Daratumumab, lenalidomide, and dexamethasone for multiple myeloma

New England Journal of Medicine

Volumn 375, Issue 14, 2016, Pages 1319-1331

  Dimopoulos, M A ^a   Oriol, A ^b   Nahi, H ^d   San Miguel, J ^c   Bahlis, N J ^e   Usmani, S Z ^g   Rabin, N ^h   Orlowski, R Z ⁱ   Komarnicki, M ^j   Suzuki, K ^k   Plesner, T ^l   Yoon, S S ⁿ   Ben Yehuda, D ^o   Richardson, P G ^p   Goldschmidt, H ^q   Reece, D ^f   Lisby, S ^m   Khokhar, N Z ^r   O'Rourke, L ^r   Chiu, C ^r   Qin, X ^r   Guckert, M ^r   Ahmadi, T ^r   Moreau, P ^s   more..

^a UNIVERSITY OF ATHENS MEDICAL SCHOOL   (Greece)

^b HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL   (Spain)

^c UNIVERSITY CLINIC OF NAVARRA   (Spain)

^d KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^e UNIVERSITY OF CALGARY   (Canada)

^f PRINCESS MARGARET HOSPITAL   (Canada)

^g LEVINE CANCER INSTITUTE   (United States)

^h UNIVERSITY COLLEGE LONDON HOSPITALS   (United Kingdom)

ⁱ UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^j POZNAN UNIVERSITY OF MEDICAL SCIENCES   (Poland)

^k JAPANESE RED CROSS MEDICAL CENTER   (Japan)

^l UNIVERSITY OF SOUTHERN DENMARK   (Denmark)

^m Genmab   (Denmark)

ⁿ Seoul National University College of Medicine   (South Korea)

^o HADASSAH HEBREW UNIVERSITY MEDICAL CENTER   (Israel)

^p HARVARD MEDICAL SCHOOL   (United States)

^q UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

^r JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^s HÔTEL DIEU   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALKYLATING AGENT; BORTEZOMIB; DARATUMUMAB; DEXAMETHASONE; IMMUNOMODULATING AGENT; LENALIDOMIDE; PROTEASOME INHIBITOR; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY; THALIDOMIDE;

ADULT; AGED; ANEMIA; ARTICLE; ASTHENIA; AUTOLOGOUS STEM CELL TRANSPLANTATION; BACKACHE; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER MORTALITY; CANCER RECURRENCE; CLINICAL PROTOCOL; CONSTIPATION; CONTROLLED STUDY; COUGHING; DIARRHEA; DISEASE COURSE; DRUG EFFICACY; DYSPNEA; FATIGUE; FEBRILE NEUTROPENIA; FEVER; FOLLOW UP; HAZARD RATIO; HEMATOLOGIC DISEASE; HUMAN; INFUSION RELATED REACTION; INSOMNIA; KAPLAN MEIER METHOD; LEUKOCYTE; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MINIMAL RESIDUAL DISEASE; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE MYELOMA; MUSCLE SPASM; NAUSEA; NEUTROPENIA; OPEN STUDY; PERIPHERAL EDEMA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; REFRACTORY MULTIPLE MYELOMA; RHINOPHARYNGITIS; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE; TREATMENT WITHDRAWAL; TUMOR CELL; UPPER RESPIRATORY TRACT INFECTION; VOMITING; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; DISEASE FREE SURVIVAL; DRUG RESISTANCE; MIDDLE AGED; MORTALITY; RECURRENT DISEASE;

AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DEXAMETHASONE; DISEASE-FREE SURVIVAL; DRUG RESISTANCE, NEOPLASM; HUMANS; KAPLAN-MEIER ESTIMATE; MIDDLE AGED; MULTIPLE MYELOMA; RECURRENCE; THALIDOMIDE;

EID: 84990046018     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1607751     Document Type: Article

References (32)

1. Kumar SK, Rajkumar SV, Dispenzieri A, et al. Improved survival in multiple myeloma and the impact of novel therapies. Blood 2008; 111: 2516-20.
2. Kumar SK, Dispenzieri A, Lacy MQ, et al. Continued improvement in survival in multiple myeloma: changes in early mortality and outcomes in older patients. Leukemia 2014; 28: 1122-8.
3. Richardson PG, Hideshima T, Mitsiades C, Anderson KC. The emerging role of novel therapies for the treatment of relapsed myeloma. J Natl Compr Canc Netw 2007; 5: 149-62.
4. Moreau P, Touzeau C. Multiple myeloma: from front-line to relapsed therapies. Am Soc Clin Oncol Educ Book 2015; 35: e504-11.
5. Kumar S, Paiva B, Anderson KC, et al. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol 2016; 17(8): e328-46..
6. Martinez-Lopez J, Lahuerta JJ, Pepin F, et al. Prognostic value of deep sequencing method for minimal residual disease detection in multiple myeloma. Blood 2014; 123: 3073-9.
7. Lonial S, Anderson KC. Association of response endpoints with survival outcomes in multiple myeloma. Leukemia 2014; 28: 258-68.
8. 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.
9. 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.
10. Lokhorst HM, Plesner T, Laubach JP, et al. Targeting CD38 with daratumumab monotherapy in multiple myeloma. N Engl J Med 2015; 373: 1207-19.
11. McKeage K. Daratumumab: first global approval. Drugs 2016; 76: 275-81.
12. European Medicines Agency. EPAR summary for the public: Darzalex (daratumumab). London: European Medicines Agency, 2016 (http://www .ema .europa .eu/ docs/ en-GB/ document-library/ EPAR--- Summary-for-the-public/ human/ 004077/ WC500207298 .pdf).
13. Overdijk MB, Jansen JH, Nederend M, et al. The therapeutic CD38 monoclonal antibody daratumumab induces programmed cell death via Fcγ receptormediated cross-linking. J Immunol 2016; 197: 807-13.
14. 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: 311-21.
15. Lammerts van Bueren J, 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 56th Annual Meeting and Exposition of the American Society of Hematology, San Francisco, December 6-9, 2014. abstract.
16. Laubach JP, Richardson PG. CD38- targeted immunochemotherapy in refractory multiple myeloma: a new horizon. Clin Cancer Res 2015; 21: 2660-2.
17. 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 May 24 (Epub ahead of print).
18. Palumbo A, Chanan-Khan A, Weisel K, et al. Daratumumab, bortezomib and dexamethasone for multiple myeloma. N Engl J Med 2016; 375: 754-66.
19. Plesner T, Arkenau HT, Gimsing P, et al. Phase 1/2 study of daratumumab, lenalidomide, and dexamethasone for relapsed multiple myeloma. Blood 2016 August 16 (Epub ahead of print).
20. Durie BGM, Harousseau JL, Miguel JS, et al. International uniform response criteria for multiple myeloma. Leukemia 2006; 20: 1467-73.
21. 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.
22. Durie BG, Miguel JF, Blade J, Rajkumar SV. Clarification of the definition of complete response in multiple myeloma. Leukemia 2015; 29: 2416-7.
23. 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.
24. DeMets DL, Lan G. The alpha spending function approach to interim data analyses. Cancer Treat Res 1995; 75: 1-27.
25. Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983; 70: 659-63.
26. Chapuy CI, Nicholson RT, Aguad MD, et al. Resolving the daratumumab interference with blood compatibility testing. Transfusion 2015; 55: 1545-54.
27. Stewart AK, Rajkumar SV, Dimopoulos MA, et al. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med 2015; 372: 142-52.
28. Moreau P, Masszi T, Grzasko N, et al. Oral ixazomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med 2016; 374: 1621-34.
29. Zonder JA, Mohrbacher AF, Singhal S, et al. A phase 1, multicenter, open-label, dose escalation study of elotuzumab in patients with advanced multiple myeloma. Blood 2012; 120: 552-9.
30. Lonial S, Dimopoulos M, Palumbo A, et al. Elotuzumab therapy for relapsed or refractory multiple myeloma. N Engl J Med 2015; 373: 621-31.
31. Dimopoulos M, Spencer A, Attal M, et al. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med 2007; 357: 2123-32.
32. 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). Blood 2015; 126: 0508. abstract.