Impact of Elotuzumab Plus Pomalidomide/Dexamethasone on Health-related Quality of Life for Patients With Relapsed/Refractory Multiple Myeloma: Final Data From the Phase 2 ELOQUENT-3 Trial.


Journal

HemaSphere
ISSN: 2572-9241
Titre abrégé: Hemasphere
Pays: United States
ID NLM: 101740619

Informations de publication

Date de publication:
Mar 2023
Historique:
received: 19 09 2022
accepted: 09 01 2023
entrez: 2 3 2023
pubmed: 3 3 2023
medline: 3 3 2023
Statut: epublish

Résumé

Triplet regimens containing immunomodulatory drugs and proteasome inhibitors (PIs) have improved outcomes and extended survival for patients with relapsed/refractory multiple myeloma (RRMM). We evaluated updated health-related quality of life (HRQoL) findings from the phase 2 ELOQUENT-3 clinical trial (NCT02654132) after 4 years of treatment with elotuzumab plus pomalidomide and dexamethasone (EPd) and assessed the impact of the addition of elotuzumab on patients' HRQoL. HRQoL was assessed as an exploratory endpoint using the MD Anderson Symptom Inventory for Multiple Myeloma (MDASI-MM), which evaluates symptom severity, symptom interference, and HRQoL, and the 3-level EQ-5D, a patient-reported measure of health utility and general health. Statistical analyses included descriptive responder, longitudinal mixed-model, and time-to-first-deterioration (TTD) analyses using prespecified minimally important differences and responder definitions. Of 117 randomized patients, 106 (EPd, n = 55; pomalidomide and dexamethasone [Pd], n = 51) were eligible for inclusion in HRQoL analyses. Completion rates at almost all on-treatment visits were ≥80%. The proportion of patients treated with EPd who improved or maintained stable HRQoL until cycle 13 ranged from 82% to 96% for MDASI-MM total symptom score and 64% to 85% for MDASI-MM symptom interference. Across measurements, there were no clinically meaningful differences in changes from baseline between treatment arms, and TTD was not significantly different for EPd versus Pd. In conclusion, HRQoL was not impacted by the addition of elotuzumab to Pd and did not significantly deteriorate in patients with RRMM previously treated with lenalidomide and a PI in ELOQUENT-3.

Identifiants

pubmed: 36860268
doi: 10.1097/HS9.0000000000000843
pmc: PMC9970270
doi:

Types de publication

Journal Article

Langues

eng

Pagination

e843

Informations de copyright

Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Hematology Association.

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Auteurs

Katja Weisel (K)

Department of Oncology, Hematology and BMT, University Medical Center of Hamburg-Eppendorf, Germany.

Meletios A Dimopoulos (MA)

National and Kapodistrian University of Athens School of Medicine, Athens, Greece.

Jesús San-Miguel (J)

Clínica Universidad de Navarra, CCUN, CIMA, IDISNA, CIBERONC, Pamplona, Spain.

Agne Paner (A)

Rush University Medical Center, Chicago, IL, USA.

Monika Engelhardt (M)

University Hospital of Freiburg, Faculty of Freiburg, Germany.

Fiona Taylor (F)

Adelphi Values, Boston, MA, USA.

Jennifer Lord-Bessen (J)

Bristol Myers Squibb, Princeton, NJ, USA.

Christine Yip (C)

Adelphi Values, Boston, MA, USA.

Mike Greenwood (M)

Adelphi Values, Bollington, UK.

Jackson Tang (J)

Bristol Myers Squibb, Princeton, NJ, USA.

Michele Cavo (M)

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Seràgnoli Institute of Hematology, Bologna, Italy.
DIMES, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, Bologna, Italy.

Classifications MeSH