The DOI matches its Crossref record; 27 of the 27 references it cites were found in a registry or an index.
Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma
Open accessAbstract
BACKGROUNDThe 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. METHODSIn 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. RESULTSAt a median follow-up of 16.5 months in a prespecified interim analysis, the 18-month progression-free survival rate was 71.6% (95% confidence interval [CI], 65.5 to 76.8) in the daratumumab group and 50.2% (95% CI, 43.2 to 56.7) in the control group (hazard ratio for disease progression or death, 0.50; 95% CI, 0.38 to 0.65; P<0.001).The overall response rate was 90.9% in the daratumumab group, as compared with 73.9% in the control group (P<0.001), and the rate of complete response or better (including stringent complete response) was 42.6%, versus 24.4% (P<0.001).In the daratumumab group, 22.3% of the patients were negative for minimal residual disease (at a threshold of 1 tumor cell per 10 5 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.Daratumumabassociated infusion-related reactions occurred in 27.7% of the patients. CONCLUSIONSAmong patients with newly diagnosed multiple myeloma who were ineligible for stemcell 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.govnumber, NCT02195479.
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Citations
Cites
International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma
Rajkumar, S. V., Dimopoulos, M. A., Palumbo, A., Blade, J., Merlini, G., Mateos, M.-V., Kumar, S., Hillengass, J., Kastritis, E., Richardson, P., et al. (2014) · The Lancet Oncology · doi:10.1016/s1470-2045(14)70442-5 · Cited by 4,978
Self-citationKumar, S., Paiva, B., Anderson, K. C., Durie, B., Landgren, O., Moreau, P., Munshi, N., Lonial, S., Bladé, J., Mateos, M.-V., et al. (2016) · The Lancet Oncology · doi:10.1016/s1470-2045(16)30206-6 · Cited by 3,061
Self-citationInternational uniform response criteria for multiple myeloma
Durie, B. G. M., Harousseau, J.-L., Miguel, J. S., Bladé, J., Barlogie, B., Anderson, K., Gertz, M., Dimopoulos, M., Westin, J., Sonneveld, P., et al. (2006) · Leukemia · doi:10.1038/sj.leu.2404284 · Cited by 2,632
Self-citationPalumbo, A., Avet-Loiseau, H., Oliva, S., Lokhorst, H. M., Goldschmidt, H., Rosinol, L., Richardson, P., Caltagirone, S., Lahuerta, J. J., Facon, T., et al. (2015) · Journal of Clinical Oncology · doi:10.1200/jco.2015.61.2267 · Cited by 2,210
Self-citationBortezomib plus Melphalan and Prednisone for Initial Treatment of Multiple Myeloma
San Miguel, J. F., Schlag, R., Khuageva, N. K., Dimopoulos, M. A., Shpilberg, O., Kropff, M., Spicka, I., Petrucci, M. T., Palumbo, A., Samoilova, O. S., et al. (2008) · New England Journal of Medicine · doi:10.1056/nejmoa0801479 · Cited by 1,899
Self-citationDaratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma
Palumbo, A., Chanan-Khan, A., Weisel, K., Nooka, A. K., Masszi, T., Beksac, M., Spicka, I., Hungria, V., Munder, M., Mateos, M. V., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1606038 · Cited by 1,522
Self-citationDaratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma.
Dimopoulos, M. A., Oriol, A., Nahi, H., San-Miguel, J., Bahlis, N. J., Usmani, S. Z., Rabin, N., Orlowski, R. Z., Komarnicki, M., Suzuki, K., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1607751 · Cited by 1,445
Self-citationLenalidomide, Bortezomib, and Dexamethasone with Transplantation for Myeloma
Attal, M., Lauwers-Cances, V., Hulin, C., Leleu, X., Caillot, D., Escoffre, M., Arnulf, B., Macro, M., Belhadj, K., Garderet, L., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1611750 · Cited by 1,257
de Weers, M., Tai, Y.-T., van der Veer, M. S., Bakker, J. M., Vink, T., Jacobs, D. C. H., Oomen, L. A., Peipp, M., Valerius, T., Slootstra, J. W., et al. (2011) · The Journal of Immunology · doi:10.4049/jimmunol.1003032 · Cited by 1,037
Rajkumar, S. V., Harousseau, J.-L., Durie, B., Anderson, K. C., Dimopoulos, M., Kyle, R., Blade, J., Richardson, P., Orlowski, R., Siegel, D., et al. (2011) · Blood · doi:10.1182/blood-2010-10-299487 · Cited by 1,036
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Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma
Facon, T., Kumar, S., Plesner, T., Orlowski, R. Z., Moreau, P., Bahlis, N., Basu, S., Nahi, H., Hulin, C., Quach, H., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1817249 · Cited by 1,045
Self-citationMultiple myeloma: EHA-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up†
Dimopoulos, M. A., Moreau, P., Terpos, E., Mateos, M. V., Zweegman, S., Cook, G., Delforge, M., Hájek, R., Schjesvold, F., Cavo, M., et al. (2021) · Annals of Oncology · doi:10.1016/j.annonc.2020.11.014 · Cited by 900
Self-citationOutcomes of patients with multiple myeloma refractory to CD38-targeted monoclonal antibody therapy.
Gandhi, U. H., Cornell, R. F., Lakshman, A., Gahvari, Z. J., McGehee, E., Jagosky, M. H., Gupta, R., Varnado, W., Fiala, M. A., Chhabra, S., et al. (2019) · Leukemia · doi:10.1038/s41375-019-0435-7 · Cited by 616
Munshi, N. C., Avet-Loiseau, H., Anderson, K. C., Neri, P., Paiva, B., Samur, M., Dimopoulos, M., Kulakova, M., Lam, A., Hashim, M., et al. (2020) · Blood Advances · doi:10.1182/bloodadvances.2020002827 · Cited by 431
Self-citationD'Agostino, M., Cairns, D. A., Lahuerta, J. J., Wester, R., Bertsch, U., Waage, A., Zamagni, E., Mateos, M.-V., Dall'Olio, D., van de Donk, N. W. C. J., et al. (2022) · Journal of Clinical Oncology · doi:10.1200/jco.21.02614 · Cited by 429
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Metadata
- Authors
- Mateos, M.-V., Dimopoulos, M. A., Cavo, M., Suzuki, K., Jakubowiak, A., Knop, S., Doyen, C., Lucio, P., Nagy, Z., Kaplan, P., Pour, L., Cook, M., Grosicki, S., Crepaldi, A., Liberati, A. M., Campbell, P., Shelekhova, T., Yoon, S.-S., Iosava, G., Fujisaki, T., Garg, M., Chiu, C., Wang, J., Carson, R., Crist, W., Deraedt, W., Nguyen, H., Qi, M., & San-Miguel, J.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2018-02-08
- Volume
- 378
- Issue
- 6
- Pages
- 518-528
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2772566228
- Cited by
- 988
- References
- 27
- FWCI
- 79.44
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Mateos, M.-V., Dimopoulos, M. A., Cavo, M., Suzuki, K., Jakubowiak, A., Knop, S., Doyen, C., Lucio, P., Nagy, Z., Kaplan, P., Pour, L., Cook, M., Grosicki, S., Crepaldi, A., Liberati, A. M., Campbell, P., Shelekhova, T., Yoon, S.-S., Iosava, G., . . . San-Miguel, J. (2018). Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1714678
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