Patient‐reported health‐related quality of life from the phase III TOURMALINE‐MM1 study of ixazomib‐lenalidomide‐dexamethasone versus placebo‐lenalidomide‐dexamethasone in relapsed/refractory multiple myeloma

Leleu, Xavier; Masszi, Tamás; Bahlis, Nizar J.; Viterbo, Luísa; Baker, Bart; Gimsing, Peter; Maisnar, Vladimír; Samoilova, Olga; Rosiñol, Laura; Langer, Christian; Song, Kevin; Izumi, Tohru; Cleeland, Charles S.; Berg, Deborah; Lin, Huamao Mark; Zhu, Yanyan; Skácel, Tomáš; Moreau, Philippe; Richardson, Paul G.

doi:10.1002/ajh.25134

Cited by 44 publications

(33 citation statements)

References 36 publications

(91 reference statements)

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“…The assumption for MCAR missing data mechanism could not be confirmed in the included studies, where this aspect was investigated. In the two studies where a graphical approach was used (Stewart et al , ; Leleu et al , ), a slightly different pattern of change in global quality of life score over time was found for patients dropping out earlier compared to patients staying in the study for the whole period, but the differences were not statistically significant or clinically meaningful.…”

Section: Discussionmentioning

confidence: 98%

“…*Based on figure 1 in Gulbrandsen et al (2001). †Calculated on basis of table S2 in Leleu et al (2018).…”

Section: Discussionmentioning

confidence: 99%

“…The number of questionnaires is presented in Table I. The highest proportion of monotone NR was seen in the TOURMALINE study (Leleu et al, 2018): 99% in the lenalidomide-dexamethasone group and 98% in the ixazomib-lenalidomide-dexamethasone group. The PRO data results in that study were collected at a specified cut-off date and some patients are still in follow-up.…”

Section: Magnitude Of Monotone Non-responsesmentioning

confidence: 99%

“…The methods applied are presented in Table I. In the ASPIRE and TOURMALINE studies, a graphical approach was used to explore patterns of monotone NR (Stewart et al, 2016;Leleu et al, 2018). Multiple imputation was used to test the robustness of the PRO results in three studies (Lee et al, 2008;Gimsing et al, 2010;Waage et al, 2010).…”

Section: Statistical Handling Of Intermittent and Monotone Non-responsesmentioning

confidence: 99%

“…peripheral neuropathy and fatigue (Mateos, 2010;Molassiotis et al, 2011;Richardson et al, 2012;Boland et al, 2013). Treatment decision-making in MM is complex and involves factors such as disease stage, prognostic risk stratification, severity of myeloma symptoms and complications, expected progression-free survival and toxicity profiles of available treatment regimens, as well as the patients 0 comorbidities and preferences concerning goals in life, convenience in drug administration and HRQoL during and after treatment (Deber et al, 2007;Mikhael et al, 2013;Tariman et al, 2014a,b;Leleu et al, 2015;Laubach et al, 2016).…”

mentioning

confidence: 99%

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Methodological aspects of health‐related quality of life measurement and analysis in patients with multiple myeloma

et al. 2019

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Summary Multiple myeloma (MM) is an incurable but treatment‐sensitive cancer. For most patients, this means treatment with multiple lines of anti‐myeloma therapy and a life with disease‐ and treatment‐related symptoms and complications. Health‐related quality of life (HRQoL) issues play an important role in treatment decision‐making. Methodological challenges in longitudinal HRQoL measurements and analyses have been identified, including non‐responses (NR) to scheduled questionnaires. Publications were identified for inclusion in a systematic review of longitudinal HRQoL studies in MM, focussing on methodological aspects of HRQoL measurement and analysis. Diversity in timing of HRQoL data collection and applied statistical methods were noted. We observed a high rate of NR, but the impact of NR was investigated in only 8/23 studies. Thus, evidence‐based knowledge of HRQoL in patients with MM is compromised. To improve quality of HRQoL results and their implementation in daily practice, future studies should follow established guidelines.

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Section: Discussionmentioning

confidence: 98%

“…*Based on figure 1 in Gulbrandsen et al (2001). †Calculated on basis of table S2 in Leleu et al (2018).…”

Section: Discussionmentioning

confidence: 99%

Section: Magnitude Of Monotone Non-responsesmentioning

confidence: 99%

Section: Statistical Handling Of Intermittent and Monotone Non-responsesmentioning

confidence: 99%

mentioning

confidence: 99%

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Methodological aspects of health‐related quality of life measurement and analysis in patients with multiple myeloma

et al. 2019

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Treatment and disease‐related complications in multiple myeloma: Implications for survivorship

Chakraborty

Majhail

2020

American J Hematol

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New treatments have transformed multiple myeloma into a chronic disease. Hence, optimal management of treatment and disease‐related complications remains a critical component of survivorship care. Survivorship care model in cancers requiring a fixed‐duration therapy may not be applicable to myeloma, since patients are exposed to multiple lines of continuous therapy along the disease trajectory. The two most common therapy‐related causes of death, which require special consideration, are infection and second cancers. Identifying patients at a high risk of toxicities will facilitate individualized treatment selection and designing clinical trials for protective strategies targeting those patients. For example, prophylactic antibiotic or immunoglobulin replacement can be tested for primary prevention of infections in high‐risk patients. Long‐term follow up of ongoing trials and epidemiologic data will help identify the nature and trajectory of rare toxicities with a long latency, such as secondary cancers. Patients who are frail, have persistent renal insufficiency, and refractory to multiple lines of therapy need special attention regarding treatment toxicity and quality of life. In this review, we discuss the incidence, risk‐factors, and management of treatment and disease‐related complications in myeloma, discuss knowledge gaps and research priorities in this area, and propose a survivorship care model to improve health‐care delivery to a growing pool of myeloma survivors.

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Ixazomib combined with lenalidomide and dexamethasone chemotherapy for newly diagnosed multiple myeloma in China—Compared with bortezomib/lenalidomide/dexamethasone

et al. 2022

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Background To compare the response and safety of Ixazomib/Lenalidomide/Dexamethasone (IRd) and Bortezomib/Lenalidomide/Dexamethasone (VRd) treatment in newly diagnosed multiple myeloma (MM). Methods This was a single‐center retrospective analysis in Xiangtan Central Hospital. A total of 52 newly diagnosed MM patients from June 2019 to June 2021 were enrolled and divided into the IRd ( n = 21) and VRd ( n = 31) groups. After 4 cycles of chemotherapy, the best response and adverse events were recorded. Moreover, the progression‐free survival (PFS) and overall survival (OS) were calculated. Results Patients in IRd group and VRd group showed similar PFS (Log‐rank p = 0.70), OS (Log‐rank p = 0.61) and overall response rate (83.87% vs 90.48%, p = 0.803). In addition, patients in VRd group showed lower Eastern Cooperative Oncology Group scores ( p = 0.047), and higher incidence of peripheral sensory neuropathy (0.00% vs 19.35%, p = 0.032) than that of patients in IRd group. Conclusion Compared to VRd regimen, IRd had the similar efficacy, better safety, and may be more convenient for patients with poor basic condition for newly diagnosed MM. This study provides an insight for physicians to use IRd as first‐line treatment in MM.

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Patient‐reported health‐related quality of life from the phase III TOURMALINE‐MM1 study of ixazomib‐lenalidomide‐dexamethasone versus placebo‐lenalidomide‐dexamethasone in relapsed/refractory multiple myeloma

Cited by 44 publications

References 36 publications

Methodological aspects of health‐related quality of life measurement and analysis in patients with multiple myeloma

Methodological aspects of health‐related quality of life measurement and analysis in patients with multiple myeloma

Treatment and disease‐related complications in multiple myeloma: Implications for survivorship

Ixazomib combined with lenalidomide and dexamethasone chemotherapy for newly diagnosed multiple myeloma in China—Compared with bortezomib/lenalidomide/dexamethasone

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