Patient-reported outcomes with belantamab mafodotin, pomalidomide, and dexamethasone versus bortezomib, pomalidomide, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-8): a phase 3, open-label, randomised controlled trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00179906%3A_____%2F25%3A10505584" target="_blank" >RIV/00179906:_____/25:10505584 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11110/25:10505584 RIV/00216208:11150/25:10505584 RIV/65269705:_____/25:00082954 RIV/00064165:_____/25:10505584

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=SpcGXRoGtl" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=SpcGXRoGtl</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/S2352-3026(25)00256-X" target="_blank" >10.1016/S2352-3026(25)00256-X</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Patient-reported outcomes with belantamab mafodotin, pomalidomide, and dexamethasone versus bortezomib, pomalidomide, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-8): a phase 3, open-label, randomised controlled trial

Popis výsledku v původním jazyce

Background: In the DREAMM-8 trial, belantamab mafodotin, pomalidomide, and dexamethasone demonstrated a statistically significant reduction in the risk of progression or death compared with bortezomib, pomalidomide, and dexamethasone in lenalidomide-exposed patients with relapsed or refractory multiple myeloma. We present patient-reported outcomes from this trial. Methods: This phase 3, open-label, randomised controlled trial was done in 95 sites in 18 countries. Eligible patients were adults aged 18 years or older with relapsed or refractory multiple myeloma per International Myeloma Working Group criteria, an Eastern Cooperative Oncology Group performance status of 0-2, and previous treatment with at least one line of therapy that included lenalidomide. Patients were randomly assigned (1:1) by a central interactive response technology system to receive 28-day cycles of intravenous belantamab mafodotin (2&lt;middle dot&gt;5 mg/kg on day 1 of cycle 1 and 1&lt;middle dot&gt;9 mg/kg on day 1 of cycle 2 onward) combined with oral pomalidomide (4 mg on days 1 to 21) and oral dexamethasone (40 mg on days 1, 8, 15, and 22; belantamab mafodotin group) or 21-day cycles of subcutaneous bortezomib (1&lt;middle dot&gt;3 mg/m(2) on days 1, 4, 8, and 11 of cycles 1-8 and days 1 and 8 of cycle 9 onward) combined with pomalidomide and dexamethasone at the same doses and schedules as the belantamab mafodotin group; bortezomib group). Treatment continued until the occurrence of progressive disease, unacceptable adverse effects, withdrawal of consent, or death (whichever occurred first). Secondary patient-reported outcome endpoints were change from baseline in health-related quality of life (HRQOL), measured by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, EORTC QLQ-MY20, and Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE). Ocular Surface Disease Index and Functional Assessment of Chronic Illness Therapy-Item GP5 results were assessed similarly as exploratory endpoints. EORTC QLQ-C30 and EORTC QLQ-MY20 disease symptom domain results were analysed in the intent-to-treat population, and PRO-CTCAE results were analysed in the safety population (patients who received at least one dose of study treatment). For all patient-reported outcome assessments, proportions included the number and percentage of patients with available data, and changes from baseline were summarised as means with 95% CIs at each timepoint. This trial was registered with ClinicalTrials.gov, NCT04484623, and is ongoing. Findings: Between Oct 12, 2020, and Dec 26, 2022, 382 patients were assessed for eligibility. 80 patients were excluded and 302 patients were enrolled and randomly assigned to either the belantamab mafodotin group (n=155) or bortezomib group (n=147). The median age in the whole population was 66&lt;middle dot&gt;1 years (SD 9&lt;middle dot&gt;31). 181 (60%) of 302 patients were male and 260 (86%) were White. At the primary analysis data cutoff (Jan 29, 2024), median follow-up was 21&lt;middle dot&gt;8 months (IQR 13&lt;middle dot&gt;2-27&lt;middle dot&gt;6). For all patient-reported outcome assessments during treatment, compliance was at least 90% for most visits within the first year. Change from baseline in EORTC QLQ-C30 and QLQ-MY20 domain scores remained stable in both treatment groups over time, with a consistently greater proportion of patients in the belantamab mafodotin group than in the bortezomib group experiencing meaningful improvement (&gt;= 10 points) at most visits. Side-effects were minimally bothersome in both groups within the first year of treatment. Blurred vision was the adverse event most commonly reported as severe or very severe (63 [43%] of 146 patients in the belantamab mafodotin group and 13 [9%] of 139 patients in the bortezomib group), followed by fatigue (56 [38%] of patients in the belantamab mafodotin group and 49 [35%] of patients in the bortezomib group). No clear differences between groups were observed for other symptomatic adverse events. Interpretation: Patients with relapsed or refractory multiple myeloma treated with belantamab mafodotin, pomalidomide, and dexamethasone or bortezomib, pomalidomide, and dexamethasone reported stable HRQOL. Self-reported ocular adverse events were generally manageable and minimally bothersome within the first year of treatment. These findings indicate that belantamab mafodotin, pomalidomide, and dexamethasone is well tolerated, with little detriment to HRQOL, supporting its use in relapsed or refractory multiple myeloma.

Název v anglickém jazyce

Patient-reported outcomes with belantamab mafodotin, pomalidomide, and dexamethasone versus bortezomib, pomalidomide, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-8): a phase 3, open-label, randomised controlled trial

Popis výsledku anglicky

Background: In the DREAMM-8 trial, belantamab mafodotin, pomalidomide, and dexamethasone demonstrated a statistically significant reduction in the risk of progression or death compared with bortezomib, pomalidomide, and dexamethasone in lenalidomide-exposed patients with relapsed or refractory multiple myeloma. We present patient-reported outcomes from this trial. Methods: This phase 3, open-label, randomised controlled trial was done in 95 sites in 18 countries. Eligible patients were adults aged 18 years or older with relapsed or refractory multiple myeloma per International Myeloma Working Group criteria, an Eastern Cooperative Oncology Group performance status of 0-2, and previous treatment with at least one line of therapy that included lenalidomide. Patients were randomly assigned (1:1) by a central interactive response technology system to receive 28-day cycles of intravenous belantamab mafodotin (2&lt;middle dot&gt;5 mg/kg on day 1 of cycle 1 and 1&lt;middle dot&gt;9 mg/kg on day 1 of cycle 2 onward) combined with oral pomalidomide (4 mg on days 1 to 21) and oral dexamethasone (40 mg on days 1, 8, 15, and 22; belantamab mafodotin group) or 21-day cycles of subcutaneous bortezomib (1&lt;middle dot&gt;3 mg/m(2) on days 1, 4, 8, and 11 of cycles 1-8 and days 1 and 8 of cycle 9 onward) combined with pomalidomide and dexamethasone at the same doses and schedules as the belantamab mafodotin group; bortezomib group). Treatment continued until the occurrence of progressive disease, unacceptable adverse effects, withdrawal of consent, or death (whichever occurred first). Secondary patient-reported outcome endpoints were change from baseline in health-related quality of life (HRQOL), measured by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, EORTC QLQ-MY20, and Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE). Ocular Surface Disease Index and Functional Assessment of Chronic Illness Therapy-Item GP5 results were assessed similarly as exploratory endpoints. EORTC QLQ-C30 and EORTC QLQ-MY20 disease symptom domain results were analysed in the intent-to-treat population, and PRO-CTCAE results were analysed in the safety population (patients who received at least one dose of study treatment). For all patient-reported outcome assessments, proportions included the number and percentage of patients with available data, and changes from baseline were summarised as means with 95% CIs at each timepoint. This trial was registered with ClinicalTrials.gov, NCT04484623, and is ongoing. Findings: Between Oct 12, 2020, and Dec 26, 2022, 382 patients were assessed for eligibility. 80 patients were excluded and 302 patients were enrolled and randomly assigned to either the belantamab mafodotin group (n=155) or bortezomib group (n=147). The median age in the whole population was 66&lt;middle dot&gt;1 years (SD 9&lt;middle dot&gt;31). 181 (60%) of 302 patients were male and 260 (86%) were White. At the primary analysis data cutoff (Jan 29, 2024), median follow-up was 21&lt;middle dot&gt;8 months (IQR 13&lt;middle dot&gt;2-27&lt;middle dot&gt;6). For all patient-reported outcome assessments during treatment, compliance was at least 90% for most visits within the first year. Change from baseline in EORTC QLQ-C30 and QLQ-MY20 domain scores remained stable in both treatment groups over time, with a consistently greater proportion of patients in the belantamab mafodotin group than in the bortezomib group experiencing meaningful improvement (&gt;= 10 points) at most visits. Side-effects were minimally bothersome in both groups within the first year of treatment. Blurred vision was the adverse event most commonly reported as severe or very severe (63 [43%] of 146 patients in the belantamab mafodotin group and 13 [9%] of 139 patients in the bortezomib group), followed by fatigue (56 [38%] of patients in the belantamab mafodotin group and 49 [35%] of patients in the bortezomib group). No clear differences between groups were observed for other symptomatic adverse events. Interpretation: Patients with relapsed or refractory multiple myeloma treated with belantamab mafodotin, pomalidomide, and dexamethasone or bortezomib, pomalidomide, and dexamethasone reported stable HRQOL. Self-reported ocular adverse events were generally manageable and minimally bothersome within the first year of treatment. These findings indicate that belantamab mafodotin, pomalidomide, and dexamethasone is well tolerated, with little detriment to HRQOL, supporting its use in relapsed or refractory multiple myeloma.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30205 - Hematology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2025

Kód důvěrnosti údajů

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

Název periodika

The Lancet: Haematology

ISSN

2352-3026

e-ISSN

2352-3026

Svazek periodika

12

Číslo periodika v rámci svazku

11

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

11

Strana od-do

"e876"-"e886"

Kód UT WoS článku

001615702500001

EID výsledku v databázi Scopus

2-s2.0-105020993466