Modification of belantamab mafodotin dosing to balance efficacy and tolerability in the DREAMM-7 and DREAMM-8 trials
Jazyk angličtina Země Spojené státy americké Médium print
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, randomizované kontrolované studie
PubMed
40763276
PubMed Central
PMC12657289
DOI
10.1182/bloodadvances.2025016949
PII: 546495
Knihovny.cz E-zdroje
- MeSH
- humanizované monoklonální protilátky MeSH
- lidé středního věku MeSH
- lidé MeSH
- mnohočetný myelom * farmakoterapie mortalita MeSH
- protinádorové látky * škodlivé účinky aplikace a dávkování terapeutické užití MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- belantamab mafodotin MeSH Prohlížeč
- humanizované monoklonální protilátky MeSH
- protinádorové látky * MeSH
Belantamab mafodotin (belamaf) combined with standard therapies demonstrated significant progression-free survival (PFS) and overall survival benefits in DREAMM-7 and PFS benefit in DREAMM-8 in relapsed/refractory multiple myeloma. Belamaf dose modifications managed adverse events, including belamaf-related ocular events. Ocular events included ocular adverse reactions (eg, dry eyes, photophobia, eye irritation) and protocol-mandated ophthalmic examination findings. Protocol-recommended dose modifications for ocular events were driven by ophthalmic examination findings and included belamaf dose delays until resolution and reductions. We used descriptive analyses to evaluate the impact of dose modifications on managing ocular events and treatment efficacy. In patients with normal baseline vision who were receiving treatment, dose modifications extended belamaf dosing intervals to a median of 8 to 12 weeks by 9 months; the prevalences of reduced vision to bilateral 20/50 or worse and ocular adverse reactions were highest in the first 3 months and remained low at later time points. The median time to resolution after grade ≥2 ophthalmic examination findings was 12 weeks. Rates of belamaf discontinuations due to ocular events were low. Almost all responders (partial response or better) required dose modifications. Most patients achieved a response before an extended (>2 cycles) dose delay; most who had not, subsequently achieved or deepened their response. In DREAMM-7 and DREAMM-8, the median PFS in patients with ≥1 dose delay of ≥12 weeks was 36.6 months and not reached, respectively. Ocular events were common but effectively managed with dose modifications, allowing for patients to remain on treatment and derive robust efficacy benefit. The trials were registered at www.clinicaltrials.gov as #NCT04246047 (DREAMM-7) and #NCT04484623 (DREAMM-8).
1st Faculty of Medicine Charles University and General Hospital Prague Czech Republic
Clínica São Germano São Paulo Brazil
Department of Hematology Liv Hospital Ankara İstinye University Ankara Turkey
Department of Internal Medicine Hematology and Oncology University Hospital Brno Brno Czech Republic
Department of Medical and Surgical Sciences University of Bologna Bologna Italy
Department of Medical Oncology and Hematology Princess Margaret Cancer Centre Toronto ON Canada
Department of Medicine Korea University Seoul Republic of Korea
General Hospital Evangelismos Athens Greece
Gorodskaya Klinicheskaya Bol'nitsa Im S p Botkina Moscow Russia
Leningrad Regional Clinical Hospital Saint Petersburg Russia
Medical University of Łódź Łódź Poland
Medical University of Lublin Lublin Poland
Royal Prince Alfred Hospital and University of Sydney Camperdown NSW Australia
St Vincent's Hospital Melbourne University of Melbourne Melbourne VIC Australia
Sungkyunkwan University Samsung Medical Center Seoul Republic of Korea
The 1st Affiliated Hospital of Soochow University Jiangsu China
The Royal North Shore Hospital Sydney NSW Australia
Universidade da Região de Joinville and Centro de Hematologia e Oncologia Joinville Brazil
Zobrazit více v PubMed
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A study of belantamab mafodotin administered in combination with lenalidomide and dexamethasone (BRd) versus daratumumab, lenalidomide, and dexamethasone (DRd) in participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (TI-NDMM) (DREAMM-10). ClinicalTrials.gov identifier: NCT06679101. Updated 6 August 2025. https://clinicaltrials.gov/study/NCT06679101
A study to investigate the safety and efficacy of belantamab for the treatment of multiple myeloma when used as monotherapy and in combination treatments (DREAMM-20). ClinicalTrials.gov identifier: NCT05714839. Updated 5 June 2025. https://clinicaltrials.gov/study/NCT05714839
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ClinicalTrials.gov
NCT04246047, NCT04484623