Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Chinese Patients with Relapsed or Refractory Multiple Myeloma: Phase 3 LEPUS (MMY3009) Study
Daratumumab plus bortezomib/dexamethasone (D-Vd) significantly improved outcomes versus Vd in patients with relapsed or refractory multiple myeloma (RRMM) in the phase 3 CASTOR study. We report the results of a prespecified interim analysis of the phase 3 LEPUS study of D-Vd versus Vd in Chinese pat...
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| Veröffentlicht in: | Clinical lymphoma, myeloma and leukemia myeloma and leukemia, 2021-09, Vol.21 (9), p.e699-e709 |
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| creator | Lu, Jin Fu, Weijun Li, Wei Hu, Jianda An, Gang Wang, Yafei Fu, Chengcheng Chen, Lijuan Jin, Jie Cen, Xinan Ge, Zheng Cai, Zhen Niu, Ting Qi, Ming Sun, Steven Gai, Xue Liu, Weiping Liu, Wenyu Yang, Xue Huang, Xiaojun |
| description | Daratumumab plus bortezomib/dexamethasone (D-Vd) significantly improved outcomes versus Vd in patients with relapsed or refractory multiple myeloma (RRMM) in the phase 3 CASTOR study. We report the results of a prespecified interim analysis of the phase 3 LEPUS study of D-Vd versus Vd in Chinese patients with RRMM.
Chinese patients with ≥ 1 prior line of therapy were randomized 2:1 to receive 8 cycles (21 days/cycle) of bortezomib (1.3 mg/m2 subcutaneously) and dexamethasone (20 mg orally/intravenously) ± daratumumab (16 mg/kg intravenously). The primary endpoint was progression-free survival (PFS).
A total of 211 patients were randomized (D-Vd, 141; Vd, 70). After an 8.2-month median follow-up, D-Vd significantly prolonged PFS versus Vd (median, not reached vs. 6.3 months; hazard ratio, 0.28; 95% confidence interval, 0.17-0.47; P < .00001) and significantly improved the rates of overall response (83% vs. 65%; P = .00527), ≥ very good partial response (65% vs. 33%; P = .00002), ≥ complete response (33% vs. 11%; P = .00079), and minimal residual disease negativity (10–5 sensitivity; 22% vs. 3%; P = .0002). The PFS benefit of D-Vd versus Vd was maintained across prespecified subgroups, including patients with prior bortezomib treatment and with high-risk cytogenetics. Thrombocytopenia (D-Vd, 51%; Vd, 37%), lymphopenia (44%; 29%), and lung infection (30%; 22%) were the 3 most common grade 3/4 treatment-emergent adverse events. Although patients in both treatment groups experienced higher rates of grade 3/4 lymphopenia and infections versus patients in CASTOR, the safety profile was generally consistent with that of CASTOR.
These data support the use of D-Vd in Chinese patients with RRMM.
Daratumumab plus bortezomib/dexamethasone (D-Vd) significantly improved outcomes versus Vd in patients with relapsed or refractory multiple myeloma (RRMM) in the global phase 3 CASTOR study. In this phase 3 LEPUS study, among Chinese patients with RRMM (D-Vd, 141 patients; Vd, 70 patients), D-Vd demonstrated significant efficacy benefits versus Vd, and a safety profile generally consistent with that reported in CASTOR. |
| doi_str_mv | 10.1016/j.clml.2021.04.012 |
| format | Article |
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Chinese patients with ≥ 1 prior line of therapy were randomized 2:1 to receive 8 cycles (21 days/cycle) of bortezomib (1.3 mg/m2 subcutaneously) and dexamethasone (20 mg orally/intravenously) ± daratumumab (16 mg/kg intravenously). The primary endpoint was progression-free survival (PFS).
A total of 211 patients were randomized (D-Vd, 141; Vd, 70). After an 8.2-month median follow-up, D-Vd significantly prolonged PFS versus Vd (median, not reached vs. 6.3 months; hazard ratio, 0.28; 95% confidence interval, 0.17-0.47; P < .00001) and significantly improved the rates of overall response (83% vs. 65%; P = .00527), ≥ very good partial response (65% vs. 33%; P = .00002), ≥ complete response (33% vs. 11%; P = .00079), and minimal residual disease negativity (10–5 sensitivity; 22% vs. 3%; P = .0002). The PFS benefit of D-Vd versus Vd was maintained across prespecified subgroups, including patients with prior bortezomib treatment and with high-risk cytogenetics. Thrombocytopenia (D-Vd, 51%; Vd, 37%), lymphopenia (44%; 29%), and lung infection (30%; 22%) were the 3 most common grade 3/4 treatment-emergent adverse events. Although patients in both treatment groups experienced higher rates of grade 3/4 lymphopenia and infections versus patients in CASTOR, the safety profile was generally consistent with that of CASTOR.
These data support the use of D-Vd in Chinese patients with RRMM.
Daratumumab plus bortezomib/dexamethasone (D-Vd) significantly improved outcomes versus Vd in patients with relapsed or refractory multiple myeloma (RRMM) in the global phase 3 CASTOR study. In this phase 3 LEPUS study, among Chinese patients with RRMM (D-Vd, 141 patients; Vd, 70 patients), D-Vd demonstrated significant efficacy benefits versus Vd, and a safety profile generally consistent with that reported in CASTOR.</description><identifier>ISSN: 2152-2650</identifier><identifier>EISSN: 2152-2669</identifier><identifier>DOI: 10.1016/j.clml.2021.04.012</identifier><identifier>PMID: 34108127</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Aged ; Antibodies, Monoclonal - pharmacology ; Antibodies, Monoclonal - therapeutic use ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Asian ; Bortezomib - pharmacology ; Bortezomib - therapeutic use ; CD38 ; China ; Dexamethasone - pharmacology ; Dexamethasone - therapeutic use ; Efficacy ; Female ; Humans ; Male ; Middle Aged ; Monoclonal antibody ; Multiple Myeloma - drug therapy ; Neoplasm Recurrence, Local ; Safety</subject><ispartof>Clinical lymphoma, myeloma and leukemia, 2021-09, Vol.21 (9), p.e699-e709</ispartof><rights>2021 Janssen Research & Development, LLC</rights><rights>Copyright © 2021 Janssen Research & Development, LLC. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c400t-7f4c94a9ef923602550a5388b2fd90d0bfdb3dc250398f423f633c0d55632b8e3</citedby><cites>FETCH-LOGICAL-c400t-7f4c94a9ef923602550a5388b2fd90d0bfdb3dc250398f423f633c0d55632b8e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S2152265021001567$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34108127$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lu, Jin</creatorcontrib><creatorcontrib>Fu, Weijun</creatorcontrib><creatorcontrib>Li, Wei</creatorcontrib><creatorcontrib>Hu, Jianda</creatorcontrib><creatorcontrib>An, Gang</creatorcontrib><creatorcontrib>Wang, Yafei</creatorcontrib><creatorcontrib>Fu, Chengcheng</creatorcontrib><creatorcontrib>Chen, Lijuan</creatorcontrib><creatorcontrib>Jin, Jie</creatorcontrib><creatorcontrib>Cen, Xinan</creatorcontrib><creatorcontrib>Ge, Zheng</creatorcontrib><creatorcontrib>Cai, Zhen</creatorcontrib><creatorcontrib>Niu, Ting</creatorcontrib><creatorcontrib>Qi, Ming</creatorcontrib><creatorcontrib>Sun, Steven</creatorcontrib><creatorcontrib>Gai, Xue</creatorcontrib><creatorcontrib>Liu, Weiping</creatorcontrib><creatorcontrib>Liu, Wenyu</creatorcontrib><creatorcontrib>Yang, Xue</creatorcontrib><creatorcontrib>Huang, Xiaojun</creatorcontrib><title>Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Chinese Patients with Relapsed or Refractory Multiple Myeloma: Phase 3 LEPUS (MMY3009) Study</title><title>Clinical lymphoma, myeloma and leukemia</title><addtitle>Clin Lymphoma Myeloma Leuk</addtitle><description>Daratumumab plus bortezomib/dexamethasone (D-Vd) significantly improved outcomes versus Vd in patients with relapsed or refractory multiple myeloma (RRMM) in the phase 3 CASTOR study. We report the results of a prespecified interim analysis of the phase 3 LEPUS study of D-Vd versus Vd in Chinese patients with RRMM.
Chinese patients with ≥ 1 prior line of therapy were randomized 2:1 to receive 8 cycles (21 days/cycle) of bortezomib (1.3 mg/m2 subcutaneously) and dexamethasone (20 mg orally/intravenously) ± daratumumab (16 mg/kg intravenously). The primary endpoint was progression-free survival (PFS).
A total of 211 patients were randomized (D-Vd, 141; Vd, 70). After an 8.2-month median follow-up, D-Vd significantly prolonged PFS versus Vd (median, not reached vs. 6.3 months; hazard ratio, 0.28; 95% confidence interval, 0.17-0.47; P < .00001) and significantly improved the rates of overall response (83% vs. 65%; P = .00527), ≥ very good partial response (65% vs. 33%; P = .00002), ≥ complete response (33% vs. 11%; P = .00079), and minimal residual disease negativity (10–5 sensitivity; 22% vs. 3%; P = .0002). The PFS benefit of D-Vd versus Vd was maintained across prespecified subgroups, including patients with prior bortezomib treatment and with high-risk cytogenetics. Thrombocytopenia (D-Vd, 51%; Vd, 37%), lymphopenia (44%; 29%), and lung infection (30%; 22%) were the 3 most common grade 3/4 treatment-emergent adverse events. Although patients in both treatment groups experienced higher rates of grade 3/4 lymphopenia and infections versus patients in CASTOR, the safety profile was generally consistent with that of CASTOR.
These data support the use of D-Vd in Chinese patients with RRMM.
Daratumumab plus bortezomib/dexamethasone (D-Vd) significantly improved outcomes versus Vd in patients with relapsed or refractory multiple myeloma (RRMM) in the global phase 3 CASTOR study. In this phase 3 LEPUS study, among Chinese patients with RRMM (D-Vd, 141 patients; Vd, 70 patients), D-Vd demonstrated significant efficacy benefits versus Vd, and a safety profile generally consistent with that reported in CASTOR.</description><subject>Adult</subject><subject>Aged</subject><subject>Antibodies, Monoclonal - pharmacology</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Asian</subject><subject>Bortezomib - pharmacology</subject><subject>Bortezomib - therapeutic use</subject><subject>CD38</subject><subject>China</subject><subject>Dexamethasone - pharmacology</subject><subject>Dexamethasone - therapeutic use</subject><subject>Efficacy</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Monoclonal antibody</subject><subject>Multiple Myeloma - drug therapy</subject><subject>Neoplasm Recurrence, Local</subject><subject>Safety</subject><issn>2152-2650</issn><issn>2152-2669</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc1uEzEUhUeIipbCC7BAXhaJDNf2_CI2kJa2UiIiSpFYWR77WnE0Mw62BwgPxTPiKKVigVj5LL5zpOsvy55RyCnQ6tUmV_3Q5wwYzaHIgbIH2QmjJZuxqmof3ucSjrPHIWwAagDaPsqOeUGhoaw-yX6dSy_jNEyD7F6Sd85H_OkGm7IcNTnHH3LAuJbBjUg-ow9T-Av6B2NHMl_bEQOSlYwWxxjIdxvX5CP2chtQE-dTNl6q6PyOLKc-2m2PZLnD3g3yNVmlJSScLC5WtzfkbLn8wgHaF-QmTnr3JDsysg_49O49zW7fX3yaX80WHy6v528XM1UAxFltCtUWskXTMl4BK0uQJW-ajhndgobO6I5rxUrgbWMKxk3FuQJdlhVnXYP8NDs77G69-zphiGKwQWHfyxHdFAQrU7FpeV0nlB1Q5V0IHo3YejtIvxMUxN6T2Ii9J7H3JKAQyVMqPb_bn7oB9X3lj5gEvDkAmK78ZtGLoNJvKtTWo4pCO_u__d91saSm</recordid><startdate>202109</startdate><enddate>202109</enddate><creator>Lu, Jin</creator><creator>Fu, Weijun</creator><creator>Li, Wei</creator><creator>Hu, Jianda</creator><creator>An, Gang</creator><creator>Wang, Yafei</creator><creator>Fu, Chengcheng</creator><creator>Chen, Lijuan</creator><creator>Jin, Jie</creator><creator>Cen, Xinan</creator><creator>Ge, Zheng</creator><creator>Cai, Zhen</creator><creator>Niu, Ting</creator><creator>Qi, Ming</creator><creator>Sun, Steven</creator><creator>Gai, Xue</creator><creator>Liu, Weiping</creator><creator>Liu, Wenyu</creator><creator>Yang, Xue</creator><creator>Huang, Xiaojun</creator><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202109</creationdate><title>Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Chinese Patients with Relapsed or Refractory Multiple Myeloma: Phase 3 LEPUS (MMY3009) Study</title><author>Lu, Jin ; Fu, Weijun ; Li, Wei ; Hu, Jianda ; An, Gang ; Wang, Yafei ; Fu, Chengcheng ; Chen, Lijuan ; Jin, Jie ; Cen, Xinan ; Ge, Zheng ; Cai, Zhen ; Niu, Ting ; Qi, Ming ; Sun, Steven ; Gai, Xue ; Liu, Weiping ; Liu, Wenyu ; Yang, Xue ; Huang, Xiaojun</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c400t-7f4c94a9ef923602550a5388b2fd90d0bfdb3dc250398f423f633c0d55632b8e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antibodies, Monoclonal - pharmacology</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Asian</topic><topic>Bortezomib - pharmacology</topic><topic>Bortezomib - therapeutic use</topic><topic>CD38</topic><topic>China</topic><topic>Dexamethasone - pharmacology</topic><topic>Dexamethasone - therapeutic use</topic><topic>Efficacy</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Monoclonal antibody</topic><topic>Multiple Myeloma - drug therapy</topic><topic>Neoplasm Recurrence, Local</topic><topic>Safety</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lu, Jin</creatorcontrib><creatorcontrib>Fu, Weijun</creatorcontrib><creatorcontrib>Li, Wei</creatorcontrib><creatorcontrib>Hu, Jianda</creatorcontrib><creatorcontrib>An, Gang</creatorcontrib><creatorcontrib>Wang, Yafei</creatorcontrib><creatorcontrib>Fu, Chengcheng</creatorcontrib><creatorcontrib>Chen, Lijuan</creatorcontrib><creatorcontrib>Jin, Jie</creatorcontrib><creatorcontrib>Cen, Xinan</creatorcontrib><creatorcontrib>Ge, Zheng</creatorcontrib><creatorcontrib>Cai, Zhen</creatorcontrib><creatorcontrib>Niu, Ting</creatorcontrib><creatorcontrib>Qi, Ming</creatorcontrib><creatorcontrib>Sun, Steven</creatorcontrib><creatorcontrib>Gai, Xue</creatorcontrib><creatorcontrib>Liu, Weiping</creatorcontrib><creatorcontrib>Liu, Wenyu</creatorcontrib><creatorcontrib>Yang, Xue</creatorcontrib><creatorcontrib>Huang, Xiaojun</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical lymphoma, myeloma and leukemia</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lu, Jin</au><au>Fu, Weijun</au><au>Li, Wei</au><au>Hu, Jianda</au><au>An, Gang</au><au>Wang, Yafei</au><au>Fu, Chengcheng</au><au>Chen, Lijuan</au><au>Jin, Jie</au><au>Cen, Xinan</au><au>Ge, Zheng</au><au>Cai, Zhen</au><au>Niu, Ting</au><au>Qi, Ming</au><au>Sun, Steven</au><au>Gai, Xue</au><au>Liu, Weiping</au><au>Liu, Wenyu</au><au>Yang, Xue</au><au>Huang, Xiaojun</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Chinese Patients with Relapsed or Refractory Multiple Myeloma: Phase 3 LEPUS (MMY3009) Study</atitle><jtitle>Clinical lymphoma, myeloma and leukemia</jtitle><addtitle>Clin Lymphoma Myeloma Leuk</addtitle><date>2021-09</date><risdate>2021</risdate><volume>21</volume><issue>9</issue><spage>e699</spage><epage>e709</epage><pages>e699-e709</pages><issn>2152-2650</issn><eissn>2152-2669</eissn><abstract>Daratumumab plus bortezomib/dexamethasone (D-Vd) significantly improved outcomes versus Vd in patients with relapsed or refractory multiple myeloma (RRMM) in the phase 3 CASTOR study. We report the results of a prespecified interim analysis of the phase 3 LEPUS study of D-Vd versus Vd in Chinese patients with RRMM.
Chinese patients with ≥ 1 prior line of therapy were randomized 2:1 to receive 8 cycles (21 days/cycle) of bortezomib (1.3 mg/m2 subcutaneously) and dexamethasone (20 mg orally/intravenously) ± daratumumab (16 mg/kg intravenously). The primary endpoint was progression-free survival (PFS).
A total of 211 patients were randomized (D-Vd, 141; Vd, 70). After an 8.2-month median follow-up, D-Vd significantly prolonged PFS versus Vd (median, not reached vs. 6.3 months; hazard ratio, 0.28; 95% confidence interval, 0.17-0.47; P < .00001) and significantly improved the rates of overall response (83% vs. 65%; P = .00527), ≥ very good partial response (65% vs. 33%; P = .00002), ≥ complete response (33% vs. 11%; P = .00079), and minimal residual disease negativity (10–5 sensitivity; 22% vs. 3%; P = .0002). The PFS benefit of D-Vd versus Vd was maintained across prespecified subgroups, including patients with prior bortezomib treatment and with high-risk cytogenetics. Thrombocytopenia (D-Vd, 51%; Vd, 37%), lymphopenia (44%; 29%), and lung infection (30%; 22%) were the 3 most common grade 3/4 treatment-emergent adverse events. Although patients in both treatment groups experienced higher rates of grade 3/4 lymphopenia and infections versus patients in CASTOR, the safety profile was generally consistent with that of CASTOR.
These data support the use of D-Vd in Chinese patients with RRMM.
Daratumumab plus bortezomib/dexamethasone (D-Vd) significantly improved outcomes versus Vd in patients with relapsed or refractory multiple myeloma (RRMM) in the global phase 3 CASTOR study. In this phase 3 LEPUS study, among Chinese patients with RRMM (D-Vd, 141 patients; Vd, 70 patients), D-Vd demonstrated significant efficacy benefits versus Vd, and a safety profile generally consistent with that reported in CASTOR.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>34108127</pmid><doi>10.1016/j.clml.2021.04.012</doi><oa>free_for_read</oa></addata></record> |
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| ispartof | Clinical lymphoma, myeloma and leukemia, 2021-09, Vol.21 (9), p.e699-e709 |
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| subjects | Adult Aged Antibodies, Monoclonal - pharmacology Antibodies, Monoclonal - therapeutic use Antineoplastic Combined Chemotherapy Protocols - therapeutic use Asian Bortezomib - pharmacology Bortezomib - therapeutic use CD38 China Dexamethasone - pharmacology Dexamethasone - therapeutic use Efficacy Female Humans Male Middle Aged Monoclonal antibody Multiple Myeloma - drug therapy Neoplasm Recurrence, Local Safety |
| title | Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Chinese Patients with Relapsed or Refractory Multiple Myeloma: Phase 3 LEPUS (MMY3009) Study |
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