Patient-reported outcomes with belantamab mafodotin, bortezomib, and dexamethasone versus daratumumab, bortezomib, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-7): results from a phase 3, open-label, randomised controlled trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00843989%3A_____%2F25%3AE0112092" target="_blank" >RIV/00843989:_____/25:E0112092 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/61988987:17110/25:A2603DKU

Výsledek na webu

<a href="https://doi.org/10.1016/S2352-3026(25)00163-2" target="_blank" >https://doi.org/10.1016/S2352-3026(25)00163-2</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/S2352-3026(25)00163-2" target="_blank" >10.1016/S2352-3026(25)00163-2</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Patient-reported outcomes with belantamab mafodotin, bortezomib, and dexamethasone versus daratumumab, bortezomib, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-7): results from a phase 3, open-label, randomised controlled trial

Popis výsledku v původním jazyce

Background: Belantamab mafodotin, bortezomib, and dexamethasone showed significant progression-free survival benefit compared with daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma in the phase 3 DREAMM-7 study. We aimed to evaluate the effect of belantamab mafodotin, bortezomib, and dexamethasone compared with daratumumab, bortezomib, and dexamethasone on health-related quality of life (HRQOL) using various patient-reported outcomes in patients who participated in DREAMM-7. Methods: This phase 3, open-label, randomised controlled trial, done at 142 hospitals in 20 countries included adult patients aged 18 years or older with relapsed or refractory multiple myeloma who received at least one previous line of therapy and progressed during or after their most recent treatment and had an Eastern Cooperative Oncology Group performance status of 0 to 2. Eligible patients were randomly assigned (1:1) by a central interactive response technology system to receive intravenous belantamab mafodotin (2·5 mg/kg once on day 1 of each 21-day cycle) or intravenous daratumumab (16 mg/kg once a week in cycles 1-3, every 3 weeks in cycles 4-8, and every 4 weeks in cycle 9 and beyond). Patients in both treatment groups also received subcutaneous bortezomib (1·3 mg/m2 on days 1, 4, 8, and 11 of 21-day cycles) and oral or intravenous dexamethasone (20 mg on the day of and day after bortezomib administration) for the first 8 cycles. Treatment continued until progressive disease, unacceptable toxic effects, withdrawal of consent, or death (whichever occurred first). Patient-reported outcomes were secondary and exploratory objectives. Secondary patient-reported outcome endpoints were change from baseline in HRQOL, as measured by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC QLQ-MY20, and maximum postbaseline score for each item attribute on the Patient-Reported Outcomes version of the Common Terminology Criter...

Název v anglickém jazyce

Patient-reported outcomes with belantamab mafodotin, bortezomib, and dexamethasone versus daratumumab, bortezomib, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-7): results from a phase 3, open-label, randomised controlled trial

Popis výsledku anglicky

Background: Belantamab mafodotin, bortezomib, and dexamethasone showed significant progression-free survival benefit compared with daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma in the phase 3 DREAMM-7 study. We aimed to evaluate the effect of belantamab mafodotin, bortezomib, and dexamethasone compared with daratumumab, bortezomib, and dexamethasone on health-related quality of life (HRQOL) using various patient-reported outcomes in patients who participated in DREAMM-7. Methods: This phase 3, open-label, randomised controlled trial, done at 142 hospitals in 20 countries included adult patients aged 18 years or older with relapsed or refractory multiple myeloma who received at least one previous line of therapy and progressed during or after their most recent treatment and had an Eastern Cooperative Oncology Group performance status of 0 to 2. Eligible patients were randomly assigned (1:1) by a central interactive response technology system to receive intravenous belantamab mafodotin (2·5 mg/kg once on day 1 of each 21-day cycle) or intravenous daratumumab (16 mg/kg once a week in cycles 1-3, every 3 weeks in cycles 4-8, and every 4 weeks in cycle 9 and beyond). Patients in both treatment groups also received subcutaneous bortezomib (1·3 mg/m2 on days 1, 4, 8, and 11 of 21-day cycles) and oral or intravenous dexamethasone (20 mg on the day of and day after bortezomib administration) for the first 8 cycles. Treatment continued until progressive disease, unacceptable toxic effects, withdrawal of consent, or death (whichever occurred first). Patient-reported outcomes were secondary and exploratory objectives. Secondary patient-reported outcome endpoints were change from baseline in HRQOL, as measured by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC QLQ-MY20, and maximum postbaseline score for each item attribute on the Patient-Reported Outcomes version of the Common Terminology Criter...

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30205 - Hematology

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Lancet Haematology

ISSN

2352-3026

e-ISSN

2352-3026

Svazek periodika

12

Číslo periodika v rámci svazku

8

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

1

Strana od-do

e599-e610

Kód UT WoS článku

001548994400023

EID výsledku v databázi Scopus

2-s2.0-105010931830