Please use this identifier to cite or link to this item:
http://hdl.handle.net/2445/174026
Title: | Subcutaneous daratumumab plus standard treatment regimens in patients with multiple myeloma across lines of therapy (PLEIADES): an open‐label Phase II study |
Author: | Chari, Ajai Rodríguez Otero, Paula McCarthy, Helen Suzuki, Kenshi Hungria, Vania Sureda, Anna Perrot, Aurore Hulin, Cyrille Magen, Hila Iida, Shinsuke Maisnar, Vladimir Karlin, Lionel Pour, Ludek Parasrampuria, Dolly A. Masterson, Tara Kosh, Michele Yang, Shiyi Delioukina, Maria Qi, Ming Carson, Robin Touzeau, Cyrille |
Keywords: | Anticossos monoclonals Mieloma múltiple Monoclonal antibodies Multiple myeloma |
Issue Date: | 30-Jul-2020 |
Publisher: | Wiley |
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. |
Note: | Reproducció del document publicat a: https://doi.org/10.1111/bjh.16980 |
It is part of: | British Journal of Haematology, 2020, vol. 192, num. 5, p. 869-878 |
URI: | http://hdl.handle.net/2445/174026 |
Related resource: | https://doi.org/10.1111/bjh.16980 |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
bjh.16980.pdf | 328.21 kB | Adobe PDF | View/Open |
This item is licensed under a
Creative Commons License