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M. Mateos, J. Estell, W. Barreto, P. Corradini, C. Min, E. Medvedova, M. Qi, Jordan Schecter, H. Amin, X. Qin, W. Deraedt, T. Casneuf, Christopher Chiu, A. Sasser, A. Nooka (2016)
Efficacy of Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Relapsed or Refractory Myeloma Based on Prior Lines of Therapy: Updated Analysis of CastorBlood, 128
K. Anderson, D. Auclair, G. Kelloff, C. Sigman, H. Avet-Loiseau, A. Farrell, N. Gormley, Shaji Kumar, O. Landgren, N. Munshi, M. Cavo, F. Davies, A. Bacco, J. Dickey, S. Gutman, H. Higley, M. Hussein, M. Hussein, J. Jessup, I. Kirsch, R. Little, R. Loberg, Jens Lohr, Lata Mukundan, J. Omel, Trevor Pugh, G. Reaman, Michael Robbins, A. Sasser, N. Valente, E. Zamagni (2017)
The Role of Minimal Residual Disease Testing in Myeloma Treatment Selection and Drug Development: Current Value and Future ApplicationsClinical Cancer Research, 23
Shaji Kumar, B. Paiva, K. Anderson, B. Durie, O. Landgren, P. Moreau, N. Munshi, S. Lonial, J. Bladé, M. Mateos, M. Dimopoulos, E. Kastritis, M. Boccadoro, M. Boccadoro, R. Orlowski, H. Goldschmidt, A. Spencer, J. Hou, W. Chng, S. Usmani, E. Zamagni, K. Shimizu, S. Jagannath, H. Johnsen, E. Terpos, A. Reiman, R. Kyle, P. Sonneveld, P. Richardson, P. McCarthy, H. Ludwig, Wenming Chen, M. Cavo, J. Harousseau, S. Lentzsch, J. Hillengass, A. Palumbo, A. Órfão, S. Rajkumar, J. Miguel, H. Avet-Loiseau (2016)
International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma.The Lancet. Oncology, 17 8
S. Usmani, J. Diels, Tetsuro Ito, M. Mehra, I. Khan, A. Lam (2017)
Daratumumab monotherapy compared with historical control data in heavily pretreated and highly refractory patients with multiple myeloma: An adjusted treatment comparisonAmerican Journal of Hematology, 92
C. Chapuy, Rachel Nicholson, M. Aguad, B. Chapuy, J. Laubach, P. Richardson, P. Doshi, R. Kaufman (2015)
Resolving the daratumumab interference with blood compatibility testingTransfusion, 55
M. Weers, Y. Tai, M. Veer, J. Bakker, T. Vink, D. Jacobs, L. Oomen, M. Peipp, T. Valerius, J. Slootstra, T. Mutis, W. Bleeker, K. Anderson, H. Lokhorst, J. Winkel, P. Parren (2011)
Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological TumorsThe Journal of Immunology, 186
S. Lentzsch, A. Nooka, H. Quach, Cindy Lee, W. Barreto, P. Corradini, C. Min, E. Scott, A. Chanan-Khan, N. Horvath, M. Capra, M. Beksaç, R. Ovilla, J. Jo, Ho-Jin Shin, D. Soong, T. Casneuf, Christopher Chiu, X. Qin, H. Amin, P. Sonneveld, Jordan Schecter, K. Sasser, M. Qi, M. Mateos (2017)
Daratumumab, Bortezomib and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in RRMM Based on Prior Lines and Treatment Exposure: CASTORClinical Lymphoma, Myeloma & Leukemia, 17
A. Palumbo, A. Chanan-Khan, K. Weisel, A. Nooka, T. Masszi, M. Beksaç, I. Špička, V. Hungria, M. Munder, M. Mateos, T. Mark, M. Qi, Jordan Schecter, H. Amin, X. Qin, W. Deraedt, T. Ahmadi, A. Spencer, P. Sonneveld (2016)
Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma.The New England journal of medicine, 375 8
(2017)
Real-world results of daratumumab monotherapy in heavily pretreated relapsed/refractory multiple myeloma in Poland: a prospective observational study of the Polish myeloma group [abstract no. E1262
M. Overdijk, S. Verploegen, M. Bögels, M. Egmond, J. Bueren, T. Mutis, R. Groen, E. Breij, A. Martens, W. Bleeker, P. Parren (2015)
Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myelomamAbs, 7
S. Rajkumar, J. Harousseau (2016)
Next-generation multiple myeloma treatment: a pharmacoeconomic perspective.Blood, 128 24
P. Moreau, J. Miguel, P. Sonneveld, M. Mateos, E. Zamagni, H. Avet-Loiseau, R. Hájek, M. Dimopoulos, H. Ludwig, H. Einsele, S. Zweegman, T. Facon, M. Cavo, E. Terpos, H. Goldschmidt, M. Attal, C. Buske (2010)
Multiple myeloma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.Annals of oncology : official journal of the European Society for Medical Oncology, 28 suppl_4
(2017)
Darzalex (daratumumab) injection, for intravenous use: US prescribing information. 2016
S. Lonial, B. Durie, A. Palumbo, J. San-Miguel (2015)
Monoclonal antibodies in the treatment of multiple myeloma: current status and future perspectivesLeukemia, 30
P. Clemens, Xiaoyu Yan, H. Lokhorst, S. Lonial, N. Losic, I. Khan, R. Jansson, T. Ahmadi, K. Lantz, Honghui Zhou, T. Puchalski, X. Xu (2016)
Pharmacokinetics of Daratumumab Following Intravenous Infusion in Relapsed or Refractory Multiple Myeloma After Prior Proteasome Inhibitor and Immunomodulatory Drug TreatmentClinical Pharmacokinetics, 56
S. Usmani, B. Weiss, T. Plesner, N. Bahlis, A. Belch, S. Lonial, H. Lokhorst, P. Voorhees, P. Richardson, A. Chari, A. Sasser, A. Axel, Huaibao Feng, C. Uhlar, Jianping Wang, I. Khan, T. Ahmadi, H. Nahi (2015)
Clinical efficacy of daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma.Blood, 128 1
P. Sonneveld (2017)
Should minimal residual disease negativity not be the end point of myeloma therapy?Blood advances, 1 8
J. San-Miguel, M. Dimopoulos, S. Usmani, A. Belch, N. Bahlis, D. White, L. Benboubker, G. Cook, M. Leiba, J. Morton, P. Ho, Kihyun Kim, N. Takezako, J. Kaufman, H. Sutherland, M. Lalancette, H. Magen, S. Iida, Jin Kim, H. Prince, T. Cochrane, A. Oriol, A. Chari, K. Wu, T. Casneuf (2017)
Depth of Response and MRD with Daratumumab Plus Lenalidomide and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in RRMM: POLLUXClinical Lymphoma, Myeloma & Leukemia, 17
M. Dimopoulos, K. Weisel, J. Kaufman, P. Sonneveld, M. Rizzo, Yingxin Xu, K. Fahrbach, M. Gaudig, M. Slavcev, A. Lam (2017)
Efficacy and Safety of Daratumumab-Based Regimens in Patients with Relapsed/Refractory Multiple Myeloma – A Systematic Literature Review and Network Meta-analysisClinical Lymphoma, Myeloma & Leukemia, 17
I. Nijhof, R. Groen, W. Noort, B. Kessel, Regina Jong-Korlaar, J. Bakker, J. Bueren, P. Parren, H. Lokhorst, Niels Donk, A. Martens, T. Mutis (2014)
Preclinical Evidence for the Therapeutic Potential of CD38-Targeted Immuno-Chemotherapy in Multiple Myeloma Patients Refractory to Lenalidomide and BortezomibClinical Cancer Research, 21
A. Chanan-Khan, S. Lentzsch, H. Quach, N. Horvath, M. Capra, R. Ovilla, J. Jo, Ho-Jin Shin, M. Qi, W. Deraedt, Jordan Schecter, H. Amin, X. Qin, T. Casneuf, Christopher Chiu, A. Sasser, P. Sonneveld (2016)
Daratumumab, Bortezomib and Dexamethasone Versus Bortezomib and Dexamethasone Alone for Relapsed or Refractory Multiple Myeloma Based on Prior Treatment Exposure: Updated Efficacy Analysis of CastorBlood, 128
R. Hájek, T. Jelínek, V. Maisnar, L. Pour, I. Špička, J. Minařík, E. Gregora, P. Kessler, M. Sýkora, H. Franková, D. Adamová, M. Wróbel, P. Mikula, Jirí Jarkovský, Xenia Gatopoulou, Š. Veselá, J. Diels, H. Besson, L. Brožová, T. Ito (2016)
Comparative Effectiveness of Daratumumab Monotherapy Versus a Real-World Historical Control from the Czech Republic in Heavily Pretreated and Highly Refractory Multiple Myeloma PatientsBlood, 128
M. Overdijk, J. Jansen, Maaike Nederend, Jeroen Lammerts, Van Bueren, R. Groen, P. Parren, J. Leusen, P. Boross (2016)
The Therapeutic CD38 Monoclonal Antibody Daratumumab Induces Programmed Cell Death via Fcγ Receptor–Mediated Cross-LinkingThe Journal of Immunology, 197
M. Veer, M. Weers, B. Kessel, J. Bakker, S. Wittebol, P. Parren, H. Lokhorst, T. Mutis (2011)
Towards effective immunotherapy of myeloma: enhanced elimination of myeloma cells by combination of lenalidomide with the human CD38 monoclonal antibody daratumumabHaematologica, 96
S. Usmani, M. Dimopoulos, A. Belch, D. White, L. Benboubker, G. Cook, M. Leiba, J. Morton, P. Ho, Kihyun Kim, N. Takezako, N. Khokhar, Mary Guckert, K. Wu, X. Qin, T. Casneuf, Christopher Chiu, A. Sasser, J. San-Miguel (2016)
Efficacy of Daratumumab, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients with 1 to 3 Prior Lines of Therapy: Updated Analysis of PolluxBlood, 128
K. Anderson (2017)
Should minimal residual disease negativity be the end point of myeloma therapy?Blood advances, 1 8
M. Dimopoulos, A. Oriol, H. Nahi, J. San-Miguel, N. Bahlis, S. Usmani, N. Rabin, R. Orlowski, M. Komarnicki, Kenshi Suzuki, T. Plesner, S. Yoon, D. Yehuda, P. Richardson, H. Goldschmidt, D. Reece, S. Lisby, N. Khokhar, L. O’Rourke, Christopher Chiu, X. Qin, Mary Guckert, T. Ahmadi, P. Moreau (2016)
Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma.The New England journal of medicine, 375 14
C. Beurden-Tan, M. Franken, H. Blommestein, C. Groot, P. Sonneveld (2017)
Systematic Literature Review and Network Meta-Analysis of Treatment Outcomes in Relapsed and/or Refractory Multiple Myeloma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 35 12
(2017)
Efficacy by cytogenetic risk status for daratumumab in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone in relapsed or refractory multiple myeloma [abstract no. S101
SK Kumar (2012)
149Leukemia, 26
Shaji Kumar, B. Durie, Zhuo Su, J. Diels, B. Hutton, A. Lam, Ito Tetsuro (2016)
Adjusted Comparisons Suggest Daratumumab Is Associated with Prolonged Survival Compared with Standard of Care Therapies in Patients with Heavily Pre-Treated and Highly Refractory Multiple MyelomaBlood, 128
Nimer Alsaid, A. McBride, A. Agarwal, Abdulaali Mutairi, F. Anwer, I. Abraham (2017)
Cost effectiveness of carfilzomib (CAR), ixazomib (IXA), elotuzumab (ELO), or daratumumab (DAR) with lenalidomide and dexamethasone (LEN+DEX) vs LEN+DEX in relapsed/refractory multiple myeloma (R/R MM).Journal of Clinical Oncology, 35
I. Nijhof, I. Nijhof, T. Casneuf, J. Velzen, B. Kessel, A. Axel, K. Syed, R. Groen, M. Duin, P. Sonneveld, M. Minnema, S. Zweegman, Christopher Chiu, A. Bloem, T. Mutis, H. Lokhorst, H. Lokhorst, A. Sasser, N. Donk (2016)
CD38 expression and complement inhibitors affect response and resistance to daratumumab therapy in myeloma.Blood, 128 7
S. Kumar, J. Lee, J. Lahuerta, G. Morgan, P. Richardson, J. Crowley, J. Haessler, J. Feather, A. Hoering, P. Moreau, X. Leleu, C. Hulin, S. Klein, P. Sonneveld, D. Siegel, J. Bladeé, H. Goldschmidt, S. Jagannath, J. Miguel, R. Orlowski, A. Palumbo, O. Sezer, S. Rajkumar (2012)
Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: A multicenter international myeloma working group studyLeukemia, 26
Shaji Kumar, N. Callander, M. Alsina, D. Atanackovic, J. Biermann, J. Chandler, C. Costello, M. Faiman, H. Fung, C. Gasparetto, K. Godby, C. Hofmeister, L. Holmberg, S. Holstein, C. Huff, A. Kassim, M. Liedtke, T. Martin, J. Omel, N. Raje, F. Reu, S. Singhal, G. Somlo, K. Stockerl-Goldstein, S. Treon, D. Weber, J. Yahalom, Dorothy Shead, Rashmi Kumar (2017)
Multiple Myeloma, Version 3.2017, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN, 15 2
M. Mateos, A. Spencer, A. Nooka, L. Pour, K. Weisel, M. Cavo, J. Laubach, G. Cook, S. Iida, L. Benboubker, S. Usmani, S. Yoon, N. Bahlis, Christopher Chiu, Jordan Schecter, K. Wu, X. Qin, D. Soong, M. Dimopoulos (2017)
Safety and efficacy of daratumumab-based regimens in elderly (≥75 y) patients (Pts) with relapsed or refractory multiple myeloma (RRMM): Subgroup analysis of POLLUX and CASTOR.Journal of Clinical Oncology, 35
T. Plesner, H. Arkenau, P. Gimsing, J. Krejcik, C. Lemech, M. Minnema, U. Lassen, J. Laubach, A. Palumbo, S. Lisby, L. Basse, Jianping Wang, A. Sasser, Mary Guckert, C. Boer, N. Khokhar, H. Yeh, P. Clemens, T. Ahmadi, H. Lokhorst, P. Richardson (2016)
Phase 1/2 study of daratumumab, lenalidomide, and dexamethasone for relapsed multiple myeloma.Blood, 128 14
T. Jelínek, V. Maisnar, L. Pour, I. Špička, J. Minařík, E. Gregora, P. Kessler, M. Sýkora, H. Franková, D. Adamová, M. Wróbel, P. Mikula, Jirí Jarkovský, J. Diels, Xenia Gatopoulou, Š. Veselá, H. Besson, L. Brožová, Tetsuro Ito, R. Hájek (2018)
Adjusted comparison of daratumumab monotherapy versus real-world historical control data from the Czech Republic in heavily pretreated and highly refractory multiple myeloma patientsCurrent Medical Research and Opinion, 34
P. Moreau, J. Kaufman, H. Sutherland, M. Lalancette, H. Magen, S. Iida, Jin Kim, M. Prince, T. Cochrane, N. Khokhar, Mary Guckert, X. Qin, A. Oriol (2016)
Efficacy of Daratumumab, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone Alone for Relapsed or Refractory Multiple Myeloma Among Patients with 1 to 3 Prior Lines of Therapy Based on Previous Treatment Exposure: Updated Analysis of PolluxBlood, 128
J. Krejcik, J. Krejcik, T. Casneuf, I. Nijhof, Bie Verbist, Jaime Bald, T. Plesner, K. Syed, K. Liu, N. Donk, B. Weiss, T. Ahmadi, H. Lokhorst, T. Mutis, A. Sasser (2016)
Daratumumab depletes CD38+ immune regulatory cells, promotes T-cell expansion, and skews T-cell repertoire in multiple myeloma.Blood, 128 3
S. Usmani, T. Ahmadi, Y. Ng, A. Lam, A. Desai, R. Potluri, M. Mehra (2016)
Analysis of Real-World Data on Overall Survival in Multiple Myeloma Patients With ≥3 Prior Lines of Therapy Including a Proteasome Inhibitor (PI) and an Immunomodulatory Drug (IMiD), or Double Refractory to a PI and an IMiD.The oncologist, 21 11
J. Harousseau, M. Attal (2017)
How I treat first relapse of myeloma.Blood, 130 8
A. Spencer, T. Mark, I. Špička, T. Masszi, B. Lauri, M. Levin, A. Bosi, V. Hungria, M. Cavo, Je-Jung Lee, D. Soong, T. Casneuf, Christopher Chiu, X. Qin, W. Deraedt, M. Qi, K. Sasser, Jordan Schecter, K. Weisel (2017)
Depth of Response and MRD with Daratumumab Plus Bortezomib and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in RRMM: CASTORClinical Lymphoma, Myeloma & Leukemia, 17
C. Botta, D. Ciliberto, M. Rossi, N. Staropoli, Maria Cucè, T. Galeano, P. Tagliaferri, P. Tassone (2017)
Network meta-analysis of randomized trials in multiple myeloma: efficacy and safety in relapsed/refractory patients.Blood advances, 1 7
H. Lokhorst, T. Plesner, J. Laubach, H. Nahi, P. Gimsing, M. Hansson, M. Minnema, U. Lassen, U. Lassen, J. Krejcik, A. Palumbo, N. Donk, T. Ahmadi, I. Khan, C. Uhlar, Jianping Wang, A. Sasser, N. Losic, S. Lisby, L. Basse, N. Brun, P. Richardson (2015)
Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma.The New England journal of medicine, 373 13
S. Lentzsch, K. Weisel, M. Mateos, V. Hungria, M. Munder, A. Nooka, T. Mark, H. Quach, Emma Scott, Je-Jung Lee, Pieter Sonneveld, T. Casneuf, Christopher Chiu, X. Qin, H. Amin, P. Thiyagarajah, Jordan Schecter, M. Qi, Andrew Spencer (2017)
DARATUMUMAB, BORTEZOMIB AND DEXAMETHASONE (DVD) VS BORTEZOMIB AND DEXAMETHASONE (VD) IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM): EFFICACY AND SAFETY UPDATE (CASTOR)Hematological Oncology, 35
S. Lonial, B. Weiss, S. Usmani, S. Singhal, A. Chari, N. Bahlis, A. Belch, A. Krishnan, R. Vescio, M. Mateos, A. Mazumder, R. Orlowski, H. Sutherland, J. Bladé, E. Scott, A. Oriol, J. Berdeja, M. Gharibo, D. Stevens, R. LeBlanc, M. Sebag, N. Callander, A. Jakubowiak, D. White, J. Rubia, P. Richardson, S. Lisby, Huaibao Feng, C. Uhlar, I. Khan, T. Ahmadi, P. Voorhees (2016)
Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trialThe Lancet, 387
M. Dimopoulos, A. Belch, D. White, L. Benboubker, G. Cook, M. Leiba, J. Morton, P. Ho, Kihyun Kim, N. Takezako, J. San-Miguel, P. Moreau, J. Kaufman, H. Sutherland, M. Lalancette, H. Magen, S. Iida, Jin Kim, H. Prince, T. Cochrane, A. Oriol, A. Chari, L. O’Rourke, K. Wu, T. Casneuf, Christopher Chiu, D. Soong, X. Qin, K. Sasser, N. Khokhar (2017)
Daratumumab, Lenalidomide and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in RRMM Based on Prior Lines and Treatment Exposure: POLLUXClinical Lymphoma, Myeloma & Leukemia, 17
Intravenous daratumumab (DARZALEX®) is a first-in-class human IgG1κ monoclonal antibody against CD38 available for use in patients with relapsed and/or refractory multiple myeloma. In phase I/II and II trials and a pooled analysis of these studies, daratumumab monotherapy induced an overall response (partial response or better) in approximately one-third of patients; responses were rapid, deep and durable. An overall survival (OS) benefit was seen with daratumumab monotherapy, including in patients with a minimal response or stable disease. In phase III trials, daratumumab in combination with either bortezomib plus dexamethasone or lenalidomide plus dexamethasone significantly prolonged progression-free survival and induced deep and durable responses compared with bortezomib plus dexamethasone or lenalidomide plus dexamethasone. An OS benefit with daratumumab triple combination therapy is yet to be demonstrated (as the OS data were not mature at the time of the last analysis). Daratumumab was generally well tolerated when used as monotherapy and had a generally manageable tolerability profile when used in combination therapy. Infusion-related reactions (IRRs) were the most common adverse events; these were predominantly grade 1 or 2 and mostly occurred during the first infusion. The most common grade 3–4 adverse events associated with daratumumab triple combination therapy were thrombocytopenia, neutropenia and anaemia. Although final OS data are awaited, current evidence indicates that daratumumab is a valuable addition to the treatment options currently available for patients with relapsed or refractory multiple myeloma.
Drugs – Springer Journals
Published: Nov 10, 2017
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