Article detail · 2018
Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma
- Year
- 2018
- Type
- article
Data source split
- YÖKSİS YÖKSİS article record
- YÖKSİS venue New England Journal of Medicine
- Catalog match (ISSN) New England Journal of Medicine
- OpenAlex OpenAlex enrichment (abstract, citations, topics)
Abstract
OpenAlex · English
BACKGROUND: The combination of bortezomib, melphalan, and prednisone is a standard treatment for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplantation. Daratumumab has shown efficacy in combination with standard-of-care regimens in patients with relapsed or refractory multiple myeloma. METHODS: In this phase 3 trial, we randomly assigned 706 patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation to receive nine cycles of bortezomib, melphalan, and prednisone either alone (control group) or with daratumumab (daratumumab group) until disease progression. The primary end point was progression-free survival. RESULTS: white cells), as compared with 6.2% of those in the control group (P<0.001). The most common adverse events of grade 3 or 4 were hematologic: neutropenia (in 39.9% of the patients in the daratumumab group and in 38.7% of those in the control group), thrombocytopenia (in 34.4% and 37.6%, respectively), and anemia (in 15.9% and 19.8%, respectively). The rate of grade 3 or 4 infections was 23.1% in the daratumumab group and 14.7% in the control group; the rate of treatment discontinuation due to infections was 0.9% and 1.4%, respectively. Daratumumab-associated infusion-related reactions occurred in 27.7% of the patients. CONCLUSIONS: Among patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation, daratumumab combined with bortezomib, melphalan, and prednisone resulted in a lower risk of disease progression or death than the same regimen without daratumumab. The daratumumab-containing regimen was associated with more grade 3 or 4 infections. (Funded by Janssen Research and Development; ALCYONE ClinicalTrials.gov number, NCT02195479 .).
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999 citations
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6 publications in the local catalog that cite this work (OpenAlex reference match; not the full global list).
- Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma 2024
- Treatment of Patients with Newly-Diagnosed Multiple Myeloma 2022
- Contemporary patient-tailored treatment strategies against high risk and relapsed or refractory multiple myeloma 2019
- VAD Chemotherapy Versus Bortezomib Containing Regimens As Remission Induction For ASCT in Multiple Myeloma: A Single Center Experience 2020
- VAD Chemotherapy Versus Bortezomib Containing Regimens As Remission Induction For ASCT in Multiple Myeloma: A Single Center Experience 2020
- 2026 Myeloma Treatment Guidelines of the Turkish Myeloma Study Group 2026