dc.contributor.author | Usmani, SZ | |
dc.contributor.author | Nahi, H | |
dc.contributor.author | Legiec, W | |
dc.contributor.author | Grosicki, S | |
dc.contributor.author | Vorobyev, V | |
dc.contributor.author | Spicka, I | |
dc.contributor.author | Hungria, V | |
dc.contributor.author | Korenkova, S | |
dc.contributor.author | Bahlis, NJ | |
dc.contributor.author | Flogegard, M | |
dc.contributor.author | Bladé, J | |
dc.contributor.author | Moreau, P | |
dc.contributor.author | Kaiser, M | |
dc.contributor.author | Iida, S | |
dc.contributor.author | Laubach, J | |
dc.contributor.author | Magen, H | |
dc.contributor.author | Cavo, M | |
dc.contributor.author | Hulin, C | |
dc.contributor.author | White, D | |
dc.contributor.author | De Stefano, V | |
dc.contributor.author | Lantz, K | |
dc.contributor.author | O'Rourke, L | |
dc.contributor.author | Heuck, C | |
dc.contributor.author | Delioukina, M | |
dc.contributor.author | Qin, X | |
dc.contributor.author | Nnane, I | |
dc.contributor.author | Qi, M | |
dc.contributor.author | Mateos, M-V | |
dc.coverage.spatial | Italy | |
dc.date.accessioned | 2022-06-15T13:31:21Z | |
dc.date.available | 2022-06-15T13:31:21Z | |
dc.date.issued | 2022-10-01 | |
dc.identifier.citation | Haematologica: the hematology journal, 2022, | |
dc.identifier.issn | 0390-6078 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5181 | |
dc.identifier.eissn | 1592-8721 | |
dc.identifier.eissn | 1592-8721 | |
dc.identifier.doi | 10.3324/haematol.2021.279459 | |
dc.description.abstract | 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. | |
dc.format | Print-Electronic | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | FERRATA STORTI FOUNDATION | |
dc.relation.ispartof | Haematologica: the hematology journal | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | |
dc.title | Final analysis of the phase III non-inferiority COLUMBA study of subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2022-03-23 | |
dc.date.updated | 2022-06-15T13:28:25Z | |
rioxxterms.version | AM | |
rioxxterms.versionofrecord | 10.3324/haematol.2021.279459 | |
rioxxterms.licenseref.startdate | 2022-03-31 | |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/35354247 | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Genetics and Epidemiology | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Genetics and Epidemiology/Myeloma Molecular Therapy | |
pubs.publication-status | Published online | |
icr.researchteam | Myeloma Molecular Therapy | |
dc.contributor.icrauthor | Kaiser, Martin | |