scholarly journals Health-related quality of life with idecabtagene vicleucel in relapsed and refractory multiple myeloma

2021 ◽  
Author(s):  
Michel Delforge ◽  
Nina Shah ◽  
Jesus F. San-Miguel ◽  
Julia Braverman ◽  
Devender S. Dhanda ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Myeloma ◽  
Physical Functioning ◽  
Health Related Quality ◽  
T Cell Therapy ◽  
Refractory Multiple Myeloma ◽  
Related Quality ◽  
Health Related ◽  
Eortc Qlq

Idecabtagene vicleucel (ide-cel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell therapy, showed deep, durable responses in patients with triple-class exposed (TCE) relapsed and refractory multiple myeloma (RRMM) in the phase 2 KarMMa trial. We assessed health-related quality of life (HRQoL) among KarMMa patients. EORTC QLQ-C30, EORTC QLQ-MY20, and EQ-5D-5L were given at screening, baseline (≤72 hours prior to or same day as lymphodepletion), day of ide-cel treatment, and after ide-cel treatment. Mean changes from baseline that exceeded the predetermined threshold of minimally important difference were deemed clinically meaningful. Proportions of patients experiencing clinically meaningful changes in HRQoL were assessed using within-patient change thresholds. Time to stable improvement (≥2 consecutive visits with clinically meaningful HRQoL improvements) was analyzed using the Kaplan-Meier method. 126/128 (98%) patients treated with ide-cel were included in the HRQoL analysis. Pretreatment baseline RRMM burden was high and meaningfully worse than the age- and sex-weighted general population. Statistically significant and clinically meaningful improvements from baseline were observed by month 1 for pain (−8.9) and disease symptoms (−10.2), and by month 2 for fatigue (−7.2), physical functioning (+6.1), cognitive functioning (+6.7), and global health status/QoL (+8.0). Clinically meaningful improvements in fatigue, pain, and physical functioning were most prominent at months 9, 12, and 18, respectively, and were sustained through 15 to 18 months after ide-cel treatment. For TCE patients with RRMM with a poor prognosis and few treatment options, a single ide-cel infusion provides early, sustained, statistically significant, and clinically meaningful improvements in HRQoL.

scholarly journals Health-related quality of life in Croatian general population and multiple myeloma patients assessed by the EORTC QLQ-C30 and EORTC QLQ-MY20 questionnaires

2019 ◽  
Vol 53 (3) ◽  
pp. 337-347 ◽  
Author(s):  
Sanja Ledinski Ficko ◽  
Vlatko Pejsa ◽  
Vesna Zadnik
Keyword(s):  
Quality Of Life ◽  
Multiple Myeloma ◽  
General Population ◽  
Health Related Quality ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq ◽  
The Impact

Abstract Background The impact of disease and treatment on the patient’s overall well-being and functioning is a topic of growing interest in clinical research and practice. The aim of this study is to obtain reference data on quality of life of Croatian general population. Further, we aim to assess the impact of the disease and its primary systemic treatment on their health related quality of life (HrQoL) in multiple myeloma (MM) patients. Patients and methods Participants for the first part of the study were randomly selected from adult Croatian population. In the clinical part of the study MM patients were included as prospectively diagnosed within two years in two major Croatian haematological centres. The EORTC QLQ-C30 in both trials and QLQ-MY20 in MM patients only were applied for HrQoL assessment. Results Gender, age and place of residence have great impact on quality of life scores in Croatian population. The MM patients at the time of diagnosis have lower QLQ-C30 scores for global quality of life, functional and symptom scale scores, as well as single items. The type of disease followed by the choice of therapy options are important HrQoL determinants. Conclusions The norm values available now for Croatian population will help to interpret HrQoL for clinicians and aid in planning cancer care interventions. This study identified treatment effect consistent with those from other observational studies and provided new data on HrQoL across two different treatment choices for MM patients.

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