| Budget Amount *help |
¥4,810,000 (Direct Cost: ¥3,700,000、Indirect Cost: ¥1,110,000)
Fiscal Year 2016: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2015: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2014: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
|
|---|
| Outline of Final Research Achievements |
Lenalidomide (Len) is an immuno-modulatory key drug for multiple myeloma (MM). However, adverse events (AEs) make continuation of Len difficult for some patients especially for elderly patients. The purpose of this study is to investigate the safe and effective plasma concentration of Len and the anti-tumor immune response change. Forty patients were enrolled in this study. The plasma concentrations of Len were analyzed by using liquid chromatography-tandem mass spectrometry. Peripheral blood mononuclear cells were evaluated for the profile of immune cells by multicolor flow-cytometry. Overall response rate was 68.6 % and 3-year progression-free survival was 57.2%. In a multivariate logistic analysis, AUC0-24 was a significant predictor for grade ≧ 2 hematologic AEs and trough level (C0) for grade ≧ 2 non-hematologic AEs. After Len therapy, effector memory subset and intracellular cytokine productions CD4 and CD8 T cells increased significantly.
|
