Long-term follow-up on overall survival from the MM-009 and MM-010 phase III trials of lenalidomide plus dexamethasone in patients with relapsed or refractory multiple myeloma
Identifieur interne : 008238 ( Main/Exploration ); précédent : 008237; suivant : 008239Long-term follow-up on overall survival from the MM-009 and MM-010 phase III trials of lenalidomide plus dexamethasone in patients with relapsed or refractory multiple myeloma
Auteurs : M. A. Dimopoulos [Grèce] ; C. Chen [Canada] ; A. Spencer [Australie] ; R. Niesvizky [États-Unis] ; M. Attal [France] ; E. A. Stadtmauer [États-Unis] ; M. T. Petrucci [Italie] ; Z. Yu [États-Unis] ; M. Olesnyckyj [États-Unis] ; J. B. Zeldis [États-Unis] ; R. D. Knight [États-Unis] ; D. M. Weber [États-Unis]Source :
- Leukemia [ 0887-6924 ] ; 2009.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
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Abstract
We present a pooled update of two large, multicenter MM-009 and MM-010 placebo-controlled randomized phase III trials that included 704 patients and assessed lenalidomide plus dexamethasone versus dexamethasone plus placebo in patients with relapsed/refractory multiple myeloma (MM). Patients in both studies were randomized to receive 25 mg daily oral lenalidomide or identical placebo, plus 40 mg oral dexamethasone. In this pooled analysis, using data up to unblinding (June 2005 for MM-009 and August 2005 for MM-010), treatment with lenalidomide plus dexamethasone significantly improved overall response (60.6 vs 21.9%, P< 0.001), complete response rate (15.0 vs 2.0%, P<0.001), time to progression (median of 13.4 vs 4.6 months, P<0.001) and duration of response (median of 15.8 months vs 7 months, P< 0.001 ) compared with dexamethasone-placebo. At a median follow-up of 48 months for surviving patients, using data up to July 2008, a significant benefit in overall survival (median of 38.0 vs 31.6 months, P= 0.045) was retained despite 47.6% of patients who were randomized to dexamethasone-placebo receiving lenalidomide-based treatment after disease progression or study unblinding. Low β2-Microglobulin and low bone marrow plasmacytosis were associated with longer survival. In conclusion, these data confirm the significant response and survival benefit with lenalidomide and dexamethasone.
Affiliations:
- Australie, Canada, France, Grèce, Italie, États-Unis
- Attique (région), Latium, Midi-Pyrénées, Occitanie (région administrative), Victoria (État)
- Athènes, Melbourne, Rome, Toulouse
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Long-term follow-up on overall survival from the MM-009 and MM-010 phase III trials of lenalidomide plus dexamethasone in patients with relapsed or refractory multiple myeloma</title><author><name sortKey="Dimopoulos, M A" sort="Dimopoulos, M A" uniqKey="Dimopoulos M" first="M. A." last="Dimopoulos">M. A. Dimopoulos</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Department of Clinical Therapeutics, University of Athens School of Medicine</s1><s2>Athens</s2><s3>GRC</s3><sZ>1 aut.</sZ></inist:fA14><country>Grèce</country><placeName><settlement type="city">Athènes</settlement><region nuts="2" type="region">Attique (région)</region></placeName></affiliation></author><author><name sortKey="Chen, C" sort="Chen, C" uniqKey="Chen C" first="C." last="Chen">C. Chen</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Medical Oncology and Hematology, Princess Margaret Hospital</s1><s2>Toronto, Ontario</s2><s3>CAN</s3><sZ>2 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Toronto, Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Spencer, A" sort="Spencer, A" uniqKey="Spencer A" first="A." last="Spencer">A. Spencer</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Department of Clinical Haematology and Bone Marrow Transplantation, The Alfred Hospital</s1><s2>Melbourne</s2><s3>AUS</s3><sZ>3 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Niesvizky, R" sort="Niesvizky, R" uniqKey="Niesvizky R" first="R." last="Niesvizky">R. Niesvizky</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Department of Medicine, Weill Cornell Medical College</s1><s2>New York, NY</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>New York, NY</wicri:noRegion></affiliation></author><author><name sortKey="Attal, M" sort="Attal, M" uniqKey="Attal M" first="M." last="Attal">M. Attal</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Department of Hematology, C.H.U. Purpan</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>5 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Stadtmauer, E A" sort="Stadtmauer, E A" uniqKey="Stadtmauer E" first="E. A." last="Stadtmauer">E. A. Stadtmauer</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Abramson Cancer Center, University of Pennsylvania</s1><s2>Philadelphia, PA</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Philadelphia, PA</wicri:noRegion></affiliation></author><author><name sortKey="Petrucci, M T" sort="Petrucci, M T" uniqKey="Petrucci M" first="M. T." last="Petrucci">M. T. Petrucci</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Department of Cellular Biotechnologies and Hematology, University 'Sapienza</s1><s2>Rome</s2><s3>ITA</s3><sZ>7 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation></author><author><name sortKey="Yu, Z" sort="Yu, Z" uniqKey="Yu Z" first="Z." last="Yu">Z. Yu</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Celgene Corporation</s1><s2>Summit, NJ</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Celgene Corporation</wicri:noRegion></affiliation></author><author><name sortKey="Olesnyckyj, M" sort="Olesnyckyj, M" uniqKey="Olesnyckyj M" first="M." last="Olesnyckyj">M. Olesnyckyj</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Celgene Corporation</s1><s2>Summit, NJ</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Celgene Corporation</wicri:noRegion></affiliation></author><author><name sortKey="Zeldis, J B" sort="Zeldis, J B" uniqKey="Zeldis J" first="J. B." last="Zeldis">J. B. Zeldis</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Celgene Corporation</s1><s2>Summit, NJ</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Celgene Corporation</wicri:noRegion></affiliation></author><author><name sortKey="Knight, R D" sort="Knight, R D" uniqKey="Knight R" first="R. D." last="Knight">R. D. Knight</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Celgene Corporation</s1><s2>Summit, NJ</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Celgene Corporation</wicri:noRegion></affiliation></author><author><name sortKey="Weber, D M" sort="Weber, D M" uniqKey="Weber D" first="D. M." last="Weber">D. M. Weber</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Department of Lymphoma and Myeloma, The M.D. Anderson Cancer Center</s1><s2>Houston, TX</s2><s3>USA</s3><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Houston, TX</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">10-0003307</idno><date when="2009">2009</date><idno type="stanalyst">PASCAL 10-0003307 INIST</idno><idno type="RBID">Pascal:10-0003307</idno><idno type="wicri:Area/PascalFrancis/Corpus">002992</idno><idno type="wicri:Area/PascalFrancis/Curation">003591</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">002A22</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">002A22</idno><idno type="wicri:doubleKey">0887-6924:2009:Dimopoulos M:long:term:follow</idno><idno type="wicri:Area/Main/Merge">008991</idno><idno type="wicri:Area/Main/Curation">008238</idno><idno type="wicri:Area/Main/Exploration">008238</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Long-term follow-up on overall survival from the MM-009 and MM-010 phase III trials of lenalidomide plus dexamethasone in patients with relapsed or refractory multiple myeloma</title><author><name sortKey="Dimopoulos, M A" sort="Dimopoulos, M A" uniqKey="Dimopoulos M" first="M. A." last="Dimopoulos">M. A. Dimopoulos</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Department of Clinical Therapeutics, University of Athens School of Medicine</s1><s2>Athens</s2><s3>GRC</s3><sZ>1 aut.</sZ></inist:fA14><country>Grèce</country><placeName><settlement type="city">Athènes</settlement><region nuts="2" type="region">Attique (région)</region></placeName></affiliation></author><author><name sortKey="Chen, C" sort="Chen, C" uniqKey="Chen C" first="C." last="Chen">C. Chen</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Medical Oncology and Hematology, Princess Margaret Hospital</s1><s2>Toronto, Ontario</s2><s3>CAN</s3><sZ>2 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Toronto, Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Spencer, A" sort="Spencer, A" uniqKey="Spencer A" first="A." last="Spencer">A. Spencer</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Department of Clinical Haematology and Bone Marrow Transplantation, The Alfred Hospital</s1><s2>Melbourne</s2><s3>AUS</s3><sZ>3 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Niesvizky, R" sort="Niesvizky, R" uniqKey="Niesvizky R" first="R." last="Niesvizky">R. Niesvizky</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Department of Medicine, Weill Cornell Medical College</s1><s2>New York, NY</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>New York, NY</wicri:noRegion></affiliation></author><author><name sortKey="Attal, M" sort="Attal, M" uniqKey="Attal M" first="M." last="Attal">M. Attal</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Department of Hematology, C.H.U. Purpan</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>5 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Stadtmauer, E A" sort="Stadtmauer, E A" uniqKey="Stadtmauer E" first="E. A." last="Stadtmauer">E. A. Stadtmauer</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Abramson Cancer Center, University of Pennsylvania</s1><s2>Philadelphia, PA</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Philadelphia, PA</wicri:noRegion></affiliation></author><author><name sortKey="Petrucci, M T" sort="Petrucci, M T" uniqKey="Petrucci M" first="M. T." last="Petrucci">M. T. Petrucci</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Department of Cellular Biotechnologies and Hematology, University 'Sapienza</s1><s2>Rome</s2><s3>ITA</s3><sZ>7 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation></author><author><name sortKey="Yu, Z" sort="Yu, Z" uniqKey="Yu Z" first="Z." last="Yu">Z. Yu</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Celgene Corporation</s1><s2>Summit, NJ</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Celgene Corporation</wicri:noRegion></affiliation></author><author><name sortKey="Olesnyckyj, M" sort="Olesnyckyj, M" uniqKey="Olesnyckyj M" first="M." last="Olesnyckyj">M. Olesnyckyj</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Celgene Corporation</s1><s2>Summit, NJ</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Celgene Corporation</wicri:noRegion></affiliation></author><author><name sortKey="Zeldis, J B" sort="Zeldis, J B" uniqKey="Zeldis J" first="J. B." last="Zeldis">J. B. Zeldis</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Celgene Corporation</s1><s2>Summit, NJ</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Celgene Corporation</wicri:noRegion></affiliation></author><author><name sortKey="Knight, R D" sort="Knight, R D" uniqKey="Knight R" first="R. D." last="Knight">R. D. Knight</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Celgene Corporation</s1><s2>Summit, NJ</s2><s3>USA</s3><sZ>8 aut.</sZ><sZ>9 aut.</sZ><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Celgene Corporation</wicri:noRegion></affiliation></author><author><name sortKey="Weber, D M" sort="Weber, D M" uniqKey="Weber D" first="D. M." last="Weber">D. M. Weber</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Department of Lymphoma and Myeloma, The M.D. Anderson Cancer Center</s1><s2>Houston, TX</s2><s3>USA</s3><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Houston, TX</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Leukemia</title><title level="j" type="abbreviated">Leukemia</title><idno type="ISSN">0887-6924</idno><imprint><date when="2009">2009</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Leukemia</title><title level="j" type="abbreviated">Leukemia</title><idno type="ISSN">0887-6924</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic agent</term><term>Chemotherapy</term><term>Dexamethasone</term><term>Follow up study</term><term>Hematology</term><term>Human</term><term>Lenalidomide</term><term>Long term</term><term>Myeloma</term><term>Myelosuppression</term><term>Phase III trial</term><term>Relapse</term><term>Survival</term><term>Treatment resistance</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase III</term><term>Long terme</term><term>Etude longitudinale</term><term>Lénalidomide</term><term>Survie</term><term>Homme</term><term>Chimiothérapie</term><term>Récidive</term><term>Résistance traitement</term><term>Dexaméthasone</term><term>Myélosuppression</term><term>Hématologie</term><term>Myélome</term><term>Anticancéreux</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">We present a pooled update of two large, multicenter MM-009 and MM-010 placebo-controlled randomized phase III trials that included 704 patients and assessed lenalidomide plus dexamethasone versus dexamethasone plus placebo in patients with relapsed/refractory multiple myeloma (MM). Patients in both studies were randomized to receive 25 mg daily oral lenalidomide or identical placebo, plus 40 mg oral dexamethasone. In this pooled analysis, using data up to unblinding (June 2005 for MM-009 and August 2005 for MM-010), treatment with lenalidomide plus dexamethasone significantly improved overall response (60.6 vs 21.9%, P< 0.001), complete response rate (15.0 vs 2.0%, P<0.001), time to progression (median of 13.4 vs 4.6 months, P<0.001) and duration of response (median of 15.8 months vs 7 months, P< 0.001 ) compared with dexamethasone-placebo. At a median follow-up of 48 months for surviving patients, using data up to July 2008, a significant benefit in overall survival (median of 38.0 vs 31.6 months, P= 0.045) was retained despite 47.6% of patients who were randomized to dexamethasone-placebo receiving lenalidomide-based treatment after disease progression or study unblinding. Low β<sub>2</sub>-Microglobulin and low bone marrow plasmacytosis were associated with longer survival. In conclusion, these data confirm the significant response and survival benefit with lenalidomide and dexamethasone.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Canada</li><li>France</li><li>Grèce</li><li>Italie</li><li>États-Unis</li></country><region><li>Attique (région)</li><li>Latium</li><li>Midi-Pyrénées</li><li>Occitanie (région administrative)</li><li>Victoria (État)</li></region><settlement><li>Athènes</li><li>Melbourne</li><li>Rome</li><li>Toulouse</li></settlement></list><tree><country name="Grèce"><region name="Attique (région)"><name sortKey="Dimopoulos, M A" sort="Dimopoulos, M A" uniqKey="Dimopoulos M" first="M. A." last="Dimopoulos">M. A. Dimopoulos</name></region></country><country name="Canada"><noRegion><name sortKey="Chen, C" sort="Chen, C" uniqKey="Chen C" first="C." last="Chen">C. Chen</name></noRegion></country><country name="Australie"><region name="Victoria (État)"><name sortKey="Spencer, A" sort="Spencer, A" uniqKey="Spencer A" first="A." last="Spencer">A. Spencer</name></region></country><country name="États-Unis"><noRegion><name sortKey="Niesvizky, R" sort="Niesvizky, R" uniqKey="Niesvizky R" first="R." last="Niesvizky">R. Niesvizky</name></noRegion><name sortKey="Knight, R D" sort="Knight, R D" uniqKey="Knight R" first="R. D." last="Knight">R. D. Knight</name><name sortKey="Olesnyckyj, M" sort="Olesnyckyj, M" uniqKey="Olesnyckyj M" first="M." last="Olesnyckyj">M. Olesnyckyj</name><name sortKey="Stadtmauer, E A" sort="Stadtmauer, E A" uniqKey="Stadtmauer E" first="E. A." last="Stadtmauer">E. A. Stadtmauer</name><name sortKey="Weber, D M" sort="Weber, D M" uniqKey="Weber D" first="D. M." last="Weber">D. M. Weber</name><name sortKey="Yu, Z" sort="Yu, Z" uniqKey="Yu Z" first="Z." last="Yu">Z. Yu</name><name sortKey="Zeldis, J B" sort="Zeldis, J B" uniqKey="Zeldis J" first="J. B." last="Zeldis">J. B. Zeldis</name></country><country name="France"><region name="Occitanie (région administrative)"><name sortKey="Attal, M" sort="Attal, M" uniqKey="Attal M" first="M." last="Attal">M. Attal</name></region></country><country name="Italie"><region name="Latium"><name sortKey="Petrucci, M T" sort="Petrucci, M T" uniqKey="Petrucci M" first="M. T." last="Petrucci">M. T. Petrucci</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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