WHAT IS THIS SUMMARY ABOUT?: This summary describes the first analysis of the PERSEUS study, which looked at adults with multiple myeloma that had never been treated before, also called newly diagnosed multiple myeloma. Multiple myeloma is a type of cancer in the blood, specifically in plasma cells within the soft, spongy tissue in the center of most bones, called the bone marrow. Researchers wanted to see if adding daratumumab (D) to a standard treatment of three other medicines called VRd, which stands for bortezomib (V), lenalidomide (R), and dexamethasone (d), could stop the multiple myeloma from getting worse and help participants live longer without multiple myeloma.Half of the participants were assigned to the treatment plan with daratumumab; they received D-VRd during initial treatment phases (induction and consolidation), followed by daratumumab as well as lenalidomide (D-R) in the maintenance phase. The other half of participants received treatment without daratumumab; they received VRd induction and consolidation followed by lenalidomide alone (R) maintenance. In addition, all participants were able to receive an autologous stem cell transplant, a procedure used to further help reduce multiple myeloma. WHAT WERE THE RESULTS?: At the time of this analysis of PERSEUS, about 4 years after participants started the study, participants who received D-VRd treatment followed by D-R maintenance had a better response to treatment (as measured by specific markers of multiple myeloma) and were more likely to be alive and free from their multiple myeloma getting worse in comparison to participants who received VRd followed by R maintenance. Side effects (unwanted or undesirable effects of treatment) in both treatment groups were in line with the known side effects of daratumumab and VRd. WHAT DO THE RESULTS MEAN?: The results of the PERSEUS study showed that including daratumumab in D-VRd induction/consolidation and D-R maintenance was better for treating multiple myeloma than the current standard VRd treatment followed by R maintenance alone in adults with a new diagnosis of multiple myeloma who were also able to receive an autologous stem cell transplant. Of importance, there were no unexpected side effects in either group.Clinical Trial Registration: NCT02874742 (GRIFFIN) (ClinicalTrials.gov).

Ankara University Ankara Turkey

CHU de Toulouse IUCT O Université de Toulouse UPS Service d'Hématologie Toulouse France

Department of Hematology Amsterdam University Medical Center Vrije Universiteit Amsterdam Amsterdam The Netherlands

Department of Hematology ASST Spedali Civili di Brescia Brescia Italy

Department of Hematology Cancer Center Clínica Universidad de Navarra Pamplona Navarra Spain

Department of Hematology Careggi Hospital and University of Florence Firenze Italy

Department of Hematology EMN Erasmus MC Cancer Institute Rotterdam The Netherlands

Department of Hematology Hôpital Haut Lévêque University Hospital Pessac France

Department of Hematology Rigshospitalet Copenhagen Denmark

Department of Hematology Theagenion Cancer Hospital Thessaloniki Greece

Department of Hematooncology University Hospital Ostrava and Faculty of Medicine University of Ostrava Ostrava Czech Republic

Department of Internal Medicine 2 University Hospital Würzburg Würzburg Germany

Department of Medical Oncology and Hematology Cantonal Hospital St Gallen St Gallen Switzerland

Division of Hematology 1 AOU Città della Salute e della Scienza di Torino University of Torino and Department of Molecular Biotechnology and Health Sciences University of Torino Torino Italy

Division of Hematology IRCCS Fondazione Policlinico San Matteo Pavia Italy

Genmab US Inc Plainsboro NJ USA

Hematology Department Institut Català d'Oncologia Hospitalet IDIBELL University of Barcelona Barcelona Spain

Hematology Department University Hospital Hôtel Dieu Nantes France

Hospital Clínic de Barcelona IDIBAPS Barcelona Spain

Hospital Clínic de Barcelona Institut d'Investigacions Biomèdiques August Pi i Sunyer Barcelona Spain

Institute of Haematology Royal Prince Alfred Hospital and University of Sydney Camperdown NSW Australia

IRCCS Azienda Ospedaliero Universitaria di Bologna Istituto di Ematologia Seràgnoli Dipartimento di Medicina Specialistica Diagnostica e Sperimentale Università di Bologna Bologna Italy

Janssen Research and Development Beerse Belgium

Janssen Research and Development LLC Beijing China

Janssen Research and Development LLC Leiden The Netherlands

Janssen Research and Development LLC Spring House PA USA

Malignant Haematology and Stem Cell Transplantation Service Alfred Health Monash University Melbourne Australia

Myeloma Unit Division of Hematology University of Torino Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino Torino Italy

National and Kapodistrian University of Athens Athens Greece

Oslo Myeloma Center Department of Hematology Oslo University Hospital Oslo Norway and KG Jebsen Center for B cell Malignancies University of Oslo Oslo Norway

Plasma Cell Dyscrasias Center Department of Hematology Jagiellonian University Medical College Kraków Poland

University Medical Center Groningen Groningen The Netherlands

University of Leuven Leuven Belgium

University of Melbourne and St Vincent's Hospital Melbourne Australia

University of Poitiers CHU and Inserm 1313 Poitiers France

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ClinicalTrials.gov
NCT02874742