi:10.1016/S1470-2045(09)70200-1
   PubMed Web of Science ®Google Scholar
• Gotay CC, Kawamoto CT, Bottomley A, et al. The prognostic significance of patient-reported outcomes in cancer clinical trials. J Clin Oncol. 2008;26(8):1355–1363. doi:10.1200/JCO.2007.13.3439
   PubMed Web of Science ®Google Scholar
• Wisloff F, Eika S, Hippe E, et al. Measurement of health-related quality of life in multiple myeloma. Br J Haematol. 1996;92(3):604–613. doi:10.1046/j.1365-2141.1996.352889.x
   PubMed Web of Science ®Google Scholar
• Mols F, Oerlemans S, Vos AH, et al. Health-related quality of life and disease-specific complaints among multiple myeloma patients up to 10 yr after diagnosis: results from a population-based study using the PROFILES registry. Eur J Haematol. 2012;89(4):311–319. doi:10.1111/j.1600-0609.2012.01831.x
   PubMed Web of Science ®Google Scholar
• Delforge M, Michiels A, Doyen C, et al. Lenalidomide in relapsed refractory myeloma patients: impact of previous response to bortezomib and thalidomide on treatment efficacy. Results of a medical need program in Belgium. Acta Clin Belg. 2011;66(5):371–375.
   PubMed Web of Science ®Google Scholar
• Despiégel N, Touboul C, Flinois A, et al. Health-related quality of life of patients with multiple myeloma treated in routine clinical practice in France. Clin Lymphoma Myeloma Leuk. 2019;19(1):e13–28–e28. doi:10.1016/j.clml.2018.08.019
   Web of Science ®Google Scholar
• Arraras JI, Arias F, Tejedor M, et al. The EORTC QLQ-C30 (version 3.0) Quality of life questionnaire: validation study for Spain with head and neck cancer patients. Psychooncology. 2002;11(3):249–256. doi:10.1002/pon.555
   PubMed Web of Science ®Google Scholar
• Espinoza-Zamora JR, Portilla-Espinosa CM, Labardini-Méndez JR, et al. Quality of life in multiple myeloma: clinical validation of the Mexican-Spanish version of the QLQ-MY20 instrument. Ann Hematol. 2015;94(6):1017–1024. doi:10.1007/s00277-014-2290-y
   PubMed Web of Science ®Google Scholar
• Rajkumar SV, Harousseau JL, Durie B, et al. Consensus recommendations for the uniform reporting of clinical trials: report of the international myeloma workshop consensus panel 1. Blood. 2011;117(18):4691–4695. doi:10.1182/blood-2010-10-299487
   PubMed Web of Science ®Google Scholar
• Aaronson NK, Ahmedzai S, Bergman B, et al. The european organization for research and treatment of cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365–376.
   PubMed Web of Science ®Google Scholar
• Alegre A, Oriol-Rocafiguera A, Garcia-Larana J, et al. Efficacy, safety and quality-of-life associated with lenalidomide plus dexamethasone for the treatment of relapsed or refractory multiple myeloma: the Spanish experience. Leuk Lymphoma. 2012;53(9):1714–1721. doi:10.3109/10428194.2012.662643
   PubMed Web of Science ®Google Scholar
• Stead ML, Brown JM, Velikova G, et al. Development of an EORTC questionnaire module to be used in health-related quality-of-life assessment for patients with multiple myeloma. Br J Haematol. 1999;104(3):605–611. doi:10.1046/j.1365-2141.1999.01206.x
   PubMed Web of Science ®Google Scholar
• Cocks K, Cohen D, Wisløff F, et al. An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-MY20) in assessing the quality of life of patients with multiple myeloma. Eur J Cancer. 2007;43(11):1670–1678. doi:10.1016/j.ejca.2007.04.022
   PubMed Web of Science ®Google Scholar
• Fayers P, Aaronson N, Bjordal K, Groenvold M, Curran D, Bottomley A, et al. EORTC QLQ-C30 Scoring Manual (3rd Edition) [Internet]. Brussels: European Organisation for Research and Treatment of Cancer; 2001 [cited 2023 Jul 27]. p. 1–78. Available from: https://www.eortc.org/app/uploads/sites/2/2018/02/SCmanual.pdf
   Google Scholar
• Ahmadzadeh A, Yekaninejad MS, Saffari M, et al. Reliability and validity of an Iranian version of the European organisation for research and treatment of cancer quality of life questionnaire for patients with multiple myeloma: the EORTC QLQ-MY20. Asian Pac J Cancer Prev. 2016;17(1):255–259. doi:10.7314/apjcp.2016.17.1.255
   PubMedGoogle Scholar
• Rosner B. Fundamentals of biostatistics. 8th ed. Boston: Cengage Learning; 2016.
   Google Scholar
• Ocio EM, Montes-Gaisán C, Bustamante G, et al. Clinical and sociodemographic characteristics of patients with relapsed and/or refractory multiple myeloma and their influence on treatment in the real-world setting in Spain: the CharisMMa study. Clin Lymphoma Myeloma Leuk. 2022;22(4):e241–e249. doi:10.1016/j.clml.2021.10.001
   PubMed Web of Science ®Google Scholar
• Sonneveld P, Verelst SG, Lewis P, et al. Review of health-related quality of life data in multiple myeloma patients treated with novel agents. Leukemia. 2013;27(10):1959–1969. doi:10.1038/leu.2013.185
   PubMed Web of Science ®Google Scholar
• Robinson D, Esseltine DL, Regnault A, et al. The influence of baseline characteristics and disease stage on health-related quality of life in multiple myeloma: findings from six randomized controlled trials. Br J Haematol. 2016;174(3):368–381. doi:10.1111/bjh.14058
   PubMed Web of Science ®Google Scholar
• Kongsgaard Nielsen L, Jarden M, Lykkegaard Andersen C, et al. A systematic review of health-related quality of life in longitudinal studies of myeloma patients. Eur J Haematol. 2017;99(1):3–17. doi:10.1111/ejh.12882
   Web of Science ®Google Scholar
• Osborne TR, Ramsenthaler C, Siegert RJ, et al. What issues matter most to people with multiple myeloma and how well are we measuring them? A systematic review of quality of life tools. Eur J Haematol. 2012;89(6):437–457. doi:10.1111/ejh.12012
   PubMed Web of Science ®Google Scholar
• Kontodimopoulos N, Samartzis A, Papadopoulos AA, et al. Reliability and validity of the greek QLQ-C30 and QLQ-MY20 for measuring quality of life in patients with multiple myeloma. ScientificWorldJournal. 2012;2012:842867. doi:10.1100/2012/842867
   PubMedGoogle Scholar
• Lee SE, Kim JH, Jeon YW, et al. Impact of extramedullary plasmacytomas on outcomes according to treatment approach in newly diagnosed symptomatic multiple myeloma. Ann Hematol. 2015;94(3):445–452. doi:10.1007/s00277-014-2216-8
   PubMed Web of Science ®Google Scholar
• Seitzler S, Finley-Oliver E, Simonelli C, et al. Quality of life in multiple myeloma : considerations and recommendations quality of life in multiple myeloma : considerations and recommendations. Expert Rev Hematol. 2019;12(6):419–424. doi:10.1080/17474086.2019.1613886
   PubMed Web of Science ®Google Scholar
• King S, Exley J, Parks S, et al. The use and impact of quality of life assessment tools in clinical care settings for cancer patients, with a particular emphasis on brain cancer: insights from a systematic review and stakeholder consultations. Qual Life Res. 2016;25(9):2245–2256. doi:10.1007/s11136-016-1278-6
   PubMed Web of Science ®Google Scholar