Daratumumab for the Treatment of Multiple Myeloma: A Review of Clinical Applicability and Operational Considerations

1. National Cancer Institute . Cancer stat facts: myeloma. Accessed March 8, 2021. https://seer.cancer.gov/statfacts/html/mulmy.html.
Google Scholar2. Ackley, J, Armenta Ochoa, M, Ghoshal, D, et al. Keeping myeloma in check: the past, present and future of immunotherapy in multiple myeloma. Cancers (Basel). 2021;13(19):4787. doi:10.3390/cancers13194787.
Google Scholar | Crossref | Medline3. Lu, RM, Hwang, YC, Liu, IJ, et al. Development of therapeutic antibodies for the treatment of diseases. J Biomed Sci. 2020;27(1):1. doi:10.1186/s12929-019-0592-z.
Google Scholar | Crossref | Medline4. Darzalex (daratumumab) . Horsham, PA: Janssen Biotech, Inc; 2021.
Google Scholar5. Hogan, KA, Chini, CCS, Chini, EN. The multi-faceted ecto-enzyme CD38: roles in immunomodulation, cancer, aging, and metabolic diseases. Front Immunol. 2019;10:1187. doi:10.3389/fimmu.2019.01187.
Google Scholar | Crossref | Medline6. Overdijk, MB, Verploegen, S, Bogels, M, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. Mabs. 2015;7(2):311-321. doi:10.1080/19420862.2015.1007813.
Google Scholar | Crossref | Medline7. Overdijk, MB, Jansen, JH, Nederend, M, et al. The therapeutic CD38 monoclonal antibody daratumumab induces programmed cell death via fcγ receptor-mediated cross-linking. J Immunol. 2016;197(3):807-813. doi:10.4049/jimmunol.1501351.
Google Scholar | Crossref | Medline8. Krejcik, J, Casneuf, T, Nijhof, IS, et al. Daratumumab depletes CD38+ immune regulatory cells, promotes T-cell expansion, and skews T-cell repertoire in multiple myeloma. Blood. 2016;128(3):384-394. doi:10.1182/blood-2015-12-687749.
Google Scholar | Crossref | Medline9. van de Donk, NWCJ . Reprint of “Immunomodulatory effects of CD38-targeting antibodies.” Immunol Lett. 2019;205:71-77. doi:10.1016/j.imlet.2019.02.002.
Google Scholar | Crossref | Medline10. Lokhorst, HM, Plesner, T, Laubach, JP, et al. Targeting CD38 with daratumumab monotherapy in multiple myeloma. N Engl J Med. 2015;373:1207-1219. doi:10.1056/NEJMoa1506348.
Google Scholar | Crossref | Medline | ISI11. Lonial, S, Weiss, BM, Usmani, SZ, et al. Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial. Lancet. 2016;387(10027):1551-1560. doi:10.1016/S0140-6736(15)01120-4
Google Scholar | Crossref | Medline | ISI12. Palumbo, A, Chanan-Khan, A, Weisel, K, et al. Daratumumab, bortezomib, and dexamethasone for multiple myeloma. N Engl J Med. 2016;375:754-766. doi:10.1056/NEJMoa1606038.
Google Scholar | Crossref | Medline | ISI13. Dimopoulos, MA, Oriol, A, Nahi, H, et al. Daratumumab, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;375(14):1319-1331. doi:10.1056/NEJMoa1607751.
Google Scholar | Crossref | Medline | ISI14. Dimopoulos, MA, Terpos, E, Boccadoro, M, et al. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021;22(6):801-812. doi:10.1016/S1470-2045(21)00128-5.
Google Scholar | Crossref | Medline15. Dimopoulos, M, Quach, H, Mateos, MV, et al. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): results from a randomised, multicentre, open-label, phase 3 study. Lancet. 2020;396:186-197. doi:10.1016/S0140-6736(20)30734-0.
Google Scholar | Crossref | Medline16. Usmani, SZ, Nahi, H, Mateos, M-V, et al. Subcutaneous delivery of daratumumab in relapsed or refractory multiple myeloma. Blood. 2019;134(8):668-677. doi:10.1182/blood.2019000667.
Google Scholar | Crossref | Medline17. San-Miguel, J, Usmani, SZ, Mateos, M-V, et al. Subcutaneous daratumumab in patients with relapsed or refractory multiple myeloma: part 2 of the open-label, multicenter, dose-escalation phase 1b study (PAVO). Haematologica. 2021;106(6):1725-1732. doi:10.3324/haematol.2019.243790.
Google Scholar | Crossref | Medline18. Chari, A, Rodriguez-Otero, P, McCarthy, H, et al. Subcutaneous daratumumab plus standard treatment regimens in patients with multiple myeloma across lines of therapy (PLEIADES): an open-label phase II study. Br J Haematol. 2021;192(5):869-878. doi:10.1111/bjh.16980.
Google Scholar | Crossref | Medline19. Mateos, M-V, Nahi, H, Legiec, W, et al. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. Lancet Haematol. 2020;7(5):e370-e380. doi:10.1016/S2352-3026(20)30070-3.
Google Scholar | Crossref | Medline20. Mateos, MV, Dimopoulos, MA, Cavo, M, et al. Daratumumab plus bortezomib, melphalan, and prednisone for untreated myeloma. N Engl J Med. 2018;378(6):518-528. doi:10.1056/NEJMoa1714678.
Google Scholar | Crossref | Medline21. Facon, T, Kumar, S, Plesner, T, et al. Daratumumab plus lenalidomide and dexamethasone for untreated myeloma. N Engl J Med. 2019;380(22):2104-2115. doi:10.1056/NEJMoa1817249.
Google Scholar | Crossref | Medline22. Moreau, P, Attal, M, Hulin, C, et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study. Lancet. 2019;394(10192):29-38. doi:10.1016/S0140-6736(19)31240.
Google Scholar | Crossref | Medline23. Voorhees, PM, Kaufman, JL, Laubach, JP, et al. Daratumumab, lenalidomide, bortezomib, & dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial. Blood. 2020;136:936-945. doi:10.1182/blood.2020005288.
Google Scholar | Crossref | Medline24. Attal, M, Richardson, PG, Rajkumar, SV, et al. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019;394:2096-2107. doi:10.1016/S0140-6736(19)32556-5.
Google Scholar | Crossref | Medline25. Moreau, P, Dimopoulos, MA, Mikhael, J, et al. Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial. Lancet. 2021;397(10292):2361-2371. doi:10.1016/S0140-6736(21)00592-4.
Google Scholar | Crossref | Medline26. Garcia-Guerrero, E, Gogishvili, T, Danhof, S, et al. Panobinostat induces CD38 upregulation and augments the antimyeloma efficacy of daratumumab. Blood. 2017;129(25):3386-3388. doi:10.1182/blood-2017-03-770776.
Google Scholar | Crossref | Medline27. Mikhael, J, Ismaila, N, Cheung, MC, et al. Treatment of multiple myeloma: ASCO and CCO joint clinical practice guideline. J Clin Oncol. 2019;37(14):1228-1263. doi:10.1200/JCO.18.02096.
Google Scholar | Crossref | Medline28. Benboubker, L, Dimopoulos, MA, Dispenzieri, A, et al. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. N Engl J Med. 2014;37(10):906-917. doi:10.1056/NEJMoa1402551.
Google Scholar | Crossref29. Palumbo, A, Rajkumar, SV, San Miguel, JF, et al. International Myeloma Working Group consensus statement for the management, treatment, and supportive care of patients with myeloma not eligible for standard autologous stem-cell transplantation. J Clin Oncol. 2014;32(6):587-600. doi:10.1200/JCO.2013.48.7934.
Google Scholar | Crossref | Medline30. Cao, Y, Wan, N, Liang, Z, et al. Treatment outcomes in patients with newly diagnosed multiple myeloma who are ineligible for stem-cell transplantation: systematic review and network meta-analysis. Clin Lymphoma Myeloma Leuk. 2019;19(8):e478-e488. doi:10.1016/j.clml.2019.04.009.
Google Scholar | Crossref | Medline31. O’Donnell, EK, Laubach, JP, Yee, AJ, et al. A phase 2 study of modified lenalidomide, bortezomib and dexamethasone in transplant-ineligible multiple myeloma. Br J Haematol. 2018;182(2):222-230. doi:10.1111/bjh.15261.
Google Scholar | Crossref | Medline32. Mateos, MV, Cavo, M, Blade, J, et al. Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial. Lancet. 2020;395(10218):132-141. doi:10.1016/S0140-6736(19)32956-3.
Google Scholar | Crossref | Medline33. Facon, T, Kumar, S, Plesner, T, et al. Overall survival results with daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone in transplant-ineligible newly diagnosed multiple myeloma: phase 3 MAIA study. Paper presented at 2021 European Hematology Association Virtual Congress; ; Vienna, Austria.
Google Scholar34. Moreau, P, Hulin, C, Perrot, A, et al. Maintenance with daratumumab or observation following treatment with bortezomib, thalidomide, and dexamethasone with or without daratumumab and autologous stem-cell transplant in patients with newly diagnosed multiple myeloma (CASSIOPEIA): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021;22(10):1378-1390. doi:10.1016/S1470-2045(21)00428-9.
Google Scholar | Crossref | Medline35. National Comprehensive Cancer Network clinical practice guidelines in oncology (NCCN guidelines) . Multiple myeloma, version 7; 2021. Accessed June 30, 2021. https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf.
Google Scholar36. Darzalex Faspro (daratumumab/hyaluronidase-fihj) . Horsham, PA: Janssen Biotech, Inc; 2021.
Google Scholar37. Sarclisa (isatuximab) . Bridgewater, NJ: Sanofi-aventis U.S. LLC; 2020.
Google Scholar38. UpToDate . Daratumumab: Drug Information. Waltham, MA: Wolters Kluwer Health; 2021.
Google Scholar39. UpToDate . Isatuximab: Drug Information. Waltham, MA: Wolters Kluwer Health; 2021.
Google Scholar40. Han, X, Jorgensen, JL, Brahmandam, A, et al. Immunophenotypic study of basophils by multiparameter flow cytometry. Arch Pathol Lab Med. 2008;132(5):813-819. doi:10.5858/2008-132-813-ISOBBM.
Google Scholar | Crossref | Medline41. Chari, A, Lonial, S, Mark, TM, et al. Results of an early access treatment protocol of daratumumab in United States patients with relapsed or refractory multiple myeloma. Cancer. 2018;124(22):4342-4349. doi:10.1002/cncr.31706.
Google Scholar | Crossref | Medline42. Moore, DC, Arnall, JR, Thompson, DL, et al. Evaluation of montelukast for the prevention of infusion-related reactions with daratumumab. Clin Lymphoma Myeloma Leuk. 2020;20(10):e777-e781. doi:10.1016/j.clml.2020.05.024.
Google Scholar | Crossref | Medline43. Hamadeh, IS, Moore, DC, Martin, A, et al. Transition from intravenous to subcutaneous daratumumab formulation in clinical practice. Clin Lymphoma Myeloma Leuk. 2021;21(7):470-475. doi:10.1016/j.clml.2021.02.014.
Google Scholar | Crossref | Medline44. Xu, S, Moreau, P, Usmani, SZ, et al. Split first dose administration of intravenous daratumumab for the treatment of multiple myeloma (MM): clinical and population pharmacokinetic analyses. Adv Ther. 2020;37(4):1464-1478. doi:10.1007/s12325-020-01247-8.
Google Scholar | Crossref | Medline45. Chari, A, Martinez-Lopez, J, Mateos, MV, et al. Daratumumab plus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma. Blood. 2019;134(5):421-431. doi:10.1182/blood.2019000722.
Google Scholar | Crossref | Medline46. Arnall, JR, Moore, DC, Hill, HL, et al. Enhancing the feasibility of outpatient daratumumab administration via a split-dosing strategy with initial doses. Leuk Lym

留言 (0)

沒有登入
gif