| Contributors: |
A Dimopoulos, Meletio; Beksac, Meral; Pour, Ludek; Delimpasi, Sosana; Vorobyev, Vladimir; Quach, Hang; Spicka, Ivan; Radocha, Jakub; Robak, Paweł; Kim, Kihyun; Cavo, Michele; Suzuki, Kazuhito; Wilkes, Jodie; Mcnamara, Simon; Phillips-Jones, Amy; Morris, Kristin; Pompilus Molly Purser, Farrah; Sule, Neal; Kremer, Brandon; Loubert, Angely; Bunod, Laurine; M'Hari, Manal; L Zhou, Xiaoou; Fulci, Giulia; Mateos, María-Victoria; Trudel, Suzanne; Ronson, Aaron; Alegre Amor, Adrian; Eterio Velasco Valdazo, Alberto; Cohen, Amo; Lim, Andrew; Sureda Balari, Anna; Sampol Mayol, Antonia; Chaidos, Aristeidi; Jurczyszyn, Artur; Perrot, Aurore; Augustson, Bradley; Besemer, Britta; Forsyth, Cecily; Suriu, Celia; Min, Chang-Ki; Lee, Cindy; Mo, Clifton; Kirtbaya, Dmitriy; Lee, Edwin; Hatzimichael, Eleftheria; Oguz Kozan, Esin; Gonzalez Garcia, Esther; Carrillo Cruz, Estrella; De Arriba De La Fuente, Felipe; Cengiz Seval, Guldane; Ozsan, Guner; Saydam, Guray; Sia, Hanlon; Hunter, Hannah; Handa, Hiroshi; Eom, Hyeon-Seok; Irving, Ian; Davydkin, Igor; Tsoran-Rosenthal, Inna; Avivi, Irit; Osipov, Iurii; Min Byun, Ja; Lee, Jaehoon; Czyz, Jaroslaw; De La Rubia Comos, Javier; Jung Lee, Je; Schiano De Colella, Jean-Marc; Berdeja, Jesu; Seok Kim, Jin; Simpson, Jock; Francisco Cordeiro Camargo, Johnny; Nishiwaki, Kaichi; Karunanithi, Kamaraj; Forwood, Kathryn; Sunami, Kazutaka; Fay, Keith; Boyd, Kevin; Kawamura, Koji; Anargyrou, Konstantino; Matsue, Kosei; Maria Fogliatto, Laura; Rosiñol Dachs, Laura; Dutka, Magdalena; Modiano, Manuel; Pitombeira De Lacerda, Marcelo; Del Carmen Martinez Chamorro, Maria; Victoria Mateos Manteca, Maria; Hughes, Marie; Munder, Marku; Kortuem, Martin; Claudio Da Via, Matteo; Jenner, Matthew; Martelli, Maurizio; Sinan Dal, Mehmet |
| Description: |
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 (2·5 mg/kg on day 1 of cycle 1 and 1·9 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 (1·3 mg/m2 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 ... |