Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial

The Lancet Haematology - Tập 7 Số 5 - Trang e370-e380 - 2020
María‐Victoria Mateos1,2, Hareth Nahi3, Wojciech Legieć4, Sebastian Grosicki5, Vladimir Vorobyev6, Ivan Špıčka7,8, Vânia Hungria9, Sibirina Korenkova10, Nizar J. Bahlis11, Max Flogegård12, Joan Bladé13, Philippe Moreau14, Martin Kaiser15,16, Shinsuke Iida17, Jacob P. Laubach18, Hila Magen19, Michèle Cavo20, Cyrille Hulin21, Darrell White22, Valerio De Stefano23,24, Pamela L. Clemens25, Tara Masterson25, Kristen Lantz25, Lisa O’Rourke25, Christoph Heuck25, Xiang Qin26, Dolly A. Parasrampuria25, Zhilong Yuan26, Xu Steven Xu27,25, Ming Qi25, Saad Z. Usmani28
1Cancer Research Unit, University Hospital of Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), Salamanca, Spain
2Institute of Cancer Molecular and Cellular Biology (USAL-CSIC), Centre for Cancer Research (IBMCC), Instituto de Investigación Biomédica de Salamanca (IBSAL), Salamanca, Spain
3Unit of Hematology, Department of Medicine, Karolinska University Hospital at Huddinge, Karolinska Institutet, Stockholm, Sweden
4Department of Hemato-Oncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland
5Department of Hematology and Cancer Prevention, School of Public Health in Bytom, Medical University of Silesia in Katowice, Katowice, Poland
6S. P. Botkin City Clinical Hospital, Moscow, Russia
71st Department of Medicine, Department of Hematology, First Faculty of Medicine, Charles University, Prague, Czech Republic
8General University Hospital in Prague, Charles University, Prague, Czech Republic
9Clinica São Germano, São Paulo, Brazil
10Kiev Bone Marrow Transplantation Center, Kiev, Ukraine
11Arnie Charbonneau Cancer Institute, University of Calgary, Calgary, AB, Canada;
12Department of Internal Medicine, Falun General Hospital, Falun, Sweden
13Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain
14University Hospital of Nantes, Nantes, France
15Department of Haemato-oncology, Royal Marsden Hospital, London, UK
16Division of Molecular Pathology Institute of Cancer Research, London, UK
17Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
18Department of Hematology and Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA
19Department of Hematology Chaim Sheba Medical Center, Ramat-Gan, Sackler Faculty of Medicine, Tel Aviv, Israel
20Diagnostic and Specialty Medicine Department, Seràgnoli Institute of Hematology, University of Bologna, Bologna, Italy
21Centre Hospitalier Universitaire Bordeaux, Pessac, France;
22Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NS, Canada
23Fondazione Policlinico Universitario Agostino Gemelli, Istituto di Ricovero e Cura a Carattere Scientifico, Università Cattolica del Sacro Cuore, Rome, Italy
24Institute of Hematology, Università Cattolica del Sacro Cuore, Rome, Italy
25Janssen Research & Development, Spring House, PA, USA
26Janssen Research & Development, Raritan, NJ, USA
27Genmab US, Princeton, NJ, USA
28Levine Cancer Institute, Atrium Health, Charlotte, NC, USA

Tóm tắt

Từ khóa


Tài liệu tham khảo

Lokhorst, 2015, Targeting CD38 with daratumumab monotherapy in multiple myeloma, N Engl J Med, 373, 1207, 10.1056/NEJMoa1506348

Usmani, 2016, Clinical efficacy of daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma, Blood, 128, 37, 10.1182/blood-2016-03-705210

Lonial, 2016, Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial, Lancet, 387, 1551, 10.1016/S0140-6736(15)01120-4

Dimopoulos, 2016, Daratumumab, lenalidomide, and dexamethasone for multiple myeloma, N Engl J Med, 375, 1319, 10.1056/NEJMoa1607751

Palumbo, 2016, Daratumumab, bortezomib, and dexamethasone for multiple myeloma, N Engl J Med, 375, 754, 10.1056/NEJMoa1606038

Mateos, 2018, Daratumumab plus bortezomib, melphalan, and prednisone for untreated myeloma, N Engl J Med, 378, 518, 10.1056/NEJMoa1714678

Facon, 2019, Daratumumab plus lenalidomide and dexamethasone for untreated myeloma, N Engl J Med, 380, 2104, 10.1056/NEJMoa1817249

Moreau, 2019, Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study, Lancet, 394, 29, 10.1016/S0140-6736(19)31240-1

Bittner, 2018, Subcutaneous administration of biotherapeutics: an overview of current challenges and opportunities, BioDrugs, 32, 425, 10.1007/s40259-018-0295-0

Usmani, 2019, Subcutaneous delivery of daratumumab in relapsed or refractory multiple myeloma, Blood, 134, 668, 10.1182/blood.2019000667

Clemens, 2018, Pharmacokinetics (PK) of subcutaneous daratumumab in patients with relapsed or refractory (RR) multiple myeloma (MM): primary clinical pharmacology analysis of the open-label, multicenter, phase 1b study (PAVO), Blood, 132, 10.1182/blood-2018-99-113161

Chari, 2018, Subcutaneous daratumumab (DARA) in patients (Pts) with relapsed or refractory multiple myeloma (RRMM): part 2 update of the open-label, multicenter, dose escalation phase 1b study (PAVO), Proc Am Soc Clin Oncol, 36

Rajkumar, 2011, Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1, Blood, 117, 4691, 10.1182/blood-2010-10-299487

Abetz, 2005, Development of the cancer therapy satisfaction questionnaire: item generation and content validity testing, Value Health, 8, S41, 10.1111/j.1524-4733.2005.00073.x

Trask, 2008, Psychometric validation of the cancer therapy satisfaction questionnaire, Value Health, 11, 669, 10.1111/j.1524-4733.2007.00310.x

Harousseau, 2009, Achievement of at least very good partial response is a simple and robust prognostic factor in patients with multiple myeloma treated with high-dose therapy: long-term analysis of the IFM 99–02 and 99–04 Trials, J Clin Oncol, 27, 5720, 10.1200/JCO.2008.21.1060

Kapoor, 2013, Importance of achieving stringent complete response after autologous stem-cell transplantation in multiple myeloma, J Clin Oncol, 31, 4529, 10.1200/JCO.2013.49.0086

Xu, 2017, Clinical implications of complex pharmacokinetics for daratumumab dose regimen in patients with relapsed/refractory multiple myeloma, Clin Pharmacol Ther, 101, 721, 10.1002/cpt.577

Zhao, 2013, The antibody drug absorption following subcutaneous or intramuscular administration and its mathematical description by coupling physiologically based absorption process with the conventional compartment pharmacokinetic model, J Clin Pharmacol, 53, 314, 10.1002/jcph.4

Bai, 2012, A guide to rational dosing of monoclonal antibodies, Clin Pharmacokinet, 51, 119, 10.2165/11596370-000000000-00000

Anderson, 2019, Humanistic and economic impact of subcutaneous versus intravenous administration of oncology biologics, Future Oncol, 15, 3267, 10.2217/fon-2019-0368

Hendrikx, 2017, Fixed dosing of monoclonal antibodies in oncology, Oncologist, 22, 1212, 10.1634/theoncologist.2017-0167

Thông tin
Thông tin xuất bản

The Lancet Haematology

Tập 7 Số 5

e370-e380

Thông tin tác giả