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Immunotherapeutics – Product Review

Anti CD38 monoclonal antibodies for multiple myeloma treatment

ORCID Icon, , , , , & ORCID Icon show all
Article: 2052658 | Received 25 Nov 2021, Accepted 07 Mar 2022, Published online: 11 Apr 2022

References

  • Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;71(1):7–9. doi:10.3322/caac.21654. PMID 33433946
  • Gozzetti A, Le Beau MM. Fluorescence in situ hybridization: uses and limitations. Semin Hematol. 2000;37(4):320–33. doi:10.1016/s0037-1963(00)90013-1. PMID:11071355
  • Gozzetti A, Candi V, Papini G, Bocchia M. Therapeutic advancements in multiple myeloma. Front Oncol. 2014;4:241. doi:10.3389/fonc.2014.00241. PMID: 25237651
  • Ocio EM, Richardson PG, Rajkumar SV, Palumbo A, Mateos MV, Orlowski R, Kumar S, Usmani S, Roodman D, Niesvizky R, et al. New drugs and novel mechanisms of action in multiple myeloma in 2013: a report from the International Myeloma Working Group (IMWG). Leukemia. 2014;28(3):525–42. doi:10.1038/leu.2013.350. PMID: 24253022
  • Mohty M, Terpos E, Mateos MV, Cavo M, Lejniece S, Beksac M, Bekadja MA, Legiec W, Dimopoulos M, Stankovic S, et al. EMMOS investigators. Multiple myeloma treatment in real-world clinical practice: results of a prospective, multinational, noninterventional study. Clin Lymphoma Myeloma Leuk. 2018;18(10):e401–e419. doi:10.1016/j.clml.2018.06.018. PMID: 30030033
  • Kumar SK, Rajkumar SV, Dispenzieri A, Lacy MQ, Hayman SR, Buadi FK, Zeldenrust SR, Dingli D, Russell SJ, Lust JA, et al. Improved survival in multiple myeloma and the impact of novel therapies. Blood. 2008;111(5):2516–20. doi:10.1182/blood-2007-10-116129. PMID: 17975015
  • Castillo JJ, Jurczyszyn A, Brozova L, Crusoe E, Czepiel J, Davila J, Dispenzieri A, Eveillard M, Fiala MA, Ghobrial IM, et al. IgM myeloma: a multicenter retrospective study of 134 patients. Am J Hematol. 2017;92(8):746–51. doi:10.1002/ajh.24753. PMID: 28383205
  • Gozzetti A, Cerase A. Novel agents in CNS myeloma treatment. Cent Nerv Syst Agents Med Chem. 2014;14(1):23–27. doi:10.2174/1871524914999140818111514. PMID: 25134940
  • Gozzetti A, Cerase A, Lotti F, Rossi D, Palumbo A, Petrucci MT, Patriarca F, Nozzoli C, Cavo M, Offidani M, et al. GIMEMA (Gruppo Italiano Malattie Ematologiche dell’adulto) myeloma working party. Extramedullary intracranial localization of multiple myeloma and treatment with novel agents: a retrospective survey of 50 patients. Cancer. 2012 Mar 15; 118(6):1574–84. 10.1002/cncr.26447. Epub 2011 Aug 25. PMID: 21932386
  • Kocoglu MH, Badros AZ. Newly diagnosed multiple myeloma: current treatment strategies, emerging therapeutic approaches and beyond. Expert Rev Hematol. 2020 ;13(6):669–86. doi:10.1080/17474086.2020.1756258. PMID: 32290719.
  • Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, Munshi N, Lonial S, Bladé J, Mateos MV, et al. International myeloma working group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016 ;17(8):e328–e346. doi:10.1016/S1470-2045(16)30206-6. PMID: 27511158
  • Gozzetti A, Raspadori D, Bacchiarri F, Sicuranza A, Pacelli P, Ferrigno I, Tocci D, Bocchia M. Minimal residual disease in multiple myeloma: state of the art and applications in clinical practice. J Pers Med. 2020 Sep 10;10(3):120. 10.3390/jpm10030120. PMID: 32927719; PMCID: PMC7565263
  • Malavasi F, Funaro A, Roggero S, Horenstein A, Calosso L, Mehta K. Human CD38: a glycoprotein in search of a function. Immunol Today. 1994 ;15(3):95–97. doi:10.1016/0167-5699(94)90148-1. PMID: 8172650.
  • Funaro A, Reinis M, Trubiani O, Santi S, Di Primio R, Malavasi F. CD38 functions are regulated through an internalization step. J Immunol. 1998 Mar 1;160(5):2238–47. PMID: 9498763
  • Funaro A, Horenstein AL, Calosso L, Morra M, Tarocco RP, Franco L, De Flora A, Malavasi F. Identification and characterization of an active soluble form of human CD38 in normal and pathological fluids. Int Immunol. 1996 ;8(11):1643–50. doi:10.1093/intimm/8.11.1643. PMID: 8943558.
  • Deaglio S, Mehta K, Malavasi F. Human CD38: a (r)evolutionary story of enzymes and receptors. Leuk Res. 2001;25(1):1–12. doi:10.1016/S0145-2126(00)00093-X.
  • Cyster JG. Homing of antibody secreting cells. Immunol Rev. 2003;194(1):48–60. doi:10.1034/j.1600-065X.2003.00041.x.
  • Prosper F, Stroncek D, Verfaillie CM. Phenotypic and functional characterization of long-term culture-initiating cells present in peripheral blood progenitor collections of normal donors treated with granulocyte colony-stimulatingfactor. Blood. 1996;88(6):2033–42. doi:10.1182/blood.V88.6.2033.bloodjournal8862033.
  • Lee HC, Zocchi E, Guida L, Franco L, Benatti U, De Flora A. Production and hydrolysis of cyclic ADP-ribose at the outer surface of human erythrocytes. Biochem Biophys Res Commun. 1993 Mar 15;191(2):639–45. 10.1006/bbrc.1993.1265. PMID: 8461019
  • Zocchi E, Franco L, Guida L, Benatti U, Bargellesi A, Malavasi F, Lee HC, De Flora A. A single protein immunologically identified as CD38 displays NAD+ glycohydrolase, ADP-ribosyl cyclase and cyclic ADP-ribose hydrolase activities at the outer surface of human erythrocytes. Biochem Biophys Res Commun. 1993 Nov 15;196(3):1459–65. 10.1006/bbrc.1993.2416. PMID: 8250903
  • Ramaschi G, Torti M, Festetics ET, Sinigaglia F, Malavasi F, Balduini C. Expression of cyclic ADP-ribose-synthetizing CD38 molecule on human platelet membrane. Blood. 1996 Mar 15;87(6):2308–13. PMID: 8630392. 10.1182/blood.V87.6.2308.bloodjournal8762308
  • Xu Y, McKenna RW, Asplund SL, Kroft SH. Comparison of immunophenotypes of small B-cell neoplasms in primary lymph node and concurrent blood or marrow samples. Am J Clin Pathol. 2002 ;118(5):758–64. doi:10.1309/11J6-0U42-VF4E-WA02. PMID: 12428797.
  • Keyhani A, Huh YO, Jendiroba D, Pagliaro L, Cortez J, Pierce S, Pearlman M, Estey E, Kantarjian H, Freireich EJ. Increased CD38 expression is associated with favorable prognosis in adult acute leukemia. Leuk Res. 2000 ;24(2):153–59. doi:10.1016/s0145-2126(99)00147-2. PMID: 10654451.
  • Rodig SJ, Vergilio JA, Shahsafaei A, Dorfman DM. Characteristic expression patterns of TCL1, CD38, and CD44 identify aggressive lymphomas harboring a MYC translocation. Am J Surg Pathol. 2008 ;32(1):113–22. doi:10.1097/PAS.0b013e3180959e09. PMID: 18162778.
  • Krejcik J, Casneuf T, Nijhof IS, Verbist B, Bald J, Plesner T, Syed K, Liu K, van de Donk NW, Weiss BM, et al. Daratumumab depletes CD38+ immune regulatory cells, promotes T-cell expansion, and skews T-cell repertoire in multiple myeloma. Blood. 2016 Jul 21; 128(3):384–94. 10.1182/blood-2015-12-687749. Epub 2016 May 24. PMID: 27222480
  • Malavasi F, Deaglio S, Funaro A, Ferrero E, Horenstein AL, Ortolan E, Vaisitti T, Aydin S. Evolution and function of the ADP ribosyl cyclase/cd38 gene family in physiology and pathology. Physiol Rev. 2008 ;88(3):841–86. doi:10.1152/physrev.00035.2007.
  • Lin P, Owens R, Tricot G, Wilson CS. Flow cytometric immunophenotypic analysis of 306 cases of multiple myeloma. Am J Clin Pathol. 2004 ;121(4):482–88. doi:10.1309/74R4-TB90-BUWH-27JX.
  • Lee HC. Structure and enzymatic functions of human CD38. Mol Med. 2006;12(11–12):317–23. doi:10.2119/2006-00086.Lee.
  • Damle RN, Wasil T, Fais F, Ghiotto F, Valetto A, Allen SL, Buchbinder A, Budman D, Dittmar K, Kolitz J, et al. Ig V gene mutation status and CD38 expression as novel prognostic indicators in chronic lymphocytic leukemia. Blood. 1999 Sep 15;94(6):1840–47. PMID: 10477712. 10.1182/blood.V94.6.1840
  • Chini EN, Chini CC, Kato I, Takasawa S, Okamoto H. CD38 is the major enzyme responsible for synthesis of nicotinic acid-adenine dinucleotide phosphate in mammalian tissues. Biochem J. 2002 Feb 15;362(Pt 1):125–30. 10.1042/0264-6021:3620125. PMID: 11829748
  • Howard M, Grimaldi JC, Bazan JF, Lund FE, Santos-Argumedo L, Parkhouse RM, Walseth TF, Lee HC. Formation and hydrolysis of cyclic ADP-ribose catalyzed by lymphocyte antigen CD38. Science. 1993 Nov 12;262(5136):1056–59. 10.1126/science.8235624. PMID: 8235624
  • Takasawa S, Tohgo A, Noguchi N, Koguma T, Nata K, Sugimoto T, Yonekura H, Okamoto H. Synthesis and hydrolysis of cyclic ADP-ribose by human leukocyte antigen CD38 and inhibition of the hydrolysis by ATP. J Biol Chem. 1993 Dec 15;268(35):26052–54.
  • Barr H, Dempsey J, Waller A, Huang Y, Williams N, Sharma N, Benson DM, Rosko AE, Efebera YA, Hofmeister CC Ninety-Minute daratumumab infusion is safe in multiple myeloma. Leukemia. 2018;32(11):2495–518. doi:10.1038/s41375-018-0120-2. Epub 2018 Mar 31. PMID: 29679038.
  • Gozzetti A, Bacchiarri F, Sammartano V, Defina M, Sicuranza A, Mecacci B, Zappone E, Cencini E, Fabbri A, Raspadori D, et al. Long-term safety of rapid Daratumumab infusions in multiple myeloma patients. Front Oncol. 2020;10:570187. doi:10.3389/fonc.2020.570187. PMID: 33415072.
  • Overdijk MB, Verploegen S, Bögels M, van Egmond M, Lammerts van Bueren JJ, Mutis T, Groen RW, Breij E, Martens AC, Bleeker WK, 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):311–21. doi:10.1080/19420862.2015.1007813. PMID: 25760767.
  • Overdijk MB, Jansen JH, Nederend M, van Bueren JJ L, Groen RW, Parren PW, Leusen JH, Boross P. The therapeutic CD38 monoclonal antibody Daratumumab induces programmed cell death via Fcγ receptor-mediated cross-linking. J Immunol. 2016 Aug 1;197(3):807–13. 10.4049/jimmunol.1501351. Epub 2016 Jun 17. PMID: 27316683
  • van der Veer MS, de Weers M, van Kessel B, Bakker JM, Wittebol S, Parren PW, Lokhorst HM, Mutis T The therapeutic human CD38 antibody daratumumab improves the anti-myeloma effect of newly emerging multi-drug therapies. Blood Cancer J. 2011 ;1(10):e41. doi:10.1038/bcj.2011.42. Epub 2011 Oct 28. PMID: 22829073.
  • Busch L, Mougiakakos D, Büttner-Herold M, Müller MJ, Volmer DA, Bach C, Fabri M, Bittenbring JT, Neumann F, Boxhammer R, et al. Lenalidomide enhances MOR202-dependent macrophage-mediated effector functions via the vitamin D pathway. Leukemia. 2018 ;32(11):2445–58. 10.1038/s41375-018-0114-0. Epub 2018 Mar 28. PMID: 29654274
  • Lokhorst HM, Plesner T, Laubach JP, Nahi H, Gimsing P, Hansson M, Minnema MC, Lassen U, Krejcik J, Palumbo A, et al. Targeting CD38 with Daratumumab monotherapy in multiple myeloma. N Engl J Med. 2015 Sep 24;373(13):1207–19. 10.1056/NEJMoa1506348. Epub 2015 Aug 26. PMID: 26308596
  • Usmani SZ, Weiss BM, Plesner T, Bahlis NJ, Belch A, Lonial S, Lokhorst HM, Voorhees PM, Richardson PG, Chari A, et al. Clinical efficacy of daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma. Blood. 2016 Jul 7;128(1):37–44. 10.1182/blood-2016-03-705210. Epub 2016 May 23. PMID: 27216216; PMCID: PMC4937359
  • Usmani SZ, Nahi H, Plesner T, Weiss BM, Bahlis NJ, Belch A, Voorhees PM, Laubach JP, van de Donk NWCJ, Ahmadi T, et al. Daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma: final results from the phase 2 GEN501 and SIRIUS trials. Lancet Haematol. 2020 ;7(6):e447–e455. 10.1016/S2352-3026(20)30081-8. PMID: 32470437
  • Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis NJ, Usmani SZ, Rabin N, Orlowski RZ, Komarnicki M, Suzuki K, et al. POLLUX investigators. Daratumumab, Lenalidomide, and Dexamethasone for multiple myeloma. N Engl J Med. 2016 Oct 6;375(14):1319–31. 10.1056/NEJMoa1607751. PMID: 27705267
  • Palumbo A, Chanan-Khan A, Weisel K, Nooka AK, Masszi T, Beksac M, Spicka I, Hungria V, Munder M, Mateos MV, et al. CASTOR investigators. Daratumumab, Bortezomib, and Dexamethasone for multiple myeloma. N Engl J Med. 2016 Aug 25;375(8):754–66. 10.1056/NEJMoa1606038. PMID: 27557302
  • Chari A, Suvannasankha A, Fay JW, Arnulf B, Kaufman JL, Ifthikharuddin JJ, Weiss BM, Krishnan A, Lentzsch S, Comenzo R, et al. Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Blood. 2017 Aug 24;130(8):974–81. 10.1182/blood-2017-05-785246. Epub 2017 Jun 21. PMID: 28637662; PMCID: PMC5570682
  • Dimopoulos M, Quach H, Mateos MV, Landgren O, Leleu X, Siegel D, Weisel K, Yang H, Klippel Z, Zahlten-Kumeli A, 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(10245):186–97. doi:10.1016/S0140-6736(20)30734-0. Erratum in: Lancet. 2020 Aug 15;396(10249):466. PMID: 32682484
  • Moreau P, Attal M, Hulin C, Arnulf B, Belhadj K, Benboubker L, Béné MC, Broijl A, Caillon H, Caillot D, 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)31240-1. Epub 2019 Jun 3. Erratum in: Lancet. 2019 Jun 14; PMID: 31171419
  • Mateos MV, Cavo M, Blade J, Dimopoulos MA, Suzuki K, Jakubowiak A, Knop S, Doyen C, Lucio P, Nagy Z, 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 Jan 11;395(10218):132–41. 10.1016/S0140-6736(19)32956-3. Epub 2019 Dec 10. PMID: 31836199
  • Mateos MV, Nahi H, Legiec W, Grosicki S, Vorobyev V, Spicka I, Hungria V, Korenkova S, Bahlis N, Flogegard M, 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. 10.1016/S2352-3026(20)30070-3. Epub 2020 Mar 23
  • Dimopoulos MA, Terpos E, Boccadoro M, Delimpasi S, Beksac M, Katodritou E, Moreau P, Baldini L, Symeonidis A, Bila J, et al. APOLLO trial investigators. 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):801–12. 10.1016/S1470-2045(21)00128-5. PMID: 34087126
  • Facon T, Kumar S, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, et al. MAIA trial investigators. Daratumumab plus Lenalidomide and Dexamethasone for untreated myeloma. N Engl J Med. 2019 May 30;380(22):2104–15. 10.1056/NEJMoa1817249. PMID: 31141632
  • Voorhees PM, Kaufman JL, Laubach J, Sborov DW, Reeves B, Rodriguez C, Chari A, Silbermann R, Costa LJ, Ld A Jr, et al. Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial. Blood. 2020 Aug 20;136(8):936–45. 10.1182/blood.2020005288. PMID: 32325490
  • Mateos MV, Kumar S, Dimopoulos MA, González-Calle V, Kastritis E, Hajek R, De Larrea CF, Morgan GJ, Merlini G, Goldschmidt H, et al. International myeloma working group risk stratification model for smoldering multiple myeloma (SMM). Blood Cancer J. 2020 Oct 16;10(10):102. 10.1038/s41408-020-00366-3. PMID: 33067414; PMCID: PMC7567803
  • Landgren CO, Chari A, Cohen YC, Spencer A, Voorhees P, Estell JA, Sandhu I, Jenner MW, Williams C, Cavo M, et al. Daratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS). Leukemia. 2020 ;34(7):1840–52. 10.1038/s41375-020-0718-z. Epub 2020 Feb 5. PMID: 32024950; PMCID: PMC7326703
  • Janssen. DARZALEX® (daratumumab) injection, for intravenous use [package insert]; [ accessed 2021 Nov] https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf
  • Zhu C, Song Z, Wang A, Srinivasan S, Yang G, Greco R, Theilhaber J, Shehu E, Wu L, Yang ZY, et al. Isatuximab acts through Fc-dependent, independent, and direct pathways to kill multiple myeloma cells. Front Immunol. 2020 Aug 14;11:1771. 10.3389/fimmu.2020.01771. PMID: 32922390; PMCID: PMC7457083
  • Feng X, Zhang L, Acharya C, An G, Wen K, Qiu L, Munshi NC, Tai YT, Anderson KC. Targeting CD38 suppresses induction and function of T Regulatory cells to mitigate immunosuppression in multiple myeloma. Clin Cancer Res. 2017 Aug 1;23(15):4290–300. 10.1158/1078-0432.CCR-16-3192. Epub 2017 Mar 1. PMID: 28249894; PMCID: PMC5540790
  • Song Z, Yang G, Wang A, Greco R, Theilhaber J, Shehu E, Ajona D, Paiva B, Zhu C, Wiederschain D et al. Isatuximab-Induced multiple myeloma cell killing through effector functions is dependent on CD38 expression and complement inhibitors. Cancer Res. 2019;79:13 Supplement.
  • Jiang H, Acharya C, An G, Zhong M, Feng X, Wang L, Dasilva N, Song Z, Yang G, Adrian F, et al. SAR650984 directly induces multiple myeloma cell death via lysosomal-associated and apoptotic pathways, which is further enhanced by pomalidomide. Leukemia. 2016 ;30(2):399–408. 10.1038/leu.2015.240. Epub 2015 Sep 4. PMID: 26338273
  • Tai YT, Anderson KC. Targeting CD38 alleviates tumor-induced immunosuppression. Oncotarget. 2017 Dec 26;8(68):112166–67. 10.18632/oncotarget.22992. PMID: 29348814; PMCID: PMC5762499
  • SanofI-Aventis. SARCLISA (isatuximab): EU summary of product characteristics; 2021 [accessed 2021 Apr 22]. https://www.ema.europa.eu
  • SanofI-Aventis. SARCLISA® (isatuximab-irfc): US prescribing information; 2021 [accessed 2021 Apr 22]. https://www.fda.gov/drugs
  • Martin T, Strickland S, Glenn M, Charpentier E, Guillemin H, Hsu K, Mikhael J. Phase I trial of isatuximab monotherapy in the treatment of refractory multiple myeloma. Blood Cancer J. 2019 Mar 29;9(4):41. 10.1038/s41408-019-0198-4. PMID: 30926770; PMCID: PMC6440961
  • Mikhael J, Richardson P, Usmani SZ, Raje N, Bensinger W, Karanes C, Campana F, Kanagavel D, Dubin F, Liu Q, et al. A phase 1b study of isatuximab plus pomalidomide/dexamethasone in relapsed/refractory multiple myeloma. Blood. 2019 Jul 11;134(2):123–33. 10.1182/blood-2019-02-895193. Epub 2019 Mar 12. PMID: 30862646; PMCID: PMC6659612
  • Usmani SZ, Karanes C, Bensinger WI, D’-Souza A, Raje N, Tuchman SA, Sborov D, Laubach JP, Bianchi G, Kanagavel D, et al. Final results of a phase 1b study of isatuximab short-duration fixed-volume infusion combination therapy for relapsed/refractory multiple myeloma. Leukemia. 2021 May 28. 10.1038/s41375-021-01262-w. Epub ahead of print. PMID: 34050260
  • Martin TG, Shah N, Richter J, Vesole DH, Wong SW, Huang CY, Madduri D, Jagannath S, Siegel DS, Biran N, et al. Phase 1b trial of isatuximab, an anti-CD38 monoclonal antibody, in combination with carfilzomib as treatment of relapsed/refractory multiple myeloma. Cancer. 2021 Jun 1;127(11):1816–26. 10.1002/cncr.33448. Epub 2021 Mar 18. PMID: 33735504; PMCID: PMC8252002
  • Martin T, Baz R, Benson DM, Lendvai N, Wolf J, Munster P, Lesokhin AM, Wack C, Charpentier E, Campana F, et al. A phase 1b study of isatuximab plus lenalidomide and dexamethasone for relapsed/refractory multiple myeloma. Blood. 2017 Jun 22;129(25):3294–303. 10.1182/blood-2016-09-740787. Epub 2017 May 8. PMID: 28483761; PMCID: PMC5482100
  • Attal M, Richardson PG, Rajkumar SV, San-Miguel J, Beksac M, Spicka I, Leleu X, Schjesvold F, Moreau P, Dimopoulos MA, et al; ICARIA-MM study group. 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 Dec 7;394(10214):2096–107. doi: 10.1016/S0140-6736(19)32556-5. Epub 2019 Nov 14. Erratum in: Lancet. 2019 Dec 7;394(10214):2072. PMID: 31735560.
  • Dimopoulos MA, Leleu X, Moreau P, Richardson PG, Liberati AM, Harrison SJ, Miles Prince H, Ocio EM, Assadourian S, Campana F, et al. Isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients with renal impairment: ICARIA-MM subgroup analysis. Leukemia. 2021 ;35(2):562–72. 10.1038/s41375-020-0868-z. PMID: 32444867; PMCID: PMC7862055
  • Moreau P, Dimopoulos MA, Mikhael J, Yong K, Capra M, Facon T, Hajek R, Špička I, Baker R, Kim K, et al. IKEMA study group. Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial. Lancet. 2021 Jun 19;397(10292):2361–71. 10.1016/S0140-6736(21)00592-4. PMID: 34097854
  • Boxhammer R, Weirather J, Steidl S, Endell J. MOR202, a human anti-CD38 monoclonal antibody, mediates potent tumoricidal activity in vivo and shows synergistic efficacy in combination with different antineoplastic compounds. Blood. 2015;126:3015.
  • Raab MS, Engelhardt M, Blank A, Goldschmidt H, Agis H, Blau IW, Einsele H, Ferstl B, Schub N, Röllig C, et al. MOR202, a novel anti-CD38 monoclonal antibody, in patients with relapsed or refractory multiple myeloma: a first-in-human, multicentre, phase 1-2a trial. Lancet Haematol. 2020 ;7(5):e381–e394. 10.1016/S2352-3026(19)30249-2. PMID: 32171061
  • Krishnan AY, Patel KK, Hari P, Jagannath S, Niesvizky R, Silbermann RW, Berg DT, Li Q, Allikmets K, Stockerl-Goldstein K. A phase Ib study of TAK-079, an investigational anti-CD38 monoclonal antibody (mAb) in patients with relapsed/refractory multiple myeloma (RRMM): preliminary results. J Clin Oncol 2020;38. doi:10.1200/JCO.2020.38.15_suppl.8539. Abstract #8539