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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
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
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.
DOI: 10.1016/S0140-6736(19)32556-5
PubMed URL:
ISSN: 0140-6736
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:
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

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