A Randomized Phase 3 Trial Of Thalidomide And Prednisone (Tp) As Maintenance Therapy Following Autologous Stem Cell Transplantation (Asct) In Patients With Multiple Myeloma (Mm): An Updated Analysis Of The Ncic Clinical Trials Group My10 Trial.

JOURNAL OF CLINICAL ONCOLOGY(2014)

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摘要
8591 Background: Primary analysis of the MY.10 trial (Stewart, Blood 2013) demonstrated, with a median f/u of 4.1 yrs, MM patients completing ASCT and randomized to receive 4 yrs of TP experienced superior progression free survival (PFS) and poorer quality of life scores as compared with those randomized to observation. No differences in overall survival (OS) were detected (HR=0.77). We now report long term survival. Methods: From 2002-09, 332 patients were enrolled. Primary endpoint was OS; secondary endpoints were myeloma-specific PFS (MS-PFS) defined as time from randomization to progressive myeloma, and PFS which also includes death without myeloma progression as an event. Trial arms were compared with a stratified (by age and response to transplant) log-rank test; all analyses were by intent-to-treat. This report is based on the final 2013 December 20 locked database. Results: Median age at study entry was 58 years. Among 166 TP patients, 8 (5%) completed 4 years of at least one drug. With a median f...
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关键词
multiple myeloma,autologous stem cell transplantation,clinical trials,thalidomide
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