A combination of carfilzomib, dexamethasone, and daratumumab for treatment of adult patients with relapsed/refractory multiple myeloma in two dosing regimens: once-weekly and twice-weekly

References

• Siegel, R. L., K. D. Miller, and A. Jemal. Cancer statistics, 2020. CA: A Cancer Journal for Clinicians. 2020;70: 7–30.
   PubMed Web of Science ®Google Scholar
• World Health Organization. International Agency for Research on Cancer: multiple myeloma fact sheet. 2018.
   Google Scholar
• Cid Ruzafa, J., E. Merinopoulou, R. F. Baggaley, et al. Patient population with multiple myeloma and transitions across different lines of therapy in the USA: an epidemiologic model. Pharmacoepidemiology and Drug Safety. 2016;25: 871–879.
   PubMed Web of Science ®Google Scholar
• Bazarbachi, A. H., R. Al Hamed, F. Malard, et al. Relapsed refractory multiple myeloma: a comprehensive overview. Leukemia. 2019;33: 2343–2357.
   PubMed Web of Science ®Google Scholar
• SARCLISA (Isatuximab-irfc). Full prescribing information, Sanofi-Aventis US LLC, Bridgewater, NJ, 2021.
   Google Scholar
• Kumar, S. K., T. M. Therneau, M. A. Gertz, et al. Clinical course of patients with relapsed multiple myeloma. Mayo Clinic Proceedings. Mayo Clinic. 2004;79: 867–874.
   PubMed Web of Science ®Google Scholar
• Sonneveld, P., and A. Broijl. Treatment of relapsed and refractory multiple myeloma. Haematologica. 2016;101: 396–406.
   PubMed Web of Science ®Google Scholar
• Chim, C. S., S. K. Kumar, R. Z. Orlowski, et al. Management of relapsed and refractory multiple myeloma: Novel agents, antibodies, immunotherapies and beyond. Leukemia. 2018;32: 252–262.
   PubMed Web of Science ®Google Scholar
• Chehab, S., E. H. Panjic, C. Gleason, et al. Daratumumab and its use in the treatment of relapsed and/or refractory multiple myeloma. Future Oncology. 2018;14: 3111–3121.
   PubMed Web of Science ®Google Scholar
• Lamb, Y. N. Elotuzumab: a review in relapsed and/or refractory multiple myeloma. Drugs. 2018;78: 1481–1488.
   PubMed Web of Science ®Google Scholar
• Holstein, S. A., and P. L. McCarthy. Immunomodulatory drugs in multiple myeloma: mechanisms of action and clinical experience. Drugs. 2017;77: 505–520.
   PubMed Web of Science ®Google Scholar
• Moreau, P., E. Zamagni, and M. V. Mateos. Treatment of patients with multiple myeloma progressing on frontline-therapy with lenalidomide. Blood Cancer Journal. 2019;9: 38.
   PubMed Web of Science ®Google Scholar
• Mateos, M. V., P. Sonneveld, V. Hungria, et al. Daratumumab, Bortezomib, and Dexamethasone versus Bortezomib and Dexamethasone in patients with previously treated multiple myeloma: three-year follow-up of CASTOR. Clinical Lymphoma, Myeloma & Leukemia. 2020b;20: 509–518.
   PubMed Web of Science ®Google Scholar
• Orlowski, R. Z., P. Moreau, R. Niesvizky, et al. Carfilzomib-dexamethasone versus bortezomib-dexamethasone in relapsed or refractory multiple myeloma: updated overall survival, safety, and subgroups. Clinical Lymphoma, Myeloma & Leukemia. 2019;19: 522–30.e1.
   PubMed Web of Science ®Google Scholar
• Richardson, P. G., A. Oriol, M. Beksac, et al. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): A randomised, open-label, phase 3 trial. The Lancet Oncology. 2019;20: 781–794.
   PubMed Web of Science ®Google Scholar
• Dimopoulos, M., H. Quach, M. V. Mateos, 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. The Lancet. 2020a;396: 186–197.
   PubMed Web of Science ®Google Scholar
• Kyprolis® (carfilzomib). Full Prescribing Information, Amgen Inc., Thousand Oaks, CA, 2020.
   Google Scholar
• Genmab. Genmab announces Janssen granted U.S. FDA approval for DARZALEX® (daratumumab) in combination with Carfilzomib and Dexamethasone in relapsed or refractory myeloma [Internet]. [ cited 2020 December 16]. Available from: https://www.globenewswire.com/news-release/2020/08/20/2081705/0/en/Genmab-Announces-Janssen-Granted-U-S-FDA-Approval-for-DARZALEX-daratumumab-in-Combination-with-Carfilzomib-and-Dexamethasone-in-Relapsed-or-Refractory-Multiple-Myeloma.html
   Google Scholar
• Kyprolis (carfilzomib). Summary of Product Characteristics, Amgen Ltd, Cambridge, UK, 2021.
   Google Scholar
• Kyprolis (carfilzomib for injection). In: Product Monograph Mississauga. Ontario: Amgen Canada Inc. 2021.
   Google Scholar
• DARZALEX® (daratumumab). Full Prescribing Information, Janssen Biotech, Inc., Horsham, PA 19044, 2020.
   Google Scholar
• Moreau, P., S. K. Kumar, J. San Miguel, et al. Treatment of relapsed and refractory multiple myeloma: recommendations from the international myeloma working group. The Lancet Oncology. 2021;22: e105–e18.
   PubMed Web of Science ®Google Scholar
• National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN Guidelines) - multiple myeloma (version 5.2021). 2021.
   Google Scholar
• Dimopoulos, M. A., P. Moreau, E. Terpos, et al. Multiple myeloma: EHA-ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Annals Of Oncology : Official Journal Of The European Society For Medical Oncology / ESMO. 2021;32: 309–322.
   PubMed Web of Science ®Google Scholar
• Rajkumar, S. V. Multiple myeloma: 2018 update on diagnosis, risk‐stratification, and management. American Journal of Hematology. 2018;93: 981–1114.
   PubMed Web of Science ®Google Scholar
• Fraz, M. A., F. H. Warraich, S. U. Warraich, et al. Special considerations for the treatment of multiple myeloma according to advanced age, comorbidities, frailty and organ dysfunction. Critical Reviews in Oncology/Hematology. 2019;137: 18–26.
   PubMed Web of Science ®Google Scholar
• Bobin, A., E. Liuu, N. Moya, et al. Multiple myeloma: an overview of the current and novel therapeutic approaches in 2020. Cancers (Basel). 2020;12:2885.
   Web of Science ®Google Scholar
• Al Saleh, A. S., T. Sher, and M. A. Gertz. Multiple myeloma in the time of COVID-19. Acta Haematologica. 2020;143: 410–416.
   PubMed Web of Science ®Google Scholar
• Abdi, J., G. Chen, and H. Chang. Drug resistance in multiple myeloma: latest findings and new concepts on molecular mechanisms. Oncotarget. 2013; 4: 2186–2207.
   PubMed Web of Science ®Google Scholar
• Mikhael, J. Treatment options for triple-class refractory multiple myeloma. Clinical Lymphoma, Myeloma & Leukemia. 2020;20: 1–7.
   PubMed Web of Science ®Google Scholar
• Chari, A., D. T. Vogl, M. Gavriatopoulou, et al. Oral selinexor-dexamethasone for triple-class refractory multiple myeloma. The New England Journal of Medicine. 2019c;381: 727–738.
   PubMed Web of Science ®Google Scholar
• XPOVIO (selinexor). Full Prescribing Information, Karyopharm Therapeutics Inc., Newton, MA, 2020.
   Google Scholar
• Podar, K., J. Shah, A. Chari, et al. Selinexor for the treatment of multiple myeloma. Expert Opinion on Pharmacotherapy. 2020;21: 399–408.
   PubMed Web of Science ®Google Scholar
• VENCLEXTA (venetoclax tablets). Full Prescribing Information, AbbVie Inc., North Chicago, IL, 2020.
   Google Scholar
• Vaxman, I., M. H. Sidiqi, and M. Gertz. Venetoclax for the treatment of multiple myeloma. Expert Review of Hematology. 2018;11: 915–920.
   PubMed Web of Science ®Google Scholar
• Abramson, H. N. Monoclonal antibodies for the treatment of multiple myeloma: an update. International Journal of Molecular Sciences. 2018;19: 3924.
   Web of Science ®Google Scholar
• BLENREP (belantamab mafodotin-blmf). Full Prescribing Information, GlaxoSmithKline, Research Triangle Park, NC, 2020.
   Google Scholar
• Tai, Y. T., and K. C. Anderson. B cell maturation antigen (BCMA)-based immunotherapy for multiple myeloma. Expert Opinion on Biological Therapy. 2019;19: 1143–1156.
   PubMed Web of Science ®Google Scholar
• Verkleij, C. P. M., K. A. Frerichs, M. Broekmans, et al. T-cell redirecting bispecific antibodies targeting BCMA for the treatment of multiple myeloma. Oncotarget. 2020;11: 4076–4081.
   PubMedGoogle Scholar
• Pillarisetti, K., S. Edavettal, M. Mendonça, et al. A T-cell-redirecting bispecific G-protein-coupled receptor class 5 member D x CD3 antibody to treat multiple myeloma. Blood. 2020;135: 1232–1243.
   PubMed Web of Science ®Google Scholar
• Ovacik, A. M., J. Li, M. Lemper, et al. Single cell-produced and in vitro-assembled anti-FcRH5/CD3 T-cell dependent bispecific antibodies have similar in vitro and in vivo properties. MAbs. 2019;11: 422–433.
   PubMed Web of Science ®Google Scholar
• Landgren, O., and K. Iskander. Modern multiple myeloma therapy: deep, sustained treatment response and good clinical outcomes. Journal of Internal Medicine. 2017;281: 365–382.
   PubMed Web of Science ®Google Scholar
• Groen, K., N. van de Donk, C. Stege, et al. Carfilzomib for relapsed and refractory multiple myeloma. Cancer Management and Research. 2019;11: 2663–2675.
   PubMed Web of Science ®Google Scholar
• Tan, C. R. C., S. Abdul-Majeed, B. Cael, et al. Clinical pharmacokinetics and pharmacodynamics of Bortezomib. Clinical Pharmacokinetics. 2019;58: 157–168.
   PubMed Web of Science ®Google Scholar
• Andreu-Vieyra, C., and J. R. Berenson. Carfilzomib in multiple myeloma. Expert Opinion on Biological Therapy. 2014;14: 1685–1699.
   PubMed Web of Science ®Google Scholar
• Kuhn, D. J., Q. Chen, P. M. Voorhees, et al. Potent activity of carfilzomib, a novel, irreversible inhibitor of the ubiquitin-proteasome pathway, against preclinical models of multiple myeloma. Blood. 2007;110: 3281–3290.
   PubMed Web of Science ®Google Scholar
• Alsina, M., S. Trudel, R. R. Furman, et al. A phase I single-agent study of twice-weekly consecutive-day dosing of the proteasome inhibitor carfilzomib in patients with relapsed or refractory multiple myeloma or lymphoma. Clinical Cancer Research : An Official Journal of the American Association for Cancer Research. 2012;18: 4830–4840.
   PubMed Web of Science ®Google Scholar
• O’Connor, O. A., A. K. Stewart, M. Vallone, et al. A phase 1 dose escalation study of the safety and pharmacokinetics of the novel proteasome inhibitor carfilzomib (PR-171) in patients with hematologic malignancies. Clinical Cancer Research : An Official Journal of the American Association for Cancer Research. 2009;15: 7085–7091.
   PubMed Web of Science ®Google Scholar
• Burwick, N., and S. Sharma. Glucocorticoids in multiple myeloma: past, present, and future. Annals of Hematology. 2019;98: 19–28.
   PubMed Web of Science ®Google Scholar
• Czock, D., F. Keller, F. M. Rasche, et al. Pharmacokinetics and pharmacodynamics of systemically administered glucocorticoids. Clinical Pharmacokinetics. 2005;44: 61–98.
   PubMed Web of Science ®Google Scholar
• de Weers, M., Y. T. Tai, M. S. van der Veer, et al. Daratumumab, a novel therapeutic human CD38 monoclonal antibody, induces killing of multiple myeloma and other hematological tumors. Journal of Immunology (Baltimore, Md. : 1950). 2011;186: 1840–1848.
   PubMed Web of Science ®Google Scholar
• Sanchez, L., Y. Wang, D. S. Siegel, et al. Daratumumab: a first-in-class CD38 monoclonal antibody for the treatment of multiple myeloma. Journal of Hematology & Oncology. 2016;9: 51.
   PubMed Web of Science ®Google Scholar
• Krejcik, J., T. Casneuf, I. S. Nijhof, et al. Daratumumab depletes CD38+ immune regulatory cells, promotes T-cell expansion, and skews T-cell repertoire in multiple myeloma. Blood. 2016;128: 384–394.
   PubMed Web of Science ®Google Scholar
• van de Donk, N., P. G. Richardson, and F. Malavasi. CD38 antibodies in multiple myeloma: back to the future. Blood. 2018;131: 13–29.
   PubMed Web of Science ®Google Scholar
• Lokhorst, H. M., T. Plesner, J. P. Laubach, et al. Targeting CD38 with daratumumab monotherapy in multiple myeloma. The New England Journal of Medicine. 2015;373: 1207–1219.
   PubMed Web of Science ®Google Scholar
• Lamb, Y. N. Daratumumab: a review in combination therapy for transplant-eligible newly diagnosed multiple myeloma. Drugs. 2020;80: 1455–1464.
   PubMed Web of Science ®Google Scholar
• DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj). Full prescribing information, Janssen Biotech, Inc., Horsham, PA, 2020.
   Google Scholar
• Mateos, M.-V., H. Nahi, W. Legiec, 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. The Lancet Haematology. 2020a;7: e370–e80.
   PubMed Web of Science ®Google Scholar
• Usmani, S. Z., H. Nahi, M. V. Mateos, et al. Subcutaneous delivery of daratumumab in relapsed or refractory multiple myeloma. Blood. 2019;134: 668–677.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Assessment Report: Darzalex. European Medicines Agency. Amsterdam, Netherlands. 2020a; European Medicines Agency. Darzalex (daratumumab): An overview of Darzalex and why it is authorised in the EU. European Medicines Agency. Amsterdam, Netherlands. 2020b.
   Google Scholar
• Chari, A., J. Martinez-Lopez, M. V. Mateos, et al. Daratumumab plus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma. Blood. 2019b;134: 421–431.
   PubMed Web of Science ®Google Scholar
• Chari, A., S. Lonial, J. Martinez-Lopez, et al. Final analysis of a phase 1b study of daratumumab in combination with carfilzomib and dexamethasone for relapsed or refractory multiple myeloma (RRMM). Blood. 2019a;134:1876.
   Web of Science ®Google Scholar
• Moreau, P., A. Chari, M. Haenel, et al Subcutaneous daratumumab (dara SC) plus standard-of-care (SOC) regimens in multiple myeloma (MM) across lines of therapy in the phase 2 pleiades study: Initial results of the dara SC plus carfilzomib/dexamethasone (D-Kd) cohort, and updated results for the dara SC plus bortezomib/melphalan/prednisone (D-VMP) and dara SC plus lenalidomide/dexamethasone (D-Rd) cohorts. Presented at: American Society of Hematology Annual Meeting and Exposition; 2020 December 5-8, 2020; Virtual.
   Google Scholar
• Leleu, X., M. Beksac, T. Chou, et al. Efficacy and safety of weekly carfilzomib (70 mg/m(2)), dexamethasone, and daratumumab (KdD70) is comparable to twice-weekly KdD56 while being a more convenient dosing option: a cross-study comparison of the CANDOR and EQUULEUS studies. Leukemia & Lymphoma. 2021;62: 358–367.
   PubMed Web of Science ®Google Scholar
• Markman, M. Cross-trial comparisons in the oncology arena: When is this justified?. Oncology. 2011;80: 151–152.
   PubMed Web of Science ®Google Scholar
• Signorovitch, J. E., E. Q. Wu, A. P. Yu, et al. Comparative effectiveness without head-to-head trials: A method for matching-adjusted indirect comparisons applied to psoriasis treatment with adalimumab or etanercept. Pharmacoeconomics. 2010;28: 935–945.
   PubMed Web of Science ®Google Scholar
• Weisel, K., A. Nooka, E. Terpos, et al. Carfilzomib 56mg/m2 twice-weekly in combination with dexamethasone and daratumumab (KdD) versus Daratumumab in combination with 8 cycles of Bortezomib and Dexamethasone (DVd); a matching-adjusted indirect treatment comparison. Presented at: American Society of Hematology Annual Meeting and Exposition; 2020 December 5-8, 2020; Virtual.
   Google Scholar
• Spencer, A., S. Lentzsch, K. Weisel, et al. Daratumumab plus bortezomib and dexamethasone versus bortezomib and dexamethasone in relapsed or refractory multiple myeloma: Updated analysis of CASTOR. Haematologica. 2018;103: 2079–2087.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Kyprolis (carfilzomib): An overview of Kyprolis and why it is authorised in the EU. European Medicines Agency. Amsterdam, Netherlands. 2018.
   Google Scholar
• European Medicines Agency. Darzalex (daratumumab): An overview of Darzalex and why it is authorised in the EU. European Medicines Agency. Amsterdam, Netherlands. 2020b.
   Google Scholar
• Dimopoulos, M., E. Terpos, M. Boccadoro, et al. Apollo: Phase 3 randomized study of subcutaneous daratumumab plus pomalidomide and dexamethasone (D-Pd) versus pomalidomide and dexamethasone (Pd) alone in patients (pts) with relapsed/refractory multiple myeloma (RRMM). Presented at: 62nd American Society of Hematology Annual Meeting and Exposition; 2020 December 5- 8; Virtual.
   Google Scholar
• Dimopoulos, M. A., H. Quach, M.-V. Mateos, et al. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone in relapsed or refractory multiple myeloma: Updated efficacy and safety results of the phase 3 CANDOR study. Blood. 2020b;136: 26–27.
   Google Scholar
• Chari, A., M. K. Samur, J. Martinez-Lopez, et al. Clinical features associated with COVID-19 outcome in multiple myeloma: first results from the international myeloma society data set. Blood. 2020;136: 3033–3040.
   PubMed Web of Science ®Google Scholar
• Terpos, E., M. Engelhardt, G. Cook, et al. Management of patients with multiple myeloma in the era of COVID-19 pandemic: a consensus paper from the European Myeloma Network (EMN). Leukemia. 2020;34: 2000–2011.
   PubMed Web of Science ®Google Scholar
• Malard, F., and M. Mohty. Management of patients with multiple myeloma during the COVID-19 pandemic. The Lancet Haematol. 2020;7: e435–e7.
   PubMed Web of Science ®Google Scholar
• Isidori, A., L. De Leval, U. Gergis, et al. Management of patients with hematologic malignancies during the COVID-19 pandemic: practical considerations and lessons to be learned. Frontiers in Oncology. 2020;10: 1439.
   PubMed Web of Science ®Google Scholar
• Gardeney, H., A. Bobin, C. Gruchet, et al. Three drug combinations in the treatment of fit elderly multiple myeloma patients. Journal of Clinical Medicine. 2020;9:3554.
   Web of Science ®Google Scholar
• Ghosh, A., S. Mailankody, S. A. Giralt, et al. CAR T cell therapy for multiple myeloma: Where are we now and where are we headed?. Leukemia & Lymphoma. 2018;59(2056–67): 2056–2067.
   PubMedGoogle Scholar
• Richard, S., S. Jagannath, H. J. Cho, et al. A comprehensive overview of daratumumab and carfilzomib and the recently approved daratumumab, carfilzomib and dexamethasone regimen in relapsed/refractory multiple myeloma. Expert Review of Hematology. 2021;14:31–45.
   PubMed Web of Science ®Google Scholar