Daratumumab, bortezomib, and dexamethasone for multiple myeloma

New England Journal of Medicine

Volumn 375, Issue 8, 2016, Pages 754-766

  Palumbo, Antonio ^a   Chanan Khan, Asher ^b   Weisel, Katja ^c   Nooka, Ajay K ^e   Masszi, Tamas ^f   Beksac, Meral ^g   Spicka, Ivan ^h   Hungria, Vania ⁱ   Munder, Markus ^d   Mateos, Maria V ^j   Mark, Tomer M ^k   Qi, Ming ^l   Schecter, Jordan ^m   Amin, Himal ^m   Qin, Xiang ^l   Deraedt, William ^l   Ahmadi, Tahamtan ^l   Spencer, Andrew ⁿ   Sonneveld, Pieter ^o  

^a UNIVERSITY OF TURIN   (Italy)

^b MAYO CLINIC   (United States)

^c UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

^d JOHANNES GUTENBERG UNIVERSITY   (Germany)

^e EMORY UNIVERSITY   (United States)

^f SEMMELWEIS UNIVERSITY   (Hungary)

^g ANKARA UNIVERSITY   (Turkey)

^h CHARLES UNIVERSITY   (Czech Republic)

ⁱ IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE SÃO PAULO   (Brazil)

^j HOSPITAL UNIVERSITARIO DE SALAMANCA   (Spain)

^k WEILL CORNELL MEDICAL COLLEGE   (United States)

^l JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^m JANSSEN RESEARCH AND DEVELOPMENT   (United States)

ⁿ MONASH UNIVERSITY   (Australia)

^o ERASMUS MEDICAL CENTER   (Netherlands)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BORTEZOMIB; DARATUMUMAB; DEXAMETHASONE; ANTINEOPLASTIC AGENT; CD38 ANTIGEN; MONOCLONAL ANTIBODY;

ADULT; AGED; ANEMIA; ARTICLE; ASTHENIA; BRONCHOSPASM; CONSTIPATION; CONTROLLED STUDY; COUGHING; DIARRHEA; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; FATIGUE; FEMALE; FEVER; HUMAN; HYPERTENSION; INFUSION RELATED REACTION; INSOMNIA; LARYNX EDEMA; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; METASTASIS; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MULTIPLE MYELOMA; NEUTROPENIA; OVERALL SURVIVAL; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RASH; SENSORY NEUROPATHY; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT RESPONSE; TREATMENT WITHDRAWAL; UPPER RESPIRATORY TRACT INFECTION; ANTAGONISTS AND INHIBITORS; CLINICAL TRIAL; DISEASE FREE SURVIVAL; DRUG RESISTANCE; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; RECURRENT DISEASE;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTIGENS, CD38; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BORTEZOMIB; DEXAMETHASONE; DISEASE-FREE SURVIVAL; DRUG RESISTANCE, NEOPLASM; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; MULTIPLE MYELOMA; RECURRENCE;

EID: 84984680198     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1606038     Document Type: Article

References (32)

1. Röllig C, Knop S, Bornhäuser M. Multiple myeloma. Lancet 2015;385:2197-208.
2. Rajkumar SV, Kumar S. Multiple myeloma: diagnosis and treatment. Mayo Clin Proc 2016;91:101-19.
3. Anderson KC, Alsina M, Atanackovic D, et al. NCCN guidelines insights: multiple myeloma, version 3.2016. J Natl Compr Canc Netw 2016;14:389-400.
4. Robinson R, Kaura S, Kiely D, Hussein MA, Nersesyan K, Durie BG. Impact of novel treatments on multiple myeloma survival. Blood 2014;124:5676.
5. Santonocito AM, Consoli U, Bagnato S, et al. Flow cytometric detection of aneuploid CD38(++) plasmacells and CD19(+) B-lymphocytes in bone marrow, peripheral blood and PBSC harvest in multiple myeloma patients. Leuk Res 2004;28:469-77.
6. Lin P, Owens R, Tricot G, Wilson CS. Flow cytometric immunophenotypic analysis of 306 cases of multiple myeloma. Am J Clin Pathol 2004;121:482-8.
7. Lammerts van Bueren JJ, Jakobs D, Kaldenhoven N, et al. Direct in vitro comparison of daratumumab with surrogate analogs of CD38 antibodies MOR03087, SAR650984 and Ab79. Presented at the American Society of Hematology 56th Annual Meeting and Exposition, San Francisco, December 6-9, 2014. abstract.
8. Jansen JHM, Boross P, Overdijk MB, Lammerts van Bueren JJ, Parren PWHI, Leusen HHW. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking. Presented at the American Society of Hematology 54th Annual Meeting and Exposition, Atlanta, December 8-11, 2012. abstract.
9. de Weers M, Tai YT, van der Veer MS, et al. Daratumumab, a novel therapeutic human CD38 monoclonal antibody, induces killing of multiple myeloma and other hematological tumors. J Immunol 2011;186:1840-8.
10. Overdijk MB, Verploegen S, Bögels M, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs 2015;7:311-21.
11. Krejcik J, Casneuf T, Nijhof IS, et al. Daratumumab depletes CD38+ immuneregulatory cells, promotes T-cell expansion, and skews T-cell repertoire in multiple myeloma. Blood 2016;128:384-94.
12. Usmani SZ, Weiss BM, Plesner T, et al. Clinical efficacy of daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma. Blood 2016;128:37-44.
13. McKeage K. Daratumumab: first global approval. Drugs 2016;76:275-81.
14. Mateos MV, Moreau P, Comenzo R, et al. An open-label, multicenter, phase 1b study of daratumumab in combination with pomalidomide-dexamethasone and with backbone regimens in patients with multiple myeloma. Presented at the 20th Congress of the European Hematology Association, Vienna, June 11-14, 2015.
15. Chari A, Lonial S, Suvannasankha A, et al. Open-label, multicenter, phase 1b study of daratumumab in combination with pomalidomide and dexamethasone in patients with at least 2 lines of prior therapy and relapsed or relapsed and refractory multiple myeloma (MM). Presented at the American Society of Hematology 56th Annual Meeting and Exposition, San Francisco, December 6-9, 2015.
16. Durie BG, Harousseau JL, Miguel JS, et al. International uniform response criteria for multiple myeloma. Leukemia 2006;20:1467-73.
17. Rajkumar SV, Harousseau JL, Durie B, et al. Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1. Blood 2011;117:4691-5.
18. Richardson PG, Barlogie B, Berenson J, et al. A phase 2 study of bortezomib in relapsed, refractory myeloma. N Engl J Med 2003;348:2609-17.
19. 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;387:1551-60.
20. Durie BG, Miguel JF, Blade J, Rajkumar SV. Clarification of the definition of complete response in multiple myeloma. Leukemia 2015;29:2416-7.
21. McCudden C, Axel AE, Slaets D, et al. Monitoring multiple myeloma patients treated with daratumumab: teasing out monoclonal antibody interference. Clin Chem Lab Med 2016;54:1095-104.
22. DeMets DL, Lan G. The alpha spending function approach to interim data analyses. Cancer Treat Res 1995;75:1-27.
23. Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983;70:659-63.
24. Plesner T, Arkenau HT, Lokhorst HM, et al. Daratumumab in combination with lenalidomide and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: updated results of a phase 1/2 study (GEN503). Presented at the American Society of Hematology 57th Annual Meeting and Exposition, Orlando, FL, December 5-8, 2015. abstract.
25. Lonial S, Mitsiades CS, Richardson PG. Treatment options for relapsed and refractory multiple myeloma. Clin Cancer Res 2011;17:1264-77.
26. Endell J, Samuelsson C, Boxhammer R, Strauss S, Steidl S. Effect of MOR202, a human CD38 antibody, in combination with lenalidomide and bortezomib, on bone lysis and tumor load in a physiologic model of myeloma. Presented at the 2011 American Society of Clinical Oncology Annual Meeting, Chicago, June 3-7, 2011. abstract.
27. van der Veer MS, de Weers M, van Kessel B, et al. The therapeutic human CD38 antibody daratumumab improves the antimyeloma effect of newly emerging multidrug therapies. Blood Cancer J 2011;1(10):e41.
28. Dimopoulos MA, Richardson PG, Moreau P, Anderson KC. Current treatment landscape for relapsed and/or refractory multiple myeloma. Nat Rev Clin Oncol 2015;12:42-54.
29. Dimopoulos MA, Moreau P, Palumbo A, et al. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. Lancet Oncol 2016;17:27-38.
30. San-Miguel JF, Hungria VT, Yoon SS, et al. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicentre, randomised, double-blind phase 3 trial. Lancet Oncol 2014;15:1195-206.
31. Jakubowiak A, Offidani M, Pégourie B, et al. Randomized phase 2 study: elotuzumab plus bortezomib/dexamethasone vs bortezomib/dexamethasone for relapsed/refractory MM. Blood 2016;127:2833-40.
32. Lokhorst HM, Plesner T, Laubach JP, et al. Targeting CD38 with daratumumab monotherapy in multiple myeloma. N Engl J Med 2015;373:1207-19.