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Title: | Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. |
Epworth Authors: | Prince, Miles |
Other Authors: | Attal, Michel Richardson, Paul Rajkumar, S.Vincent San-Miguel, Jesus Beksac, Meral Spicka, Ivan Leleu, Xavier Schjesvold, Fredrik Moreau, Philippe Dimopoulos, Meletios Huang, Jeffrey Minarik, Jiri Cavo, Michele Macé, Sandrine Corzo, Kathryn Campana, Frank Le-Guennec, Solenn Dubin, Franck Anderson, Kenneth study group, ICARIA-MM |
Keywords: | Isatuximab Pomalidomide Low-Dose Dexamethasone Multiple Myeloma Relapsed and Refractory Multiple Myeloma (ICARIA-MM) Phase 3 study Monoclonal Antibody Antitumour Activity Progression-Free Survival (PFS) Median Progression-Free Survival Treatment-Emergent Adverse Events Proteasome Inhibitor Lenalidomide Intention-to-Treat Population Interactive response technology Epworth Centre for Immunotherapies and Snowdome Laboratories Molecular Oncology and Cancer Immunology Cancer Services Clinical Institute, Epworth HealthCare, Victoria, Australia |
Issue Date: | Nov-2019 |
Publisher: | Elsevier |
Citation: | Lancet (London, England), 394(10214), 2096–2107. |
Abstract: | Isatuximab is a monoclonal antibody that binds a specific epitope on the human CD38 receptor and has antitumour activity via multiple mechanisms of action. In a previous phase 1b study, around 65% of patients with relapsed and refractory multiple myeloma achieved an overall response with a combination of isatuximab with pomalidomide and low-dose dexamethasone. The aim of this study was to determine the progression-free survival benefit of isatuximab plus pomalidomide and dexamethasone compared with pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma. |
URI: | http://hdl.handle.net/11434/2051 |
DOI: | 10.1016/S0140-6736(19)32556-5 |
PubMed URL: | https://pubmed.ncbi.nlm.nih.gov/31735560/ |
ISSN: | 0140-6736 1474-547X |
Journal Title: | The Lancet |
Type: | Journal Article |
Affiliated Organisations: | Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France. Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA. Electronic address: paul_richardson@dfci.harvard.edu. Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA. Clinical and Translational Medicine, Clínica Universidad de Navarra, Navarra, CIMA, IDISNA, CIBER-ONC, Pamplona, Spain. Department of Hematology, Ankara University, Ankara, Turkey. 1st Department of Medicine, Department of Hematology, First Faculty of Medicine Charles University and General Hospital in Prague, Prague, Czech Republic. Department of Haematology, CHU La Milétrie-Poitiers, Poitiers, France. Oslo Myeloma Center, Oslo University Hospital, Oslo, Norway; KG Jebsen Center for B cell malignancies, University of Oslo, Oslo, Norway. Hematology Department, CHU Nantes, Nantes, France. Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Athens, Greece. Department of Hematology, National Taiwan University Hospital, Taiwan. Department of Hemato-Oncology, Faculty of Medicine and Dentistry, Palacky University and University Hospital Olomouc, Olomouc, Czech Republic Department of Experimental, Diagnostic and Specialty Medicine, Seràgnoli Institute of Hematology, University of Bologna, Bologna, Italy. Sanofi Research And Development, Vitry-Sur-Seine, France. Sanofi-Genzyme Oncology, Cambridge, MA, USA. Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA. |
Type of Clinical Study or Trial: | Randomised, Multicentre, Open-label, Phase 3 Study |
Appears in Collections: | Cancer Services MOCI |
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