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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.
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It is part of: British Journal of Haematology, 2020, vol. 192, num. 5, p. 869-878
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Appears in Collections:Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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