Unstable plasma thalidomide concentration in patients with refractory multiple myeloma.

In this study, we analyzed the relationship between the plasma concentration of thalidomide and the therapeutic effect obtained by using thalidomide alone in patients with refractory multiple myeloma. The safety and effect of thalidomide was examined in 12 cases of refractory multiple myeloma. Four cases (33%) achieved partial response (PR) and 3 cases (25%) achieved minimal response. These effects were achieved with only 200 mg/day of thalidomide and maintained with 100-200 mg/day. The concentration of thalidomide in the blood was measured in 7 cases; dose-dependency was not recognized. In 5 cases in which complete or partial response was obtained, the effect was obtained with a mean thalidomide concentration in blood of 0.5 microg/mL or less. However, in 2 cases in which the mean blood concentration of thalidomide was 2 microg/mL or higher, an M-protein-reducing effect was not obtained. The frequency of various side effects was increased when the concentration of thalidomide was higher than 2 microg/mL. In conclusion, low-dose thalidomide therapy may effectively treat refractory myeloma, and the measurement of thalidomide concentration in the blood may not be a marker of therapeutic effect, but rather a marker of adverse effects.