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http://hdl.handle.net/2445/174026
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DC Field | Value | Language |
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dc.contributor.author | Chari, Ajai | - |
dc.contributor.author | Rodríguez Otero, Paula | - |
dc.contributor.author | McCarthy, Helen | - |
dc.contributor.author | Suzuki, Kenshi | - |
dc.contributor.author | Hungria, Vania | - |
dc.contributor.author | Sureda, Anna | - |
dc.contributor.author | Perrot, Aurore | - |
dc.contributor.author | Hulin, Cyrille | - |
dc.contributor.author | Magen, Hila | - |
dc.contributor.author | Iida, Shinsuke | - |
dc.contributor.author | Maisnar, Vladimir | - |
dc.contributor.author | Karlin, Lionel | - |
dc.contributor.author | Pour, Ludek | - |
dc.contributor.author | Parasrampuria, Dolly A. | - |
dc.contributor.author | Masterson, Tara | - |
dc.contributor.author | Kosh, Michele | - |
dc.contributor.author | Yang, Shiyi | - |
dc.contributor.author | Delioukina, Maria | - |
dc.contributor.author | Qi, Ming | - |
dc.contributor.author | Carson, Robin | - |
dc.contributor.author | Touzeau, Cyrille | - |
dc.date.accessioned | 2021-02-18T18:25:56Z | - |
dc.date.available | 2021-02-18T18:25:56Z | - |
dc.date.issued | 2020-07-30 | - |
dc.identifier.uri | http://hdl.handle.net/2445/174026 | - |
dc.description.abstract | Daratumumab is a CD38-targeting monoclonal antibody approved for intravenous (IV) infusion for multiple myeloma (MM). We describe the Phase II PLEIADES study of a subcutaneous formulation of daratumumab (DARA SC) in combination with standard-of-care regimens: DARA SC plus bortezomib/lenalidomide/dexamethasone (D-VRd) for transplant-eligible newly diagnosed MM (NDMM); DARA SC plus bortezomib/melphalan/prednisone (D-VMP) for transplant-ineligible NDMM; and DARA SC plus lenalidomide/dexamethasone (D-Rd) for relapsed/refractory MM. In total, 199 patients were treated (D-VRd, n = 67; D-VMP, n = 67; D-Rd, n = 65). The primary endpoints were met for all cohorts: the ≥very good partial response (VGPR) rate after four 21-day induction cycles for D-VRd was 71·6% [90% confidence interval (CI) 61·2-80·6%], and the overall response rates (ORRs) for D-VMP and D-Rd were 88·1% (90% CI 79·5-93·9%) and 90·8% (90% CI 82·6-95·9%). With longer median follow-up for D-VMP and D-Rd (14·3 and 14·7 months respectively), responses deepened (ORR: 89·6%, 93·8%; ≥VGPR: 77·6%, 78·5%), and minimal residual disease-negativity (10-5 ) rates were 16·4% and 15·4%. Infusion-related reactions across all cohorts were infrequent (≤9·0%) and mild. The median DARA SC administration time was 5 min. DARA SC with standard-of-care regimens demonstrated comparable clinical activity to DARA IV-containing regimens, with low infusion-related reaction rates and reduced administration time. | - |
dc.format.extent | 10 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Wiley | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1111/bjh.16980 | - |
dc.relation.ispartof | British Journal of Haematology, 2020, vol. 192, num. 5, p. 869-878 | - |
dc.relation.uri | https://doi.org/10.1111/bjh.16980 | - |
dc.rights | cc by (c) Chari et al., 2020 | - |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/3.0/es/ | - |
dc.source | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) | - |
dc.subject.classification | Anticossos monoclonals | - |
dc.subject.classification | Mieloma múltiple | - |
dc.subject.other | Monoclonal antibodies | - |
dc.subject.other | Multiple myeloma | - |
dc.title | Subcutaneous daratumumab plus standard treatment regimens in patients with multiple myeloma across lines of therapy (PLEIADES): an open‐label Phase II study | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.date.updated | 2021-02-15T14:03:29Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 33216361 | - |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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