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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.
Subcutaneous daratumumab plus standard treatment regimens in patients with multiple myeloma across lines of therapy (PLEIADES): an open-label Phase II study.
- Source :
-
British journal of haematology [Br J Haematol] 2021 Mar; Vol. 192 (5), pp. 869-878. Date of Electronic Publication: 2020 Jul 30. - Publication Year :
- 2021
-
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 <superscript>-5</superscript> ) 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.<br /> (© 2020 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.)
- Subjects :
- Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal administration & dosage
Antibodies, Monoclonal adverse effects
Antineoplastic Agents, Immunological administration & dosage
Antineoplastic Agents, Immunological adverse effects
Bortezomib administration & dosage
Combined Modality Therapy
Dexamethasone administration & dosage
Female
Follow-Up Studies
Hematologic Diseases chemically induced
Humans
Lenalidomide administration & dosage
Male
Melphalan administration & dosage
Middle Aged
Prednisone administration & dosage
Standard of Care
Treatment Outcome
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Immunotherapy
Multiple Myeloma drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1365-2141
- Volume :
- 192
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- British journal of haematology
- Publication Type :
- Academic Journal
- Accession number :
- 33216361
- Full Text :
- https://doi.org/10.1111/bjh.16980