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http://hdl.handle.net/2445/202060
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DC Field | Value | Language |
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dc.contributor.author | Usmani, Saad Z. | - |
dc.contributor.author | Nahi, Hareth | - |
dc.contributor.author | Legiec, Wojciech | - |
dc.contributor.author | Grosicki, Sebastian | - |
dc.contributor.author | Vorobyev, Vladimir | - |
dc.contributor.author | Spicka, Ivan | - |
dc.contributor.author | Hungria, Vania | - |
dc.contributor.author | Korenkova, Sibirina | - |
dc.contributor.author | Bahlis, Nizar J. | - |
dc.contributor.author | Flogegard, Max | - |
dc.contributor.author | Bladé, J. (Joan) | - |
dc.contributor.author | Moreau, Philippe | - |
dc.contributor.author | Kaiser, Martin | - |
dc.contributor.author | Iida, Shinsuke | - |
dc.contributor.author | Laubach, Jacob | - |
dc.contributor.author | Magen, Hila | - |
dc.contributor.author | Cavo, Michele | - |
dc.contributor.author | Hulin, Cyrille | - |
dc.contributor.author | White, Darrell | - |
dc.contributor.author | Stefano, Valerio de | - |
dc.contributor.author | Lantz, Kristen | - |
dc.contributor.author | O'Rourke, Lisa | - |
dc.contributor.author | Heuck, Christoph | - |
dc.contributor.author | Delioukina, Maria | - |
dc.contributor.author | Qin, Xiang | - |
dc.contributor.author | Nnane, Ivo | - |
dc.contributor.author | Qi, Ming | - |
dc.contributor.author | Mateos, María Victoria | - |
dc.date.accessioned | 2023-09-19T15:22:56Z | - |
dc.date.available | 2023-09-19T15:22:56Z | - |
dc.date.issued | 2022-10 | - |
dc.identifier.issn | 1592-8721 | - |
dc.identifier.uri | http://hdl.handle.net/2445/202060 | - |
dc.description.abstract | In the primary analysis of the phase III COLUMBA study, daratumumab by subcutaneous administration (DARA SC) demon-strated 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 maxi-mum mean (standard deviation [SD]) trough concentration (cycle 3, day 1 pre-dose) of serum DARA was 581 (SD, 315) mu g/mL for DARA SC and 496 (SD, 231) mu g/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. | - |
dc.format.extent | 10 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Ferrata Storti Foundation | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.3324/haematol.2021.279459 | - |
dc.relation.ispartof | Haematologica, 2022, vol. 107, num. 10, p. 2408-2417 | - |
dc.relation.uri | https://doi.org/10.3324/haematol.2021.279459 | - |
dc.rights | cc by-nc (c) Usmani, Saad Z. et al., 2022 | - |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/3.0/es/ | * |
dc.source | Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer) | - |
dc.subject.classification | Administració de medicaments | - |
dc.subject.classification | Mieloma múltiple | - |
dc.subject.classification | Anticossos monoclonals | - |
dc.subject.other | Administration of drugs | - |
dc.subject.other | Multiple myeloma | - |
dc.subject.other | Monoclonal antibodies | - |
dc.title | Final analysis of the phase 3 non-inferiority COLUMBA study of subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.date.updated | 2023-06-22T10:24:53Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.idimarina | 9302241 | - |
dc.identifier.pmid | 35354247 | - |
Appears in Collections: | Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer) |
Files in This Item:
File | Description | Size | Format | |
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Final analysis of the phase III non-inferiority COLUMBA_Haematologica.pdf | 5.53 MB | Adobe PDF | View/Open |
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