AustralieFrV1, Main, Exploration, bibRecord, 009496

Lenalidomide plus Dexamethasone for Relapsed or Refractory Multiple Myeloma

Identifieur interne : 009496 ( Main/Exploration ); précédent : 009495; suivant : 009497

Lenalidomide plus Dexamethasone for Relapsed or Refractory Multiple Myeloma

Auteurs : Meletios Dimopoulos [Grèce] ; Andrew Spencer [Australie] ; Michael Attal [France] ; H. Miles Prince [Australie] ; Jean-Luc Harousseau [France] ; Anna Dmoszynska [Pologne] ; Jesus San Miguel [Espagne] ; Andrzej Hellmann [Pologne] ; Thierry Facon [France] ; Robin Foa [Italie] ; Alessandro Corso [Italie] ; Zvenyslava Masliak [Ukraine] ; Marta Olesnyckyj [États-Unis] ; ZHINUAN YU [États-Unis] ; John Patin [États-Unis] ; Jerome B. Zeldis [États-Unis] ; Robert D. Knight [États-Unis]

Source :

The New England journal of medicine [ 0028-4793 ] ; 2007.

RBID : Pascal:08-0020004

Descripteurs français

Pascal (Inist)
- Myélome, Lénalidomide, Association médicamenteuse, Dexaméthasone, Récidive, Résistance traitement, Réfractaire, Médecine, Immunomodulateur, Antiinflammatoire.
Wicri :
- topic : Médecine.

English descriptors

KwdEn :
- Antiinflammatory agent, Dexamethasone, Drug combination, Immunomodulator, Lenalidomide, Medicine, Myeloma, Refractory, Relapse, Treatment resistance.

Abstract

BACKGROUND Lenalidomide is a structural analogue of thalidomide with similar but more potent biologic activity. This phase 3, placebo-controlled trial investigated the efficacy of lenalidomide plus dexamethasone in the treatment of relapsed or refractory multiple myeloma. METHODS Of 351 patients who had received at least one previous antimyeloma therapy, 176 were randomly assigned to receive 25 mg of oral lenalidomide and 175 to receive placebo on days 1 to 21 of a 28-day cycle. In addition, all patients received 40 mg of oral dexamethasone on days 1 to 4, 9 to 12, and 17 to 20 for the first four cycles and subsequently, after the fourth cycle, only on days 1 to 4. Patients continued in the study until the occurrence of disease progression or unacceptable toxic effects. The primary end point was time to progression. RESULTS The time to progression was significantly longer in the patients who received lenalidomide plus dexamethasone (lenalidomide group) than in those who received placebo plus dexamethasone (placebo group) (median, 11.3 months vs. 4.7 months; P<0.001). A complete or partial response occurred in 106 patients in the lenalidomide group (60.2%) and in 42 patients in the placebo group (24.0%, P<0.001), with a complete response in 15.9% and 3.4% of patients, respectively (P<0.001). Overall survival was significantly improved in the lenalidomide group (hazard ratio for death, 0.66; P=0.03). Grade 3 or 4 adverse events that occurred in more than 10% of patients in the lenalidomide group were neutropenia (29.5%, vs. 2.3% in the placebo group), thrombocytopenia (11.4% vs. 5.7%), and venous thromboembolism (11.4% vs. 4.6%). CONCLUSIONS Lenalidomide plus dexamethasone is more effective than high-dose dexamethasone alone in relapsed or refractory multiple myeloma.

Affiliations:

Australie, Espagne, France, Grèce, Italie, Pologne, Ukraine, États-Unis
Attique (région), Hauts-de-France, Latium, Midi-Pyrénées, Nord-Pas-de-Calais, Occitanie (région administrative), Pays de la Loire, Victoria (État)
Athènes, Lille, Melbourne, Nantes, Rome, Toulouse

Links toward previous steps (curation, corpus...)

to stream PascalFrancis, to step Corpus: 003812
to stream PascalFrancis, to step Curation: 002826
to stream PascalFrancis, to step Checkpoint: 003796
to stream Main, to step Merge: 009F08
to stream Main, to step Curation: 009496

Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Lenalidomide plus Dexamethasone for Relapsed or Refractory Multiple Myeloma</title>
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<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Celgene</wicri:noRegion>
</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 wicri:level="1"><inist:fA14 i1="13"><s1>Celgene</s1>
<s2>Summit, NJ</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Celgene</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">The New England journal of medicine</title>
<title level="j" type="abbreviated">N. Engl. j. med.</title>
<idno type="ISSN">0028-4793</idno>
<imprint><date when="2007">2007</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">The New England journal of medicine</title>
<title level="j" type="abbreviated">N. Engl. j. med.</title>
<idno type="ISSN">0028-4793</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiinflammatory agent</term>
<term>Dexamethasone</term>
<term>Drug combination</term>
<term>Immunomodulator</term>
<term>Lenalidomide</term>
<term>Medicine</term>
<term>Myeloma</term>
<term>Refractory</term>
<term>Relapse</term>
<term>Treatment resistance</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Myélome</term>
<term>Lénalidomide</term>
<term>Association médicamenteuse</term>
<term>Dexaméthasone</term>
<term>Récidive</term>
<term>Résistance traitement</term>
<term>Réfractaire</term>
<term>Médecine</term>
<term>Immunomodulateur</term>
<term>Antiinflammatoire</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Médecine</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">BACKGROUND Lenalidomide is a structural analogue of thalidomide with similar but more potent biologic activity. This phase 3, placebo-controlled trial investigated the efficacy of lenalidomide plus dexamethasone in the treatment of relapsed or refractory multiple myeloma. METHODS Of 351 patients who had received at least one previous antimyeloma therapy, 176 were randomly assigned to receive 25 mg of oral lenalidomide and 175 to receive placebo on days 1 to 21 of a 28-day cycle. In addition, all patients received 40 mg of oral dexamethasone on days 1 to 4, 9 to 12, and 17 to 20 for the first four cycles and subsequently, after the fourth cycle, only on days 1 to 4. Patients continued in the study until the occurrence of disease progression or unacceptable toxic effects. The primary end point was time to progression. RESULTS The time to progression was significantly longer in the patients who received lenalidomide plus dexamethasone (lenalidomide group) than in those who received placebo plus dexamethasone (placebo group) (median, 11.3 months vs. 4.7 months; P<0.001). A complete or partial response occurred in 106 patients in the lenalidomide group (60.2%) and in 42 patients in the placebo group (24.0%, P<0.001), with a complete response in 15.9% and 3.4% of patients, respectively (P<0.001). Overall survival was significantly improved in the lenalidomide group (hazard ratio for death, 0.66; P=0.03). Grade 3 or 4 adverse events that occurred in more than 10% of patients in the lenalidomide group were neutropenia (29.5%, vs. 2.3% in the placebo group), thrombocytopenia (11.4% vs. 5.7%), and venous thromboembolism (11.4% vs. 4.6%). CONCLUSIONS Lenalidomide plus dexamethasone is more effective than high-dose dexamethasone alone in relapsed or refractory multiple myeloma.</div>
</front>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>Espagne</li>
<li>France</li>
<li>Grèce</li>
<li>Italie</li>
<li>Pologne</li>
<li>Ukraine</li>
<li>États-Unis</li>
</country>
<region><li>Attique (région)</li>
<li>Hauts-de-France</li>
<li>Latium</li>
<li>Midi-Pyrénées</li>
<li>Nord-Pas-de-Calais</li>
<li>Occitanie (région administrative)</li>
<li>Pays de la Loire</li>
<li>Victoria (État)</li>
</region>
<settlement><li>Athènes</li>
<li>Lille</li>
<li>Melbourne</li>
<li>Nantes</li>
<li>Rome</li>
<li>Toulouse</li>
</settlement>
</list>
<tree><country name="Grèce"><region name="Attique (région)"><name sortKey="Dimopoulos, Meletios" sort="Dimopoulos, Meletios" uniqKey="Dimopoulos M" first="Meletios" last="Dimopoulos">Meletios Dimopoulos</name>
</region>
</country>
<country name="Australie"><noRegion><name sortKey="Spencer, Andrew" sort="Spencer, Andrew" uniqKey="Spencer A" first="Andrew" last="Spencer">Andrew Spencer</name>
</noRegion>
<name sortKey="Prince, H Miles" sort="Prince, H Miles" uniqKey="Prince H" first="H. Miles" last="Prince">H. Miles Prince</name>
</country>
<country name="France"><region name="Occitanie (région administrative)"><name sortKey="Attal, Michael" sort="Attal, Michael" uniqKey="Attal M" first="Michael" last="Attal">Michael Attal</name>
</region>
<name sortKey="Facon, Thierry" sort="Facon, Thierry" uniqKey="Facon T" first="Thierry" last="Facon">Thierry Facon</name>
<name sortKey="Harousseau, Jean Luc" sort="Harousseau, Jean Luc" uniqKey="Harousseau J" first="Jean-Luc" last="Harousseau">Jean-Luc Harousseau</name>
</country>
<country name="Pologne"><noRegion><name sortKey="Dmoszynska, Anna" sort="Dmoszynska, Anna" uniqKey="Dmoszynska A" first="Anna" last="Dmoszynska">Anna Dmoszynska</name>
</noRegion>
<name sortKey="Hellmann, Andrzej" sort="Hellmann, Andrzej" uniqKey="Hellmann A" first="Andrzej" last="Hellmann">Andrzej Hellmann</name>
</country>
<country name="Espagne"><noRegion><name sortKey="San Miguel, Jesus" sort="San Miguel, Jesus" uniqKey="San Miguel J" first="Jesus" last="San Miguel">Jesus San Miguel</name>
</noRegion>
</country>
<country name="Italie"><region name="Latium"><name sortKey="Foa, Robin" sort="Foa, Robin" uniqKey="Foa R" first="Robin" last="Foa">Robin Foa</name>
</region>
<name sortKey="Corso, Alessandro" sort="Corso, Alessandro" uniqKey="Corso A" first="Alessandro" last="Corso">Alessandro Corso</name>
</country>
<country name="Ukraine"><noRegion><name sortKey="Masliak, Zvenyslava" sort="Masliak, Zvenyslava" uniqKey="Masliak Z" first="Zvenyslava" last="Masliak">Zvenyslava Masliak</name>
</noRegion>
</country>
<country name="États-Unis"><noRegion><name sortKey="Olesnyckyj, Marta" sort="Olesnyckyj, Marta" uniqKey="Olesnyckyj M" first="Marta" last="Olesnyckyj">Marta Olesnyckyj</name>
</noRegion>
<name sortKey="Knight, Robert D" sort="Knight, Robert D" uniqKey="Knight R" first="Robert D." last="Knight">Robert D. Knight</name>
<name sortKey="Patin, John" sort="Patin, John" uniqKey="Patin J" first="John" last="Patin">John Patin</name>
<name sortKey="Zeldis, Jerome B" sort="Zeldis, Jerome B" uniqKey="Zeldis J" first="Jerome B." last="Zeldis">Jerome B. Zeldis</name>
<name sortKey="Zhinuan Yu" sort="Zhinuan Yu" uniqKey="Zhinuan Yu" last="Zhinuan Yu">ZHINUAN YU</name>
</country>
</tree>
</affiliations>
</record>

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Lenalidomide plus Dexamethasone for Relapsed or Refractory Multiple Myeloma

Lenalidomide plus Dexamethasone for Relapsed or Refractory Multiple Myeloma

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