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Final analysis of the phase III non-inferiority COLUMBA study of subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma
SZ. Usmani, H. Nahi, W. Legiec, S. Grosicki, V. Vorobyev, I. Spicka, V. Hungria, S. Korenkova, NJ. Bahlis, M. Flogegard, J. Bladé, P. Moreau, M. Kaiser, S. Iida, J. Laubach, H. Magen, M. Cavo, C. Hulin, D. White, V. De Stefano, K. Lantz, L....
Language English Country Italy
Document type Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
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- MeSH
- Dexamethasone MeSH
- Administration, Intravenous MeSH
- Humans MeSH
- Neoplasm Recurrence, Local drug therapy MeSH
- Multiple Myeloma * drug therapy MeSH
- Antibodies, Monoclonal MeSH
- Antineoplastic Combined Chemotherapy Protocols adverse effects MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
In the primary analysis of the phase III COLUMBA study, daratumumab by subcutaneous administration (DARA SC) demonstrated non-inferiority to intravenous administration (DARA IV) for relapsed or refractory multiple myeloma (RRMM). Here, we report the final analysis of efficacy and safety from COLUMBA after a median of 29.3 months follow-up (additional 21.8 months after the primary analysis). In total, 522 patients were randomized (DARA SC, n=263; DARA IV, n=259). With longer follow-up, DARA SC and DARA IV continued to show consistent efficacy and maximum trough daratumumab concentration as compared with the primary analysis. The overall response rate was 43.7% for DARA SC and 39.8% for DARA IV. The maximum mean (standard deviation [SD]) trough concentration (cycle 3, day 1 pre-dose) of serum DARA was 581 (SD, 315) μg/mL for DARA SC and 496 (SD, 231) μg/mL for DARA IV. Median progression-free survival was 5.6 months for DARA SC and 6.1 months for DARA IV; median overall survival was 28.2 months and 25.6 months, respectively. Grade 3/4 treatment-emergent adverse events occurred in 50.8% of patients in the DARA SC group and 52.7% in the DARA IV group; the most common (≥10%) were thrombocytopenia (DARA SC, 14.2%; DARA IV, 13.6%), anemia (13.8%; 15.1%), and neutropenia (13.1%; 7.8%). The safety profile remained consistent with the primary analysis after longer follow-up. In summary, DARA SC and DARA IV continue to demonstrate similar efficacy and safety, with a low rate of infusion-related reactions (12.7% vs. 34.5%, respectively) and shorter administration time (3-5 minutes vs. 3-7 hours) supporting DARA SC as a preferable therapeutic choice. (Clinicaltrials gov. Identifier: NCT03277105.
Arnie Charbonneau Cancer Research Institute University of Calgary Calgary AB
Center of Oncology of the Lublin Region St Jana z Dukli Lublin
Clinica Medica São Germano São Paulo
Dalhousie University and Queen Elizabeth 2 Health Science Centre Halifax NS
Department of Hematology and Oncology Dana Farber Cancer Institute Harvard Medical School Boston MA
Department of Hematology Hôpital Haut Lévêque Pessac
Department of Internal Medicine Falun General Hospital Falun
Hematology Department University Hospital Hôtel Dieu Nantes
Janssen Research and Development LLC Raritan NJ
Janssen Research and Development LLC Spring House PA
Kiev Center for Bone Marrow Transplantation Kiev
Memorial Sloan Kettering Cancer Center New York NY
S P Botkin City Clinical Hospital Moscow Russian Federation
University Hospital of Salamanca IBSAL Cancer Research Center IBMCC Salamanca
References provided by Crossref.org
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