Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study
Sagar Lonial, Hans C Lee, Ashraf Badros, Suzanne Trudel, Ajay K Nooka, Ajai Chari, Al-Ola Abdallah, Natalie Callander, Nikoletta Lendvai, Douglas Sborov, Attaya Suvannasankha, Katja Weisel, Lionel Karlin, Edward Libby, Bertrand Arnulf, Thierry Facon, Cyrille Hulin, K Martin Kortum, Paula Rodriguez-Otero, Saad Z Usmani Show all
The Lancet Oncology | ELSEVIER SCIENCE INC | Published : 2020
BACKGROUND: Belantamab mafodotin (GSK2857916), an immunoconjugate targeting B-cell maturation antigen, showed single-agent activity in the phase 1 DREAMM-1 study in heavily pre-treated patients with relapsed or refractory multiple myeloma. We further investigated the safety and activity of belantamab mafodotin in the DREAMM-2 study. METHODS: DREAMM-2 is an open-label, two-arm, phase 2 study done at 58 multiple myeloma specialty centres in eight countries. Patients (aged ≥18 years) with relapsed or refractory multiple myeloma with disease progression after three or more lines of therapy and who were refractory to immunomodulatory drugs and proteasome inhibitors, and refractory or intolerant (..View full abstract
This study was funded by GlaxoSmithKline. GlaxoSmithKline contributed to study design, implementation, data collection, interpretation and analysis. Medical writing support was funded by GlaxoSmithKline. We thank the ophthalmology and optometry colleagues who provide ophthalmic examinations to patients enrolled in the study, and Jeff Jackson, Karrie Wang, Joe Kovach, Kaytlyn Nungesser, and Alessandra Tosolini. Medical writing support was provided by Fiona Woodward, Chloe Stevenson, and Sarah Hauze, of Fishawack Indicia, UK, funded by GlaxoSmithKline. Drug linker technology was licensed from Seattle Genetics (Bothell, WA, USA) and the monoclonal antibody was produced with POTELLIGENT Technology licensed from BioWa (Princeton, NJ, USA). RP is supported by the National Institute for Health Research (NIHR) University College London Hospitals (UCLH) Biomedical Research Centre and this trial was supported in part by the NIHR UCLH Clinical Research Facility and the Cancer Research UK Experimental Cancer Medicine Centre.