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Subcutaneous daratumumab plus standard treatment regimens in patients with multiple myeloma across lines of therapy (PLEIADES): an open-label Phase II study.

Chari, A., Rodriguez-Otero, P., McCarthy, H., Suzuki, K., Hungria, V., Sureda Balari, A., Perrot, A., Hulin, C., Magen, H., Iida, S., Maisnar, V., Karlin, L., Pour, L., Parasrampuria, D.A., Masterson, T., Kosh, M., Yang, S., Delioukina, M., Qin, M., Carson, R. and Touzeau, C., 2021. Subcutaneous daratumumab plus standard treatment regimens in patients with multiple myeloma across lines of therapy (PLEIADES): an open-label Phase II study. British Journal of Haematology, 192 (5), 869-878.

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DOI: 10.1111/bjh.16980

Abstract

© 2020 The Authors. 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.

Item Type:Article
ISSN:0007-1048
Additional Information:Research Funding Janssen Research and Development, LLC Janssen Global Services, LLC
Uncontrolled Keywords:subcutaneous, daratumumab, NDMM, RRMM, combination therapy.
Group:Faculty of Health & Social Sciences
ID Code:34864
Deposited By: Unnamed user with email symplectic@symplectic
Deposited On:23 Nov 2020 13:07
Last Modified:27 May 2021 07:55

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