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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
- Source :
- Dipòsit Digital de la UB, Universidad de Barcelona
- Publication Year :
- 2020
-
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 center dot 6% [90% confidence interval (CI) 61 center dot 2-80 center dot 6%], and the overall response rates (ORRs) for D-VMP and D-Rd were 88 center dot 1% (90% CI 79 center dot 5-93 center dot 9%) and 90 center dot 8% (90% CI 82 center dot 6-95 center dot 9%). With longer median follow-up for D-VMP and D-Rd (14 center dot 3 and 14 center dot 7 months respectively), responses deepened (ORR: 89 center dot 6%, 93 center dot 8%; >= VGPR: 77 center dot 6%, 78 center dot 5%), and minimal residual disease-negativity (10(-5)) rates were 16 center dot 4% and 15 center dot 4%. Infusion-related reactions across all cohorts were infrequent (
- Subjects :
- Melphalan
Adult
Male
Phases of clinical research
Dexamethasone
DOT 5
Bortezomib
03 medical and health sciences
DOT 4
0302 clinical medicine
DOT 3
Antineoplastic Agents, Immunological
Multiple myeloma
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Lenalidomide
Aged
Aged, 80 and over
business.industry
Mieloma mĂșltiple
Daratumumab
Antibodies, Monoclonal
Standard of Care
Hematology
Middle Aged
medicine.disease
Combined Modality Therapy
Hematologic Diseases
Treatment Outcome
030220 oncology & carcinogenesis
Prednisone
Monoclonal antibodies
Female
Immunotherapy
Nuclear medicine
business
Multiple Myeloma
Anticossos monoclonals
030215 immunology
medicine.drug
Follow-Up Studies
Subjects
Details
- ISSN :
- 13652141 and 00071048
- Volume :
- 192
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- British journal of haematologyReferences
- Accession number :
- edsair.doi.dedup.....a34a7c70db01d1bec4e66a3ec39697d5