Lenalidomide in combination with dexamethasone at first relapse in comparison with its use as later salvage therapy in relapsed or refractory multiple myeloma
Identifieur interne : 002F96 ( Istex/Corpus ); précédent : 002F95; suivant : 002F97Lenalidomide in combination with dexamethasone at first relapse in comparison with its use as later salvage therapy in relapsed or refractory multiple myeloma
Auteurs : Edward A. Stadtmauer ; Donna M. Weber ; Ruben Niesvizky ; Andrew Belch ; Miles H. Prince ; Jesús F. San Miguel ; Thierry Facon ; Marta Olesnyckyj ; Zhinuan Yu ; Jerome B. Zeldis ; Robert D. Knight ; Meletios A. DimopoulosSource :
- European Journal of Haematology [ 0902-4441 ] ; 2009-06.
English descriptors
- KwdEn :
- Abramson cancer center, Adverse events, Authors journal compilation, Baseline, Baseline characteristics, Blackwell munksgaard lenalidomide, Blackwell munksgaard stadtmauer, Bortezomib, Celgene, Celgene corporation, Cell transplantation, Combination therapy, Complete response, Dexamethasone, Dexamethasone treatment, Disease progression, Disease response, Dose reduction, European group, Further analysis, Grant support, Hazard ratio, Independent committee, International uniform response criteria, Last evaluation, Lecture fees, Lenalidomide, Lenalidomide treatment, Median, Median duration, More therapies, Multiple myeloma, Multivariate analysis, Munksgaard, Myeloma, National cancer institute, Novel agents, Overall survival, Peripheral neuropathy, Preliminary analysis, Progression, Relapse, Response rates, Separate line, Stadtmauer, Subset analysis, Thalidomide, Thalidomide treatment, Therapies lenalidomide, Therapy, Thrombotic events, Toxicity.
- Teeft :
- Abramson cancer center, Adverse events, Authors journal compilation, Baseline, Baseline characteristics, Blackwell munksgaard lenalidomide, Blackwell munksgaard stadtmauer, Bortezomib, Celgene, Celgene corporation, Cell transplantation, Combination therapy, Complete response, Dexamethasone, Dexamethasone treatment, Disease progression, Disease response, Dose reduction, European group, Further analysis, Grant support, Hazard ratio, Independent committee, International uniform response criteria, Last evaluation, Lecture fees, Lenalidomide, Lenalidomide treatment, Median, Median duration, More therapies, Multiple myeloma, Multivariate analysis, Munksgaard, Myeloma, National cancer institute, Novel agents, Overall survival, Peripheral neuropathy, Preliminary analysis, Progression, Relapse, Response rates, Separate line, Stadtmauer, Subset analysis, Thalidomide, Thalidomide treatment, Therapies lenalidomide, Therapy, Thrombotic events, Toxicity.
Abstract
This subset analysis of data from two phase III studies in patients with relapsed or refractory multiple myeloma (MM) evaluated the benefit of initiating lenalidomide plus dexamethasone at first relapse. Multivariate analysis showed that fewer prior therapies, along with β2‐microglobulin (≤2.5 mg/L), predicted a better time to progression (TTP; study end‐point) with lenalidomide plus dexamethasone treatment. Patients with one prior therapy showed a significant improvement in benefit after first relapse compared with those who received two or more therapies. Patients with one prior therapy had significantly prolonged median TTP (17.1 vs. 10.6 months; P = 0.026) and progression‐free survival (14.1 vs. 9.5 months, P = 0.047) compared with patients treated in later lines. Overall response rates were higher (66.9% vs. 56.8%, P = 0.06), and the complete response plus very good partial response rate was significantly higher in first relapse (39.8% vs. 27.7%, P = 0.025). Importantly, overall survival was significantly prolonged for patients treated with lenalidomide plus dexamethasone with one prior therapy, compared with patients treated later in salvage (median of 42.0 vs. 35.8 months, P = 0.041), with no differences in toxicity, dose reductions, or discontinuations despite longer treatment. Therefore, lenalidomide plus dexamethasone is both effective and tolerable for second‐line MM therapy and the data suggest that the greatest benefit occurs with earlier use.
Url:
DOI: 10.1111/j.1600-0609.2009.01257.x
Links to Exploration step
ISTEX:FE44613D0B7B6665D5A5B0133E48AD8E3572089ELe document en format XML
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Stadtmauer</name><affiliation><mods:affiliation>Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA</mods:affiliation></affiliation></author><author><name sortKey="Weber, Donna M" sort="Weber, Donna M" uniqKey="Weber D" first="Donna M." last="Weber">Donna M. Weber</name><affiliation><mods:affiliation>M. D. Anderson Cancer Center, Houston, TX, USA</mods:affiliation></affiliation></author><author><name sortKey="Niesvizky, Ruben" sort="Niesvizky, Ruben" uniqKey="Niesvizky R" first="Ruben" last="Niesvizky">Ruben Niesvizky</name><affiliation><mods:affiliation>Weill Cornell Medical College, New York, NY, USA</mods:affiliation></affiliation></author><author><name sortKey="Belch, Andrew" sort="Belch, Andrew" uniqKey="Belch A" first="Andrew" last="Belch">Andrew Belch</name><affiliation><mods:affiliation>Cross Cancer Institute, Edmonton, Alberta, Canada</mods:affiliation></affiliation></author><author><name sortKey="Prince, Miles H" sort="Prince, Miles H" uniqKey="Prince M" first="Miles H." last="Prince">Miles H. Prince</name><affiliation><mods:affiliation>Peter MacCallum Cancer Institute Division of Haematology/Medical Oncology and University of Melbourne, Melbourne, Australia</mods:affiliation></affiliation></author><author><name sortKey="San Miguel, Jesus F" sort="San Miguel, Jesus F" uniqKey="San Miguel J" first="Jesús F." last="San Miguel">Jesús F. San Miguel</name><affiliation><mods:affiliation>Servicio de Hematología, Hospital Universitario de Salamanca, CIC, IBMCC (USAL‐CSIC), Salamanca, Spain</mods:affiliation></affiliation></author><author><name sortKey="Facon, Thierry" sort="Facon, Thierry" uniqKey="Facon T" first="Thierry" last="Facon">Thierry Facon</name><affiliation><mods:affiliation>Hôpital Claude Huriez, Lille, France</mods:affiliation></affiliation></author><author><name sortKey="Olesnyckyj, Marta" sort="Olesnyckyj, Marta" uniqKey="Olesnyckyj M" first="Marta" last="Olesnyckyj">Marta Olesnyckyj</name><affiliation><mods:affiliation>Celgene Corporation, Summit, NJ, USA</mods:affiliation></affiliation></author><author><name sortKey="Yu, Zhinuan" sort="Yu, Zhinuan" uniqKey="Yu Z" first="Zhinuan" last="Yu">Zhinuan Yu</name><affiliation><mods:affiliation>Celgene Corporation, Summit, NJ, USA</mods:affiliation></affiliation></author><author><name sortKey="Zeldis, Jerome B" sort="Zeldis, Jerome B" uniqKey="Zeldis J" first="Jerome B." last="Zeldis">Jerome B. Zeldis</name><affiliation><mods:affiliation>Celgene Corporation, Summit, NJ, USA</mods:affiliation></affiliation></author><author><name sortKey="Knight, Robert D" sort="Knight, Robert D" uniqKey="Knight R" first="Robert D." last="Knight">Robert D. Knight</name><affiliation><mods:affiliation>Celgene Corporation, Summit, NJ, USA</mods:affiliation></affiliation></author><author><name sortKey="Dimopoulos, Meletios A" sort="Dimopoulos, Meletios A" uniqKey="Dimopoulos M" first="Meletios A." last="Dimopoulos">Meletios A. Dimopoulos</name><affiliation><mods:affiliation>University of Athens School of Medicine, Athens, Greece</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">European Journal of Haematology</title><title level="j" type="alt">EUROPEAN JOURNAL OF HAEMATOLOGY</title><idno type="ISSN">0902-4441</idno><idno type="eISSN">1600-0609</idno><imprint><biblScope unit="vol">82</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="426">426</biblScope><biblScope unit="page" to="432">432</biblScope><biblScope unit="page-count">7</biblScope><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><date type="published" when="2009-06">2009-06</date></imprint><idno type="ISSN">0902-4441</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0902-4441</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Abramson cancer center</term><term>Adverse events</term><term>Authors journal compilation</term><term>Baseline</term><term>Baseline characteristics</term><term>Blackwell munksgaard lenalidomide</term><term>Blackwell munksgaard stadtmauer</term><term>Bortezomib</term><term>Celgene</term><term>Celgene corporation</term><term>Cell transplantation</term><term>Combination therapy</term><term>Complete response</term><term>Dexamethasone</term><term>Dexamethasone treatment</term><term>Disease progression</term><term>Disease response</term><term>Dose reduction</term><term>European group</term><term>Further analysis</term><term>Grant support</term><term>Hazard ratio</term><term>Independent committee</term><term>International uniform response criteria</term><term>Last evaluation</term><term>Lecture fees</term><term>Lenalidomide</term><term>Lenalidomide treatment</term><term>Median</term><term>Median duration</term><term>More therapies</term><term>Multiple myeloma</term><term>Multivariate analysis</term><term>Munksgaard</term><term>Myeloma</term><term>National cancer institute</term><term>Novel agents</term><term>Overall survival</term><term>Peripheral neuropathy</term><term>Preliminary analysis</term><term>Progression</term><term>Relapse</term><term>Response rates</term><term>Separate line</term><term>Stadtmauer</term><term>Subset analysis</term><term>Thalidomide</term><term>Thalidomide treatment</term><term>Therapies lenalidomide</term><term>Therapy</term><term>Thrombotic events</term><term>Toxicity</term></keywords><keywords scheme="Teeft" xml:lang="en"><term>Abramson cancer center</term><term>Adverse events</term><term>Authors journal compilation</term><term>Baseline</term><term>Baseline characteristics</term><term>Blackwell munksgaard lenalidomide</term><term>Blackwell munksgaard stadtmauer</term><term>Bortezomib</term><term>Celgene</term><term>Celgene corporation</term><term>Cell transplantation</term><term>Combination therapy</term><term>Complete response</term><term>Dexamethasone</term><term>Dexamethasone treatment</term><term>Disease progression</term><term>Disease response</term><term>Dose reduction</term><term>European group</term><term>Further analysis</term><term>Grant support</term><term>Hazard ratio</term><term>Independent committee</term><term>International uniform response criteria</term><term>Last evaluation</term><term>Lecture fees</term><term>Lenalidomide</term><term>Lenalidomide treatment</term><term>Median</term><term>Median duration</term><term>More therapies</term><term>Multiple myeloma</term><term>Multivariate analysis</term><term>Munksgaard</term><term>Myeloma</term><term>National cancer institute</term><term>Novel agents</term><term>Overall survival</term><term>Peripheral neuropathy</term><term>Preliminary analysis</term><term>Progression</term><term>Relapse</term><term>Response rates</term><term>Separate line</term><term>Stadtmauer</term><term>Subset analysis</term><term>Thalidomide</term><term>Thalidomide treatment</term><term>Therapies lenalidomide</term><term>Therapy</term><term>Thrombotic events</term><term>Toxicity</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">This subset analysis of data from two phase III studies in patients with relapsed or refractory multiple myeloma (MM) evaluated the benefit of initiating lenalidomide plus dexamethasone at first relapse. Multivariate analysis showed that fewer prior therapies, along with β2‐microglobulin (≤2.5 mg/L), predicted a better time to progression (TTP; study end‐point) with lenalidomide plus dexamethasone treatment. Patients with one prior therapy showed a significant improvement in benefit after first relapse compared with those who received two or more therapies. Patients with one prior therapy had significantly prolonged median TTP (17.1 vs. 10.6 months; P = 0.026) and progression‐free survival (14.1 vs. 9.5 months, P = 0.047) compared with patients treated in later lines. Overall response rates were higher (66.9% vs. 56.8%, P = 0.06), and the complete response plus very good partial response rate was significantly higher in first relapse (39.8% vs. 27.7%, P = 0.025). Importantly, overall survival was significantly prolonged for patients treated with lenalidomide plus dexamethasone with one prior therapy, compared with patients treated later in salvage (median of 42.0 vs. 35.8 months, P = 0.041), with no differences in toxicity, dose reductions, or discontinuations despite longer treatment. Therefore, lenalidomide plus dexamethasone is both effective and tolerable for second‐line MM therapy and the data suggest that the greatest benefit occurs with earlier use.</div></front></TEI><istex><corpusName>wiley</corpusName><keywords><teeft><json:string>lenalidomide</json:string><json:string>myeloma</json:string><json:string>relapse</json:string><json:string>multiple myeloma</json:string><json:string>thalidomide</json:string><json:string>celgene corporation</json:string><json:string>celgene</json:string><json:string>dexamethasone</json:string><json:string>toxicity</json:string><json:string>median</json:string><json:string>bortezomib</json:string><json:string>stadtmauer</json:string><json:string>authors journal compilation</json:string><json:string>munksgaard</json:string><json:string>baseline</json:string><json:string>cell transplantation</json:string><json:string>disease progression</json:string><json:string>therapy</json:string><json:string>overall survival</json:string><json:string>baseline characteristics</json:string><json:string>median duration</json:string><json:string>more therapies</json:string><json:string>lecture fees</json:string><json:string>blackwell munksgaard stadtmauer</json:string><json:string>complete response</json:string><json:string>grant support</json:string><json:string>dexamethasone treatment</json:string><json:string>response rates</json:string><json:string>progression</json:string><json:string>combination therapy</json:string><json:string>last evaluation</json:string><json:string>national cancer institute</json:string><json:string>independent committee</json:string><json:string>blackwell munksgaard lenalidomide</json:string><json:string>international uniform response criteria</json:string><json:string>multivariate analysis</json:string><json:string>preliminary analysis</json:string><json:string>further analysis</json:string><json:string>subset analysis</json:string><json:string>hazard ratio</json:string><json:string>european group</json:string><json:string>therapies lenalidomide</json:string><json:string>disease response</json:string><json:string>lenalidomide treatment</json:string><json:string>dose reduction</json:string><json:string>thrombotic events</json:string><json:string>peripheral neuropathy</json:string><json:string>adverse events</json:string><json:string>novel agents</json:string><json:string>thalidomide treatment</json:string><json:string>abramson cancer center</json:string><json:string>separate line</json:string></teeft></keywords><author><json:item><name>Edward A. Stadtmauer</name><affiliations><json:string>Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA</json:string></affiliations></json:item><json:item><name>Donna M. Weber</name><affiliations><json:string>M. D. Anderson Cancer Center, Houston, TX, USA</json:string></affiliations></json:item><json:item><name>Ruben Niesvizky</name><affiliations><json:string>Weill Cornell Medical College, New York, NY, USA</json:string></affiliations></json:item><json:item><name>Andrew Belch</name><affiliations><json:string>Cross Cancer Institute, Edmonton, Alberta, Canada</json:string></affiliations></json:item><json:item><name>Miles H. Prince</name><affiliations><json:string>Peter MacCallum Cancer Institute Division of Haematology/Medical Oncology and University of Melbourne, Melbourne, Australia</json:string></affiliations></json:item><json:item><name>Jesús F. San Miguel</name><affiliations><json:string>Servicio de Hematología, Hospital Universitario de Salamanca, CIC, IBMCC (USAL‐CSIC), Salamanca, Spain</json:string></affiliations></json:item><json:item><name>Thierry Facon</name><affiliations><json:string>Hôpital Claude Huriez, Lille, France</json:string></affiliations></json:item><json:item><name>Marta Olesnyckyj</name><affiliations><json:string>Celgene Corporation, Summit, NJ, USA</json:string></affiliations></json:item><json:item><name>Zhinuan Yu</name><affiliations><json:string>Celgene Corporation, Summit, NJ, USA</json:string></affiliations></json:item><json:item><name>Jerome B. Zeldis</name><affiliations><json:string>Celgene Corporation, Summit, NJ, USA</json:string></affiliations></json:item><json:item><name>Robert D. Knight</name><affiliations><json:string>Celgene Corporation, Summit, NJ, USA</json:string></affiliations></json:item><json:item><name>Meletios A. Dimopoulos</name><affiliations><json:string>University of Athens School of Medicine, Athens, Greece</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>lenalidomide</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>multiple myeloma</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>relapse</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>time to progression</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>survival</value></json:item></subject><articleId><json:string>EJH1257</json:string></articleId><arkIstex>ark:/67375/WNG-K7RP9217-V</arkIstex><language><json:string>eng</json:string></language><originalGenre><json:string>article</json:string></originalGenre><abstract>This subset analysis of data from two phase III studies in patients with relapsed or refractory multiple myeloma (MM) evaluated the benefit of initiating lenalidomide plus dexamethasone at first relapse. Multivariate analysis showed that fewer prior therapies, along with β2‐microglobulin (≤2.5 mg/L), predicted a better time to progression (TTP; study end‐point) with lenalidomide plus dexamethasone treatment. Patients with one prior therapy showed a significant improvement in benefit after first relapse compared with those who received two or more therapies. Patients with one prior therapy had significantly prolonged median TTP (17.1 vs. 10.6 months; P = 0.026) and progression‐free survival (14.1 vs. 9.5 months, P = 0.047) compared with patients treated in later lines. Overall response rates were higher (66.9% vs. 56.8%, P = 0.06), and the complete response plus very good partial response rate was significantly higher in first relapse (39.8% vs. 27.7%, P = 0.025). Importantly, overall survival was significantly prolonged for patients treated with lenalidomide plus dexamethasone with one prior therapy, compared with patients treated later in salvage (median of 42.0 vs. 35.8 months, P = 0.041), with no differences in toxicity, dose reductions, or discontinuations despite longer treatment. Therefore, lenalidomide plus dexamethasone is both effective and tolerable for second‐line MM therapy and the data suggest that the greatest benefit occurs with earlier use.</abstract><qualityIndicators><score>8.146</score><pdfWordCount>3722</pdfWordCount><pdfCharCount>24465</pdfCharCount><pdfVersion>1.3</pdfVersion><pdfPageCount>7</pdfPageCount><pdfPageSize>595.276 x 782.362 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractWordCount>202</abstractWordCount><abstractCharCount>1480</abstractCharCount><keywordCount>5</keywordCount></qualityIndicators><title>Lenalidomide in combination with dexamethasone at first relapse in comparison with its use as later salvage therapy in relapsed or refractory multiple myeloma</title><pmid><json:string>19302559</json:string></pmid><genre><json:string>article</json:string></genre><host><title>European Journal of Haematology</title><language><json:string>unknown</json:string></language><doi><json:string>10.1111/(ISSN)1600-0609</json:string></doi><issn><json:string>0902-4441</json:string></issn><eissn><json:string>1600-0609</json:string></eissn><publisherId><json:string>EJH</json:string></publisherId><volume>82</volume><issue>6</issue><pages><first>426</first><last>432</last><total>7</total></pages><genre><json:string>journal</json:string></genre></host><namedEntities><unitex><date><json:string>2009</json:string><json:string>2008</json:string></date><geogName></geogName><orgName><json:string>Civic Center Blvd, Philadelphia</json:string><json:string>National Cancer Institute Common Toxicity Criteria</json:string><json:string>University of Athens School of Medicine</json:string><json:string>Anderson Cancer Center, Houston</json:string><json:string>Hospital Universitario</json:string><json:string>Cancer Institute Division</json:string><json:string>University of Pennsylvania School of Medicine</json:string><json:string>Abramson Cancer Center</json:string><json:string>University of Melbourne</json:string><json:string>Greece Abstract This</json:string><json:string>Celgene Corporation</json:string><json:string>University of Pennsylvania</json:string><json:string>Cross Cancer Institute, Edmonton, Alberta, Canada</json:string></orgName><orgName_funder></orgName_funder><orgName_provider></orgName_provider><persName><json:string>Incidence</json:string><json:string>Jerome B. Zeldis</json:string><json:string>Claude Huriez</json:string><json:string>Ruben Niesvizky</json:string><json:string>A. Dimopoulos</json:string><json:string>Thierry Facon</json:string><json:string>Andrew Belch</json:string><json:string>Peter MacCallum</json:string><json:string>Wang</json:string><json:string>Robert D. Knight</json:string><json:string>Edward A. Stadtmauer</json:string><json:string>Marta Olesnyckyj</json:string><json:string>Miles H. Prince</json:string><json:string>Donna M. 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Journal compilation © 2009 Blackwell Munksgaard</licence></availability><date type="published" when="2009-06"></date></publicationStmt><notesStmt><note type="content-type" subtype="article" source="article" scheme="https://content-type.data.istex.fr/ark:/67375/XTP-6N5SZHKN-D">article</note><note type="publication-type" subtype="journal" scheme="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</note></notesStmt><sourceDesc><biblStruct type="article"><analytic><title level="a" type="main">Lenalidomide in combination with dexamethasone at first relapse in comparison with its use as later salvage therapy in relapsed or refractory multiple myeloma</title><title level="a" type="short">Lenalidomide at first relapse in multiple myeloma</title><author xml:id="author-0000"><persName><forename type="first">Edward A.</forename><surname>Stadtmauer</surname></persName><affiliation>Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA<address><country key="US"></country></address></affiliation></author><author xml:id="author-0001"><persName><forename type="first">Donna M.</forename><surname>Weber</surname></persName><affiliation>M. D. Anderson Cancer Center, Houston, TX, USA<address><country key="US"></country></address></affiliation></author><author xml:id="author-0002"><persName><forename type="first">Ruben</forename><surname>Niesvizky</surname></persName><affiliation>Weill Cornell Medical College, New York, NY, USA<address><country key="US"></country></address></affiliation></author><author xml:id="author-0003"><persName><forename type="first">Andrew</forename><surname>Belch</surname></persName><affiliation>Cross Cancer Institute, Edmonton, Alberta, Canada<address><country key="CA"></country></address></affiliation></author><author xml:id="author-0004"><persName><forename type="first">Miles H.</forename><surname>Prince</surname></persName><affiliation>Peter MacCallum Cancer Institute Division of Haematology/Medical Oncology and University of Melbourne, Melbourne, Australia<address><country key="AU"></country></address></affiliation></author><author xml:id="author-0005"><persName><forename type="first">Jesús F.</forename><surname>San Miguel</surname></persName><affiliation>Servicio de Hematología, Hospital Universitario de Salamanca, CIC, IBMCC (USAL‐CSIC), Salamanca, Spain<address><country key="ES"></country></address></affiliation></author><author xml:id="author-0006"><persName><forename type="first">Thierry</forename><surname>Facon</surname></persName><affiliation>Hôpital Claude Huriez, Lille, France<address><country key="FR"></country></address></affiliation></author><author xml:id="author-0007"><persName><forename type="first">Marta</forename><surname>Olesnyckyj</surname></persName><affiliation>Celgene Corporation, Summit, NJ, USA<address><country key="US"></country></address></affiliation></author><author xml:id="author-0008"><persName><forename type="first">Zhinuan</forename><surname>Yu</surname></persName><affiliation>Celgene Corporation, Summit, NJ, USA<address><country key="US"></country></address></affiliation></author><author xml:id="author-0009"><persName><forename type="first">Jerome B.</forename><surname>Zeldis</surname></persName><affiliation>Celgene Corporation, Summit, NJ, USA<address><country key="US"></country></address></affiliation></author><author xml:id="author-0010"><persName><forename type="first">Robert D.</forename><surname>Knight</surname></persName><affiliation>Celgene Corporation, Summit, NJ, USA<address><country key="US"></country></address></affiliation></author><author xml:id="author-0011"><persName><forename type="first">Meletios A.</forename><surname>Dimopoulos</surname></persName><affiliation>University of Athens School of Medicine, Athens, Greece<address><country key="GR"></country></address></affiliation></author><idno type="istex">FE44613D0B7B6665D5A5B0133E48AD8E3572089E</idno><idno type="ark">ark:/67375/WNG-K7RP9217-V</idno><idno type="DOI">10.1111/j.1600-0609.2009.01257.x</idno><idno type="unit">EJH1257</idno><idno type="supplier">1257</idno><idno type="toTypesetVersion">file:EJH.EJH1257.pdf</idno></analytic><monogr><title level="j" type="main">European Journal of Haematology</title><title level="j" type="alt">EUROPEAN JOURNAL OF HAEMATOLOGY</title><idno type="pISSN">0902-4441</idno><idno type="eISSN">1600-0609</idno><idno type="book-DOI">10.1111/(ISSN)1600-0609</idno><idno type="book-part-DOI">10.1111/ejh.2009.82.issue-6</idno><idno type="product">EJH</idno><idno type="publisherDivision">ST</idno><imprint><biblScope unit="vol">82</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="426">426</biblScope><biblScope unit="page" to="432">432</biblScope><biblScope unit="page-count">7</biblScope><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><date type="published" when="2009-06"></date></imprint></monogr></biblStruct></sourceDesc></fileDesc><profileDesc><abstract xml:lang="en" style="main"><head>Abstract</head><p>This subset analysis of data from two phase III studies in patients with relapsed or refractory multiple myeloma (MM) evaluated the benefit of initiating lenalidomide plus dexamethasone at first relapse. Multivariate analysis showed that fewer prior therapies, along with β<hi rend="subscript">2</hi>‐microglobulin (≤2.5 mg/L), predicted a better time to progression (TTP; study end‐point) with lenalidomide plus dexamethasone treatment. Patients with one prior therapy showed a significant improvement in benefit after first relapse compared with those who received two or more therapies. Patients with one prior therapy had significantly prolonged median TTP (17.1 vs. 10.6 months; <hi rend="italic">P </hi>=<hi rend="italic"> </hi>0.026) and progression‐free survival (14.1 vs. 9.5 months, <hi rend="italic">P </hi>=<hi rend="italic"> </hi>0.047) compared with patients treated in later lines. Overall response rates were higher (66.9% vs. 56.8%, <hi rend="italic">P </hi>=<hi rend="italic"> </hi>0.06), and the complete response plus very good partial response rate was significantly higher in first relapse (39.8% vs. 27.7%, <hi rend="italic">P </hi>=<hi rend="italic"> </hi>0.025). Importantly, overall survival was significantly prolonged for patients treated with lenalidomide plus dexamethasone with one prior therapy, compared with patients treated later in salvage (median of 42.0 vs. 35.8 months, <hi rend="italic">P </hi>=<hi rend="italic"> </hi>0.041), with no differences in toxicity, dose reductions, or discontinuations despite longer treatment. Therefore, lenalidomide plus dexamethasone is both effective and tolerable for second‐line MM therapy and the data suggest that the greatest benefit occurs with earlier use.</p></abstract><textClass><keywords xml:lang="en"><term xml:id="k1">lenalidomide</term><term xml:id="k2">multiple myeloma</term><term xml:id="k3">relapse</term><term xml:id="k4">time to progression</term><term xml:id="k5">survival</term></keywords><keywords rend="tocHeading1"><term>Original Articles</term></keywords></textClass><langUsage><language ident="en"></language></langUsage></profileDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/document/FE44613D0B7B6665D5A5B0133E48AD8E3572089E/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Blackwell Publishing Ltd</publisherName><publisherLoc>Oxford, UK</publisherLoc></publisherInfo><doi origin="wiley" registered="yes">10.1111/(ISSN)1600-0609</doi><issn type="print">0902-4441</issn><issn type="electronic">1600-0609</issn><idGroup><id type="product" value="EJH"></id><id type="publisherDivision" value="ST"></id></idGroup><titleGroup><title type="main" sort="EUROPEAN JOURNAL OF HAEMATOLOGY">European Journal of Haematology</title></titleGroup></publicationMeta><publicationMeta level="part" position="06006"><doi origin="wiley">10.1111/ejh.2009.82.issue-6</doi><numberingGroup><numbering type="journalVolume" number="82">82</numbering><numbering type="journalIssue" number="6">6</numbering></numberingGroup><coverDate startDate="2009-06">June 2009</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="2" status="forIssue" accessType="open"><doi origin="wiley">10.1111/j.1600-0609.2009.01257.x</doi><idGroup><id type="unit" value="EJH1257"></id><id type="supplier" value="1257"></id></idGroup><countGroup><count type="pageTotal" number="7"></count></countGroup><titleGroup><title type="tocHeading1"><i>Original Articles</i></title></titleGroup><copyright>© 2009 The Authors. Journal compilation © 2009 Blackwell Munksgaard</copyright><eventGroup><event type="firstOnline" date="2009-03-19"></event><event type="publishedOnlineFinalForm" date="2009-04-21"></event><event type="xmlConverted" agent="Converter:BPG_TO_WML3G version:2.3.2 mode:FullText source:FullText result:FullText" date="2010-03-06"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.8.8" date="2014-01-21"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.1.7 mode:FullText,remove_FC" date="2014-10-16"></event></eventGroup><numberingGroup><numbering type="pageFirst" number="426">426</numbering><numbering type="pageLast" number="432">432</numbering></numberingGroup><correspondenceTo>Dr Edward A. Stadtmauer, Abramson Cancer Center, University of Pennsylvania School of Medicine, 16 Penn Tower, 34th and Civic Center Blvd, Philadelphia, PA 19104, USA. Tel: + 1 215 662 7910; Fax: +1 215 662 4064; e‐mail: <email>edward.stadtmauer@uphs.upenn.edu</email></correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:EJH.EJH1257.pdf"></link></linkGroup></publicationMeta><contentMeta><unparsedEditorialHistory>Accepted for publication 9 March 2009</unparsedEditorialHistory><countGroup><count type="figureTotal" number="3"></count><count type="tableTotal" number="4"></count></countGroup><titleGroup><title type="main">Lenalidomide in combination with dexamethasone at first relapse in comparison with its use as later salvage therapy in relapsed or refractory multiple myeloma</title><title type="shortAuthors">Stadtmauer <i>et al.</i></title><title type="short">Lenalidomide at first relapse in multiple myeloma</title></titleGroup><creators><creator creatorRole="author" xml:id="cr1" affiliationRef="#a1"><personName><givenNames>Edward A.</givenNames><familyName>Stadtmauer</familyName></personName></creator><creator creatorRole="author" xml:id="cr2" affiliationRef="#a2"><personName><givenNames>Donna M.</givenNames><familyName>Weber</familyName></personName></creator><creator creatorRole="author" xml:id="cr3" affiliationRef="#a3"><personName><givenNames>Ruben</givenNames><familyName>Niesvizky</familyName></personName></creator><creator creatorRole="author" xml:id="cr4" affiliationRef="#a4"><personName><givenNames>Andrew</givenNames><familyName>Belch</familyName></personName></creator><creator creatorRole="author" xml:id="cr5" affiliationRef="#a5"><personName><givenNames>Miles H.</givenNames><familyName>Prince</familyName></personName></creator><creator creatorRole="author" xml:id="cr6" affiliationRef="#a6"><personName><givenNames>Jesús F.</givenNames><familyName>San Miguel</familyName></personName></creator><creator creatorRole="author" xml:id="cr7" affiliationRef="#a7"><personName><givenNames>Thierry</givenNames><familyName>Facon</familyName></personName></creator><creator creatorRole="author" xml:id="cr8" affiliationRef="#a8"><personName><givenNames>Marta</givenNames><familyName>Olesnyckyj</familyName></personName></creator><creator creatorRole="author" xml:id="cr9" affiliationRef="#a8"><personName><givenNames>Zhinuan</givenNames><familyName>Yu</familyName></personName></creator><creator creatorRole="author" xml:id="cr10" affiliationRef="#a8"><personName><givenNames>Jerome B.</givenNames><familyName>Zeldis</familyName></personName></creator><creator creatorRole="author" xml:id="cr11" affiliationRef="#a8"><personName><givenNames>Robert D.</givenNames><familyName>Knight</familyName></personName></creator><creator creatorRole="author" xml:id="cr12" affiliationRef="#a9"><personName><givenNames>Meletios A.</givenNames><familyName>Dimopoulos</familyName></personName></creator></creators><affiliationGroup><affiliation xml:id="a1" countryCode="US"><unparsedAffiliation>Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA</unparsedAffiliation></affiliation><affiliation xml:id="a2" countryCode="US"><unparsedAffiliation>M. 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Multivariate analysis showed that fewer prior therapies, along with β<sub>2</sub>‐microglobulin (≤2.5 mg/L), predicted a better time to progression (TTP; study end‐point) with lenalidomide plus dexamethasone treatment. Patients with one prior therapy showed a significant improvement in benefit after first relapse compared with those who received two or more therapies. Patients with one prior therapy had significantly prolonged median TTP (17.1 vs. 10.6 months; <i>P </i>=<i> </i>0.026) and progression‐free survival (14.1 vs. 9.5 months, <i>P </i>=<i> </i>0.047) compared with patients treated in later lines. Overall response rates were higher (66.9% vs. 56.8%, <i>P </i>=<i> </i>0.06), and the complete response plus very good partial response rate was significantly higher in first relapse (39.8% vs. 27.7%, <i>P </i>=<i> </i>0.025). Importantly, overall survival was significantly prolonged for patients treated with lenalidomide plus dexamethasone with one prior therapy, compared with patients treated later in salvage (median of 42.0 vs. 35.8 months, <i>P </i>=<i> </i>0.041), with no differences in toxicity, dose reductions, or discontinuations despite longer treatment. Therefore, lenalidomide plus dexamethasone is both effective and tolerable for second‐line MM therapy and the data suggest that the greatest benefit occurs with earlier use.</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn1" numbered="no"><p>Re‐use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Lenalidomide in combination with dexamethasone at first relapse in comparison with its use as later salvage therapy in relapsed or refractory multiple myeloma</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Lenalidomide at first relapse in multiple myeloma</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Lenalidomide in combination with dexamethasone at first relapse in comparison with its use as later salvage therapy in relapsed or refractory multiple myeloma</title></titleInfo><name type="personal"><namePart type="given">Edward A.</namePart><namePart type="family">Stadtmauer</namePart><affiliation>Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Donna M.</namePart><namePart type="family">Weber</namePart><affiliation>M. 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Anderson Cancer Center, Houston, TX, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Ruben</namePart><namePart type="family">Niesvizky</namePart><affiliation>Weill Cornell Medical College, New York, NY, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Andrew</namePart><namePart type="family">Belch</namePart><affiliation>Cross Cancer Institute, Edmonton, Alberta, Canada</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Miles H.</namePart><namePart type="family">Prince</namePart><affiliation>Peter MacCallum Cancer Institute Division of Haematology/Medical Oncology and University of Melbourne, Melbourne, Australia</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jesús F.</namePart><namePart type="family">San Miguel</namePart><affiliation>Servicio de Hematología, Hospital Universitario de Salamanca, CIC, IBMCC (USAL‐CSIC), Salamanca, Spain</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Thierry</namePart><namePart type="family">Facon</namePart><affiliation>Hôpital Claude Huriez, Lille, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Marta</namePart><namePart type="family">Olesnyckyj</namePart><affiliation>Celgene Corporation, Summit, NJ, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Zhinuan</namePart><namePart type="family">Yu</namePart><affiliation>Celgene Corporation, Summit, NJ, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jerome B.</namePart><namePart type="family">Zeldis</namePart><affiliation>Celgene Corporation, Summit, NJ, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Robert D.</namePart><namePart type="family">Knight</namePart><affiliation>Celgene Corporation, Summit, NJ, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Meletios A.</namePart><namePart type="family">Dimopoulos</namePart><affiliation>University of Athens School of Medicine, Athens, Greece</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-6N5SZHKN-D">article</genre><originInfo><publisher>Blackwell Publishing Ltd</publisher><place><placeTerm type="text">Oxford, UK</placeTerm></place><dateIssued encoding="w3cdtf">2009-06</dateIssued><edition>Accepted for publication 9 March 2009</edition><copyrightDate encoding="w3cdtf">2009</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><extent unit="figures">3</extent><extent unit="tables">4</extent></physicalDescription><abstract lang="en">This subset analysis of data from two phase III studies in patients with relapsed or refractory multiple myeloma (MM) evaluated the benefit of initiating lenalidomide plus dexamethasone at first relapse. Multivariate analysis showed that fewer prior therapies, along with β2‐microglobulin (≤2.5 mg/L), predicted a better time to progression (TTP; study end‐point) with lenalidomide plus dexamethasone treatment. Patients with one prior therapy showed a significant improvement in benefit after first relapse compared with those who received two or more therapies. Patients with one prior therapy had significantly prolonged median TTP (17.1 vs. 10.6 months; P = 0.026) and progression‐free survival (14.1 vs. 9.5 months, P = 0.047) compared with patients treated in later lines. Overall response rates were higher (66.9% vs. 56.8%, P = 0.06), and the complete response plus very good partial response rate was significantly higher in first relapse (39.8% vs. 27.7%, P = 0.025). Importantly, overall survival was significantly prolonged for patients treated with lenalidomide plus dexamethasone with one prior therapy, compared with patients treated later in salvage (median of 42.0 vs. 35.8 months, P = 0.041), with no differences in toxicity, dose reductions, or discontinuations despite longer treatment. Therefore, lenalidomide plus dexamethasone is both effective and tolerable for second‐line MM therapy and the data suggest that the greatest benefit occurs with earlier use.</abstract><subject lang="en"><genre>keywords</genre><topic>lenalidomide</topic><topic>multiple myeloma</topic><topic>relapse</topic><topic>time to progression</topic><topic>survival</topic></subject><relatedItem type="host"><titleInfo><title>European Journal of Haematology</title></titleInfo><genre type="journal" authority="ISTEX" authorityURI="https://publication-type.data.istex.fr" valueURI="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</genre><identifier type="ISSN">0902-4441</identifier><identifier type="eISSN">1600-0609</identifier><identifier type="DOI">10.1111/(ISSN)1600-0609</identifier><identifier type="PublisherID">EJH</identifier><part><date>2009</date><detail type="volume"><caption>vol.</caption><number>82</number></detail><detail type="issue"><caption>no.</caption><number>6</number></detail><extent unit="pages"><start>426</start><end>432</end><total>7</total></extent></part></relatedItem><identifier type="istex">FE44613D0B7B6665D5A5B0133E48AD8E3572089E</identifier><identifier type="ark">ark:/67375/WNG-K7RP9217-V</identifier><identifier type="DOI">10.1111/j.1600-0609.2009.01257.x</identifier><identifier type="ArticleID">EJH1257</identifier><accessCondition type="use and reproduction" contentType="copyright">© 2009 The Authors. 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