Page 230 - 2021_06-Haematologica-web

J. San-Miguel et al. 2015;7(2):311-321.
4. Overdijk MB, Jansen JH, Nederend M, et al. The therapeutic CD38 monoclonal antibody daratumumab induces programmed cell death via Fcγ receptor-mediated cross-link- ing. J Immunol. 2016;197(3):807-813.
5.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.
6. Chiu C, Casneuf T, Axel A, et al. Daratumumab in combination with lenalidomide plus dexamethasone induces clonality increase and T-cell expansion: results from a phase 3 randomized study (POLLUX). Presented at: the 58th American Society of Hematology (ASH) Annual Meeting & Exposition; December 3-6, 2016; San Diego, CA. Abstract 4531.
7. Adams HC III, Stevenaert F, Krejcik J, et al. High-parameter mass cytometry evaluation of relapsed/refractory multiple myeloma patients treated with daratumumab demon- strates immune modulation as a novel mech- anism of action. Cytometry A. 2019;95(3): 279-289.
8. DARZALEX® (daratumumab) injection, for intravenous use [package insert]. Horsham, PA: Janssen Biotech, Inc; 2019.
9. European Medicines Agency. Summary of opinion (post authorisation). DARZALEX (daratumumab). https://www.ema.europa. eu/en/documents/smop/chmp-post-authori- sation-summary-positive-opinion-darzalex- ii-11_en.pdf. Published July 2018. Accessed August 2019.
10.Jakubowiak A, Chari A, Lonial S, et al. Daratumumab (DARA) in combination with carfilzomib, lenalidomide, and dexametha- sone (KRd) in patients (pts) with newly diag- nosed multiple myeloma (MMY1001): an open-label, phase 1b study. Presented at: the Annual Meeting of the American Society of Clinical Oncology (ASCO); June 2-6, 2017; Chicago, IL. Abstract 8000.
11. Chari A, Martinez-Lopez J, Mateos MV, et al. Daratumumab in combination with carfil- zomib and dexamethasone (D-Kd) in lenalidomide-refractory patients with relapsed multiple myeloma: subgroup analy- sis of MMY1001. Presented at: the Annual Meeting of the American Society of Clinical Oncology (ASCO); June 1-5, 2018; Chicago, IL. Abstract 8002.
12. Scheid C, Munder M, Salwender H, Engelhardt M. Infusion of daratumumab in combination therapies - practical informa- tion for the outpatient area. Dtsch Med Wochenschr. 2018;143(16):1201-1206.
13. Barr H, Dempsey J, Waller A, et al. Ninety- minute daratumumab infusion is safe in mul- tiple myeloma. Leukemia. 2018;32(11):2495- 2518.
14. Halozyme Therapeutics. Mechanism of action for Hylenex recombinant (hyaluronidase human injection). www.hylenex.com/mechanism-of-action. Accessed August 2019.
15.Usmani SZ, Nahi H, Mateos MV, et al. Subcutaneous delivery of daratumumab in relapsed or refractory multiple myeloma. Blood. 2019;134(8):668-677.
16. Lokhorst HM, Plesner T, Laubach JP, et al. Targeting CD38 with daratumumab monotherapy in multiple myeloma. N Engl J Med. 2015;373(13):1207-1219.
17. Chari A, Nahi H, Mateos MV, et al.
Subcutaneous delivery of daratumumab in patients (pts) with relapsed or refractory multiple myeloma (RRMM): PAVO, an open-label, multicenter, dose escalation phase 1b study. Presented at: the 59th American Society of Hematology (ASH) Annual Meeting & Exposition; December 9- 12, 2017; Atlanta, GA. Abstract 838.
18. US Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Common termi- nology criteria for adverse events (CTCAE): Version 4.03. https://evs.nci.nih.gov/ftp1/ CTCAE/CTCAE_4.03/CTCAE_4.03_2010- 06-14_QuickReference_5x7.pdf. Accessed August 2019.
19. Durie BGM, Harousseau JL, Miguel JS, et al. International uniform response criteria for multiple myeloma. Leukemia. 2006;20(9): 1467-1473.
20. Rajkumar SV, Harousseau JL, Durie B, et al. Consensus recommendations for the uni- form reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1. Blood. 2011;117(18): 4691-4695.
21.Xu XS, Yan X, Puchalski T, et al. Clinical implications of complex pharmacokinetics for daratumumab dose regimen in patients with relapsed/refractory multiple myeloma. Clin Pharmacol Ther. 2017;101(6):721-724.
22.Clemens PL, Yan X, Lokhorst HM, et al. Pharmacokinetics of daratumumab follow- ing intravenous infusion in relapsed or refrac- tory multiple myeloma after prior protea- some inhibitor and immunomodulatory drug treatment. Clin Pharmacokinet. 2017;56(8):915-924.
23. Wang DD, Zhang S, Zhao H, Men AY, Parivar K. Fixed dosing versus body size- based dosing of monoclonal antibodies in adult clinical trials. J Clin Pharmacol. 2009;49(9):1012-1024.
24. Bai S, Jorga K, Xin Y, et al. A guide to rational dosing of monoclonal antibodies. Clin Pharmacokinet. 2012;51(2):119-135.
25. Mateos MV, Usmani SZ, Grosicki S, et al. Randomized, open-label, non-inferiority, phase 3 study of subcutaneous (SC) versus intravenous (IV) daratumumab (DARA) administration in patients (pts) with relapsed or refractory multiple myeloma (RRMM): body weight subgroup analysis of COLUM- BA. Presented at: the 61st American Society of Hematology (ASH) Annual Meeting & Exposition; December 7-10, 2019; Orlando, FL. Abstract 1906.
26. European Medicines Agency. MabThera: EPAR – product information; 2008.
27. European Medicines Agency. Herceptin: EPAR – product information; 2010.
28. HYQVIA [Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase] Solution for subcutaneous administration [package insert]. Westlake Village, CA: Baxalta US Inc.; 2016.
29. Palumbo A, Chanan-Khan A, Weisel K, et al. Daratumumab, bortezomib, and dexam- ethasone for multiple myeloma. N Engl J Med. 2016;375(8):754-766.
30. Dimopoulos MA, Oriol A, Nahi H, et al. Daratumumab, lenalidomide, and dexam- ethasone for multiple myeloma. N Engl J Med. 2016;375(14):1319-1331.
31.Usmani SZ, Weiss BM, Plesner T, et al. Clinical efficacy of daratumumab monother- apy in patients with heavily pretreated relapsed or refractory multiple myeloma.
Blood. 2016;128(1):37-44.
32. Plesner T, Arkenau HT, Gimsing P, et al.
Phase 1/2 study of daratumumab, lenalido- mide, and dexamethasone for relapsed mul- tiple myeloma. Blood. 2016;128(14):1821- 1828.
33. Chari A, Mark TM, Krishnan A, et al. Use of montelukast to reduce infusion reactions in an early access treatment protocol of daratu- mumab in United States patients with relapsed or refractory multiple myeloma. Presented at: the 58th American Society of Hematology (ASH) Annual Meeting & Exposition; December 3-6, 2016; San Diego, CA. Abstract 2142.
34.
Chari A, Suvannasankha A, Fay JW, et al. Daratumumab plus pomalidomide and dex- amethasone in relapsed and/or refractory multiple myeloma. Blood. 2017;130(8):974- 981.
35.Lonial S, Weiss BM, Usmani S, 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.
36. Mateos MV, Nahi H, Legiec W, et al. Efficacy and safety of the randomized, open-label, non-inferiority, phase 3 study of subcuta- neous (SC) versus intravenous (IV) daratu- mumab (DARA) administration in patients (pts) with relapsed or refractory multiple myeloma (RRMM): COLUMBA. Presented at: the Annual Meeting of the American Society of Clinical Oncology (ASCO); May 31-June 4, 2019; Chicago, IL. Abstract 8005.
37. Sonneveld P, Terpos E, Dimopolous M, et al. Pomalidomide and dexamethasone (pom- dex) with or without daratumumab (DARA) in patients (pts) with relapsed or refractory multiple myeloma (RRMM): a multicenter, randomized, phase 3 study (APOLLO). Presented at: the Annual Meeting of the American Society of Clinical Oncology (ASCO); June 1-5, 2018; Chicago, IL. Abstract TPS8059.
38. Rajkumar SV, Voorhees PM, Goldschmidt H, et al. Randomized, open-label, phase 3 study of subcutaneous daratumumab (DARA SC) versus active monitoring in patients (pts) with high-risk smoldering multiple myeloma (SMM): AQUILA. J Clin Oncol. 2018;36(15 Suppl):TPS8062.
39. Comenzo RL, Kastritis E, Mauer M, et al. Subcutaneous daratumumab + cyclophos- phamide, bortezomib, and dexamethasone (CyBorD) in patients with newly diagnosed amyloid light chain (AL) amyloidosis: updat- ed safety run-in results of ANDROMEDA. Presented at: the 24th European Hematology Association (EHA) Annual Congress; June 13-16, 2019; Amsterdam, The Netherlands. Abstract S875.
40. Usmani SZ, Mateos MV, Hungria V, et al. Greater treatment satisfaction in patients receiving subcutaneous versus intravenous daratumumab for relapsed or refractory mul- tiple myeloma: COLUMBA. Presented at: the 17th International Myeloma Workshop (IMW); September 12-15, 2019; Boston MA. Abstract SP-084.
41. Chari A, San-Miguel J, McCarthy H, et al. Subcutaneous (SC) daratumumab (DARA) in combination with standard multiple myelo- ma (MM) treatment regimens: an open-label, multicenter phase 2 study (PLEIADES). Presented at: the 17th International Myeloma Workshop (IMW); September 12- 15, 2019; Boston, MA. Abstract OAB-022.
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