What issues matter most to people with multiple myeloma and how well are we measuring them? A systematic review of quality of life tools

Osborne, Thomas R.; Ramsenthaler, Christina; Siegert, Richard J.; Edmonds, Polly; Schey, Stephen; Higginson, Irene J

doi:10.1111/ejh.12012

Cited by 70 publications

(101 citation statements)

References 63 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…28 This finding should also be considered in the context of the limitations of existing instruments. 29,30 The rates of serious adverse events, discontinuation of the study regimen because of adverse events, and death during the study period were similar in the two groups, and the only adverse event of grade 3 or higher for which there was at least a 5% difference between the ixazomib and placebo groups was thrombocytopenia, a known side effect of bortezomib and carfilzomib, 31,32 for which there were no apparent clinical sequelae. No cardiac, renal, or respiratory safety signals were associated with the use of ixazomib.…”

Section: Discussionmentioning

confidence: 86%

Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma

et al. 2016

View full text Add to dashboard Cite

BACKGROUNDIxazomib is an oral proteasome inhibitor that is currently being studied for the treatment of multiple myeloma. METHODSIn this double-blind, placebo-controlled, phase 3 trial, we randomly assigned 722 patients who had relapsed, refractory, or relapsed and refractory multiple myeloma to receive ixazomib plus lenalidomide-dexamethasone (ixazomib group) or placebo plus lenalidomidedexamethasone (placebo group). The primary end point was progression-free survival. RESULTSProgression-free survival was significantly longer in the ixazomib group than in the placebo group at a median follow-up of 14.7 months (median progression-free survival, 20.6 months vs. 14.7 months; hazard ratio for disease progression or death in the ixazomib group, 0.74; P = 0.01); a benefit with respect to progression-free survival was observed with the ixazomib regimen, as compared with the placebo regimen, in all prespecified patient subgroups, including in patients with high-risk cytogenetic abnormalities. The overall rates of response were 78% in the ixazomib group and 72% in the placebo group, and the corresponding rates of complete response plus very good partial response were 48% and 39%. The median time to response was 1.1 months in the ixazomib group and 1.9 months in the placebo group, and the corresponding median duration of response was 20.5 months and 15.0 months. At a median follow-up of approximately 23 months, the median overall survival has not been reached in either study group, and follow-up is ongoing. The rates of serious adverse events were similar in the two study groups (47% in the ixazomib group and 49% in the placebo group), as were the rates of death during the study period (4% and 6%, respectively); adverse events of at least grade 3 severity occurred in 74% and 69% of the patients, respectively. Thrombocytopenia of grade 3 and grade 4 severity occurred more frequently in the ixazomib group (12% and 7% of the patients, respectively) than in the placebo group (5% and 4% of the patients, respectively). Rash occurred more frequently in the ixazomib group than in the placebo group (36% vs. 23% of the patients), as did gastrointestinal adverse events, which were predominantly low grade. The incidence of peripheral neuropathy was 27% in the ixazomib group and 22% in the placebo group (grade 3 events occurred in 2% of the patients in each study group). Patient-reported quality of life was similar in the two study groups. CONCLUSIONSThe addition of ixazomib to a regimen of lenalidomide and dexamethasone was associated with significantly longer progression-free survival; the additional toxic effects with this all-oral regimen were limited. (Funded by Millennium Pharmaceuticals; TOURMALINE-MM1 ClinicalTrials.gov number, NCT01564537.)

show abstract

Section: Discussionmentioning

confidence: 86%

Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma

et al. 2016

View full text Add to dashboard Cite

show abstract

“…23 for specific use in MM, and the general health-related EQ-5D HRQoL questionnaire that converts five dimensions of patient-reported, current-day health status into a "health utility" score (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). 26 These three questionnaires have been validated and extensively used in MM patients, [27][28][29][30][31][32][33] and can be completed in a few minutes. 34,35 Domains to focus on were chosen following a workshop discussion with specialists, based on perceived clinical relevance and on multivariate regression analysis against the EQ-5D utility index.…”

Section: Methodsmentioning

confidence: 99%

Pomalidomide and Low-Dose Dexamethasone Improves Health-Related Quality of Life and Prolongs Time to Worsening in Relapsed/Refractory Patients With Multiple Myeloma Enrolled in the MM-003 Randomized Phase III Trial

Weisel

Dimopoulos

Song

et al. 2015

Clinical Lymphoma Myeloma and Leukemia

View full text Add to dashboard Cite

“…Patients completed the questionnaires at several time points: baseline; at the end of Cycle 1 (after 4 weeks of treatment with Rd and after 6 weeks of treatment with MPT); after 3, 6, 12, and 18 months of treatment; and at study discontinuation. These questionnaires are among the most extensively validated in MM 36 and can be easily completed with minimal patient burden. 37,38 The analysis focused on the EQ-5D utility value and six pre-selected and clinically relevant HRQoL domains: two from the QLQ-MY20 (Disease Symptoms and Side Effects of Treatment); and four from the QLQ-C30 (Global Health Status, Physical Functioning, Fatigue, and Pain).…”

Section: Hrqol Assessmentsmentioning

confidence: 99%

Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide

et al. 2015

View full text Add to dashboard Cite

The randomized pivotal phase III FIRST trial (Frontline Investigation of lenalidomide/dexamethasone [Rev/Dex] versus Standard Thalidomide; IFM 2007-01/ MM-020; clinicaltrials.gov identifier: 00689936; EudraCT No. 2007-004823-39) compared the efficacy and safety of Rd, administered continuously until progressive disease (PD) or for a fixed 18-month duration (Rd18), with MPT given for 18 months in NDMM patients who were aged 65 years or over, or who were aged under 65 years and ineligible for stem cell transplantation. Continuous Rd showed improved progression-free survival (PFS) and overall survival (OS) benefit at interim analysis compared with MPT. 19 Although extending survival is clearly the ultimate treatment ©2015 Ferrata Storti Foundation. This is an open-access paper. doi:10.3324/haematol.2014 The online version of this article has a Supplementary Appendix. Manuscript received on November 14, 2014. Manuscript accepted on March 6, 2015 We compared the health-related quality-of-life of patients with newly diagnosed multiple myeloma aged over 65 years or transplant-ineligible in the pivotal, phase III FIRST trial. Patients received: i) continuous lenalidomide and low-dose dexamethasone until disease progression; ii) fixed cycles of lenalidomide and low-dose dexamethasone for 18 months; or iii) fixed cycles of melphalan, prednisone, thalidomide for 18 months. Data were collected using the validated questionnaires (QLQ-MY20, QLQ-C30, and EQ-5D). The analysis focused on the EQ-5D utility value and six domains pre-selected for their perceived clinical relevance. Lenalidomide and low-dose dexamethasone, and melphalan, prednisone, thalidomide improved patients' health-related quality-of-life from baseline over the duration of the study across all pre-selected domains of the QLQ-C30 and EQ-5D. In the QLQ-MY20, lenalidomide and low-dose dexamethasone demonstrated a significantly greater reduction in the Disease Symptoms domain compared with melphalan, prednisone, thalidomide at Month 3, and significantly lower scores for QLQ-MY20 Side Effects of Treatment at all post-baseline assessments except Month 18. Linear mixed-model repeatedmeasures analyses confirmed the results observed in the cross-sectional analysis. Continuous lenalidomide and low-dose dexamethasone delays disease progression versus melphalan, prednisone, thalidomide and has been associated with a clinically meaningful improvement in health-related quality-of-life. These results further establish continuous lenalidomide and low-dose dexamethasone as a new standard of care for initial therapy of myeloma by demonstrating superior health-related quality-of-life during treatment, compared with melphalan, prednisone, thalidomide.Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide [20][21][22][23] In this population, treatment objectives should be to improve disease management by delaying disease progression, optimizing re...

show abstract

What issues matter most to people with multiple myeloma and how well are we measuring them? A systematic review of quality of life tools

Cited by 70 publications

References 63 publications

Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma

Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma

Pomalidomide and Low-Dose Dexamethasone Improves Health-Related Quality of Life and Prolongs Time to Worsening in Relapsed/Refractory Patients With Multiple Myeloma Enrolled in the MM-003 Randomized Phase III Trial

Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide

Contact Info

Product

Resources

About