Daratumumab in multiple myeloma: experience of the multiple myeloma GIMEMA Lazio group
Daratumumab (DARA) is a human IgG-K monoclonal antibody (MoAb) targeting CD38 that is approved alone or in combination with bortezomib and dexamethasone or lenalidomide and dexamethasone for relapsed or refractory MM (RRMM) in patients previously exposed or double refractory to proteasome inhibitors...
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| Veröffentlicht in: | Annals of hematology 2021-04, Vol.100 (4), p.1059-1063 |
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| creator | Vozella, Federico Siniscalchi, A. Rizzo, M. Za, T. Antolino, G. Coppetelli, U. Piciocchi, A. Andriani, A. Annibali, O. De Rosa, L. Cimino, G. La Verde, G. De Stefano, V. Cantonetti, M. di Toritto, T. Caravita Petrucci, M. T. |
| description | Daratumumab (DARA) is a human IgG-K monoclonal antibody (MoAb) targeting CD38 that is approved alone or in combination with bortezomib and dexamethasone or lenalidomide and dexamethasone for relapsed or refractory MM (RRMM) in patients previously exposed or double refractory to proteasome inhibitors (PI) and immunomodulatory drugs (IMiDs). However, there are limited data on its clinical activity and tolerability in real-world patients. Therefore, in the present study, we aim to determine the efficacy and toxicity profile of daratumumab in a real-life setting. In this study, we report the experience of the multiple myeloma GIMEMA Lazio Group in 62 relapsed/refractory MM patients treated with daratumumab as monotherapy who had previously received at least two treatment lines including a PI and an IMiDs or had been double refractory. Patients received DARA 16 mg/kg intravenously weekly for 8 weeks, every 2 weeks for 16 weeks, and every 4 weeks until disease progression or unacceptable toxicity. The overall response rate to daratumumab was 46%. Median progression-free survival (PFS) and overall survival reached 2.7 and 22.4 months, respectively. DARA was generally well tolerated; however, 2 patients interrupted their therapy due to adverse events. Present real-life experience confirms that DARA monotherapy is an effective strategy for heavily pre-treated and refractory patients with multiple myeloma, with a favorable safety profile. |
| doi_str_mv | 10.1007/s00277-020-04374-y |
| format | Article |
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Caravita ; Petrucci, M. T.</creator><creatorcontrib>Vozella, Federico ; Siniscalchi, A. ; Rizzo, M. ; Za, T. ; Antolino, G. ; Coppetelli, U. ; Piciocchi, A. ; Andriani, A. ; Annibali, O. ; De Rosa, L. ; Cimino, G. ; La Verde, G. ; De Stefano, V. ; Cantonetti, M. ; di Toritto, T. Caravita ; Petrucci, M. T.</creatorcontrib><description>Daratumumab (DARA) is a human IgG-K monoclonal antibody (MoAb) targeting CD38 that is approved alone or in combination with bortezomib and dexamethasone or lenalidomide and dexamethasone for relapsed or refractory MM (RRMM) in patients previously exposed or double refractory to proteasome inhibitors (PI) and immunomodulatory drugs (IMiDs). However, there are limited data on its clinical activity and tolerability in real-world patients. Therefore, in the present study, we aim to determine the efficacy and toxicity profile of daratumumab in a real-life setting. In this study, we report the experience of the multiple myeloma GIMEMA Lazio Group in 62 relapsed/refractory MM patients treated with daratumumab as monotherapy who had previously received at least two treatment lines including a PI and an IMiDs or had been double refractory. Patients received DARA 16 mg/kg intravenously weekly for 8 weeks, every 2 weeks for 16 weeks, and every 4 weeks until disease progression or unacceptable toxicity. The overall response rate to daratumumab was 46%. Median progression-free survival (PFS) and overall survival reached 2.7 and 22.4 months, respectively. DARA was generally well tolerated; however, 2 patients interrupted their therapy due to adverse events. Present real-life experience confirms that DARA monotherapy is an effective strategy for heavily pre-treated and refractory patients with multiple myeloma, with a favorable safety profile.</description><identifier>ISSN: 0939-5555</identifier><identifier>EISSN: 1432-0584</identifier><identifier>DOI: 10.1007/s00277-020-04374-y</identifier><identifier>PMID: 33528611</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject><![CDATA[Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal - adverse effects ; Antibodies, Monoclonal - therapeutic use ; Antineoplastic Agents, Immunological - adverse effects ; Antineoplastic Agents, Immunological - therapeutic use ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Bortezomib - administration & dosage ; Clinical Trials, Phase II as Topic - statistics & numerical data ; Disease-Free Survival ; Drug Resistance, Neoplasm ; Female ; Hematology ; Hematopoietic Stem Cell Transplantation ; Humans ; Immunotherapy ; Kaplan-Meier Estimate ; Lenalidomide - administration & dosage ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Monoclonal antibodies ; Multicenter Studies as Topic - statistics & numerical data ; Multiple myeloma ; Multiple Myeloma - drug therapy ; Multiple Myeloma - mortality ; Multiple Myeloma - therapy ; Myeloma Proteins - analysis ; Oligopeptides - administration & dosage ; Oncology ; Original Article ; Progression-Free Survival ; Targeted cancer therapy ; Thalidomide - administration & dosage ; Thalidomide - analogs & derivatives]]></subject><ispartof>Annals of hematology, 2021-04, Vol.100 (4), p.1059-1063</ispartof><rights>The Author(s), under exclusive licence to Springer-Verlag GmbH, DE part of Springer Nature 2021</rights><rights>The Author(s), under exclusive licence to Springer-Verlag GmbH, DE part of Springer Nature 2021.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c424t-58a451ff2f200888d4fa60007993eebd5237d101502bb0a2a094fd9412ef6d7b3</citedby><cites>FETCH-LOGICAL-c424t-58a451ff2f200888d4fa60007993eebd5237d101502bb0a2a094fd9412ef6d7b3</cites><orcidid>0000-0001-9041-8483</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00277-020-04374-y$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00277-020-04374-y$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33528611$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vozella, Federico</creatorcontrib><creatorcontrib>Siniscalchi, A.</creatorcontrib><creatorcontrib>Rizzo, M.</creatorcontrib><creatorcontrib>Za, T.</creatorcontrib><creatorcontrib>Antolino, G.</creatorcontrib><creatorcontrib>Coppetelli, U.</creatorcontrib><creatorcontrib>Piciocchi, A.</creatorcontrib><creatorcontrib>Andriani, A.</creatorcontrib><creatorcontrib>Annibali, O.</creatorcontrib><creatorcontrib>De Rosa, L.</creatorcontrib><creatorcontrib>Cimino, G.</creatorcontrib><creatorcontrib>La Verde, G.</creatorcontrib><creatorcontrib>De Stefano, V.</creatorcontrib><creatorcontrib>Cantonetti, M.</creatorcontrib><creatorcontrib>di Toritto, T. Caravita</creatorcontrib><creatorcontrib>Petrucci, M. T.</creatorcontrib><title>Daratumumab in multiple myeloma: experience of the multiple myeloma GIMEMA Lazio group</title><title>Annals of hematology</title><addtitle>Ann Hematol</addtitle><addtitle>Ann Hematol</addtitle><description>Daratumumab (DARA) is a human IgG-K monoclonal antibody (MoAb) targeting CD38 that is approved alone or in combination with bortezomib and dexamethasone or lenalidomide and dexamethasone for relapsed or refractory MM (RRMM) in patients previously exposed or double refractory to proteasome inhibitors (PI) and immunomodulatory drugs (IMiDs). However, there are limited data on its clinical activity and tolerability in real-world patients. Therefore, in the present study, we aim to determine the efficacy and toxicity profile of daratumumab in a real-life setting. In this study, we report the experience of the multiple myeloma GIMEMA Lazio Group in 62 relapsed/refractory MM patients treated with daratumumab as monotherapy who had previously received at least two treatment lines including a PI and an IMiDs or had been double refractory. Patients received DARA 16 mg/kg intravenously weekly for 8 weeks, every 2 weeks for 16 weeks, and every 4 weeks until disease progression or unacceptable toxicity. The overall response rate to daratumumab was 46%. Median progression-free survival (PFS) and overall survival reached 2.7 and 22.4 months, respectively. DARA was generally well tolerated; however, 2 patients interrupted their therapy due to adverse events. Present real-life experience confirms that DARA monotherapy is an effective strategy for heavily pre-treated and refractory patients with multiple myeloma, with a favorable safety profile.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antibodies, Monoclonal - adverse effects</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Antineoplastic Agents, Immunological - adverse effects</subject><subject>Antineoplastic Agents, Immunological - therapeutic use</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Bortezomib - administration & dosage</subject><subject>Clinical Trials, Phase II as Topic - statistics & numerical data</subject><subject>Disease-Free Survival</subject><subject>Drug Resistance, Neoplasm</subject><subject>Female</subject><subject>Hematology</subject><subject>Hematopoietic Stem Cell Transplantation</subject><subject>Humans</subject><subject>Immunotherapy</subject><subject>Kaplan-Meier Estimate</subject><subject>Lenalidomide - administration & dosage</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Monoclonal antibodies</subject><subject>Multicenter Studies as Topic - statistics & numerical data</subject><subject>Multiple myeloma</subject><subject>Multiple Myeloma - drug therapy</subject><subject>Multiple Myeloma - mortality</subject><subject>Multiple Myeloma - therapy</subject><subject>Myeloma Proteins - analysis</subject><subject>Oligopeptides - administration & dosage</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Progression-Free Survival</subject><subject>Targeted cancer therapy</subject><subject>Thalidomide - administration & dosage</subject><subject>Thalidomide - analogs & derivatives</subject><issn>0939-5555</issn><issn>1432-0584</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9kMtOwzAQRS0EoqXwAyyQJdaB8SsPdlUppVIrNsDWchq7pMoLO5EIX48hBRZIzGYWc-aO5iB0TuCKAETXDoBGUQAUAuAs4kF_gMaEMxqAiPkhGkPCkkD4GqET53YAhMacHqMRY4LGISFj9HyrrGq7sitVivMKl13R5k2hcdnroi7VDdZvjba5rjYa1wa3L_oPgxfL9Xw9xSv1ntd4a-uuOUVHRhVOn-37BD3dzR9n98HqYbGcTVfBhlPeBiJWXBBjqKEAcRxn3KgQ_G9JwrROM0FZlBEgAmiagqIKEm6yhBOqTZhFKZugyyG3sfVrp10rd3VnK39SUgGEhQlj3FN0oDa2ds5qIxubl8r2koD8VCkHldKrlF8qZe-XLvbRXVrq7Gfl250H2AA4P6q22v7e_if2A1UHfnU</recordid><startdate>20210401</startdate><enddate>20210401</enddate><creator>Vozella, Federico</creator><creator>Siniscalchi, A.</creator><creator>Rizzo, M.</creator><creator>Za, T.</creator><creator>Antolino, G.</creator><creator>Coppetelli, U.</creator><creator>Piciocchi, A.</creator><creator>Andriani, A.</creator><creator>Annibali, O.</creator><creator>De Rosa, L.</creator><creator>Cimino, G.</creator><creator>La Verde, G.</creator><creator>De Stefano, V.</creator><creator>Cantonetti, M.</creator><creator>di Toritto, T. 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Caravita</au><au>Petrucci, M. T.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Daratumumab in multiple myeloma: experience of the multiple myeloma GIMEMA Lazio group</atitle><jtitle>Annals of hematology</jtitle><stitle>Ann Hematol</stitle><addtitle>Ann Hematol</addtitle><date>2021-04-01</date><risdate>2021</risdate><volume>100</volume><issue>4</issue><spage>1059</spage><epage>1063</epage><pages>1059-1063</pages><issn>0939-5555</issn><eissn>1432-0584</eissn><abstract>Daratumumab (DARA) is a human IgG-K monoclonal antibody (MoAb) targeting CD38 that is approved alone or in combination with bortezomib and dexamethasone or lenalidomide and dexamethasone for relapsed or refractory MM (RRMM) in patients previously exposed or double refractory to proteasome inhibitors (PI) and immunomodulatory drugs (IMiDs). However, there are limited data on its clinical activity and tolerability in real-world patients. Therefore, in the present study, we aim to determine the efficacy and toxicity profile of daratumumab in a real-life setting. In this study, we report the experience of the multiple myeloma GIMEMA Lazio Group in 62 relapsed/refractory MM patients treated with daratumumab as monotherapy who had previously received at least two treatment lines including a PI and an IMiDs or had been double refractory. Patients received DARA 16 mg/kg intravenously weekly for 8 weeks, every 2 weeks for 16 weeks, and every 4 weeks until disease progression or unacceptable toxicity. The overall response rate to daratumumab was 46%. Median progression-free survival (PFS) and overall survival reached 2.7 and 22.4 months, respectively. DARA was generally well tolerated; however, 2 patients interrupted their therapy due to adverse events. Present real-life experience confirms that DARA monotherapy is an effective strategy for heavily pre-treated and refractory patients with multiple myeloma, with a favorable safety profile.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>33528611</pmid><doi>10.1007/s00277-020-04374-y</doi><tpages>5</tpages><orcidid>https://orcid.org/0000-0001-9041-8483</orcidid></addata></record> |
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| subjects | Adult Aged Aged, 80 and over Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal - therapeutic use Antineoplastic Agents, Immunological - adverse effects Antineoplastic Agents, Immunological - therapeutic use Antineoplastic Combined Chemotherapy Protocols - therapeutic use Bortezomib - administration & dosage Clinical Trials, Phase II as Topic - statistics & numerical data Disease-Free Survival Drug Resistance, Neoplasm Female Hematology Hematopoietic Stem Cell Transplantation Humans Immunotherapy Kaplan-Meier Estimate Lenalidomide - administration & dosage Male Medicine Medicine & Public Health Middle Aged Monoclonal antibodies Multicenter Studies as Topic - statistics & numerical data Multiple myeloma Multiple Myeloma - drug therapy Multiple Myeloma - mortality Multiple Myeloma - therapy Myeloma Proteins - analysis Oligopeptides - administration & dosage Oncology Original Article Progression-Free Survival Targeted cancer therapy Thalidomide - administration & dosage Thalidomide - analogs & derivatives |
| title | Daratumumab in multiple myeloma: experience of the multiple myeloma GIMEMA Lazio group |
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