Efficacy and safety of single-agent belantamab mafodotin versus pomalidomide plus low-dose dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-3): a phase 3, open-label, randomised study.
Abstract | BACKGROUND:
Multiple myeloma remains incurable, and heavily pretreated patients with relapsed or refractory disease have few good treatment options. Belantamab mafodotin showed promising results in a phase 2 study of patients with relapsed or refractory multiple myeloma at second or later relapse and a manageable adverse event profile. We aimed to assess the safety and efficacy of belantamab mafodotin in a phase 3 setting. METHODS: In the DREAMM-3 open-label phase 3 study, conducted at 108 sites across 18 countries, adult patients were enrolled who had confirmed multiple myeloma (International Myeloma Working Group criteria), ECOG performance status of 0-2, had received two or more previous lines of therapy, including two or more consecutive cycles of both lenalidomide and a proteasome inhibitor, and progressed on, or within, 60 days of completion of the previous treatment. Participants were randomly allocated using a central interactive response technology system (2:1) to receive belantamab mafodotin 2·5 mg/kg intravenously every 21 days, or oral pomalidomide 4·0 mg daily (days 1-21) and dexamethasone 40·0 mg (20·0 mg if >75 years) weekly in a 28-day cycle. Randomisation was stratified by previous anti-CD38 therapy, International Staging System stage, and number of previous therapies. The primary endpoint was progression-free survival in all patients who were randomly allocated. The safety population included all randomly allocated patients who received one or more doses of study treatment. This trial is registered with ClinicalTrials.gov, NCT04162210, and is ongoing. Data cutoff for this analysis was Sept 12, 2022. FINDINGS: INTERPRETATION:
Belantamab mafodotin was not associated with statistically improved progression-free survival compared with standard-of-care, but there were no new safety signals associated with its use. Belantamab mafodotin is being tested in combination regimens for relapsed or refractory multiple myeloma. FUNDING: GSK (study number 207495).
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Authors | Meletios Athanasios Dimopoulos, Vania T M Hungria, Atanas Radinoff, Sosana Delimpasi, Gabor Mikala, Tamas Masszi, Jian Li, Marcelo Capra, Angelo Maiolino, Vasiliki Pappa, Dominik Chraniuk, Iurii Osipov, Xavier Leleu, Michael Low, Morio Matsumoto, Neal Sule, Mary Li, Astrid McKeown, Wei He, Shelley Bright, Brooke Currie, Sue Perera, Julia Boyle, Sumita Roy-Ghanta, Joanna Opalinska, Katja Weisel |
Journal | The Lancet. Haematology
(Lancet Haematol)
Vol. 10
Issue 10
Pg. e801-e812
(Oct 2023)
ISSN: 2352-3026 [Electronic] England |
PMID | 37793771
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
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Copyright | Copyright © 2023 Elsevier Ltd. All rights reserved. |
Chemical References |
- belantamab mafodotin
- Dexamethasone
- pomalidomide
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Topics |
- Aged
- Female
- Humans
- Male
- Anemia
(drug therapy)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects)
- Dexamethasone
(therapeutic use)
- Multiple Myeloma
(drug therapy)
- Neoplasm Recurrence, Local
(drug therapy)
- Middle Aged
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