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Pomalidomid verlängert die Überlebenszeit von refraktären Myelompatienten
Date:6/14/2013

STOCKHOLM, June 14, 2013 /PRNewswire/ --

Dr. Jesus San-Miguel wird vielversprechende Ergebnisse einer Phase-3-Studie an multiplen Myelomen präsentieren.

Die Behandlung von Patienten mit multiplen Myelomen (MM) hat sich mit der Einführung neuer Arzneimittel wie Lenalidomid und Bortezomib im Laufe des vergangenen Jahrzehnts verbessert. MM-Patienten entwickeln nach mehreren Behandlungen jedoch häufig eine Resistenz (refraktär) gegenüber diesen Arzneimitteln, weshalb ihre durchschnittliche Überlebenszeit nur 9 Monate beträgt.

MM-003 ist eine umfangreiche multizentrische Phase-3-Studie, in dessen Rahmen die Wirksamkeit und Sicherheit des neuen Arzneimittels Pomalidomid (POM) in Kombination mit einer niedrigen Dosis Dexamethason (POM + LoDex) bei MM-Patienten im Spätstadium bewertet wurde, deren bisherige Behandlung mit Lenalidomid und Bortezomib erfolglos verlaufen war. Diese Kombination wurde dann mit Dexamethason in hoher Dosierung verglichen. Die Studie lieferte klinisch und statistisch bedeutende positive Ergebnisse. Sowohl das progressionsfreie Überleben (PFS) als auch das Gesamtüberleben (OS) konnten mithilfe von POM + LoDex im Vergleich zu einer hohen Dex-Dosierung deutlich verbessert werden (PFS: 4,0 Monate vs. 1,9 Monate; OS: 12,7 vs. 8,1 Monate).

Dabei wurde nachgewiesen, dass POM + LoDex ein gutes Sicherheitsprofil aufweist und dass die Nebenwirkungen überschaubar waren: Nur eine geringe Anzahl der Patienten brach die Behandlung aufgrund von Nebenwirkungen ab. Überdies schien die Behandlung mit Pomalidomid auch die Lebensqualität der Patienten zu erhöhen, was bei fortgeschrittenem Krankheitsverlauf ein wichtiges Behandlungsziel ist. Für Patienten, deren Erkrankung auf derzeitige Standardbehandlungen nicht mehr anspricht, hat die Kombination von Pomalidomid und Dexamethason in niedriger Dosierung z
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SOURCE European Hematology Association
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