Post-marketing surveillance of the treatment with THALED® CAPSULE in patients with relapsed/refractory multiple myeloma

抄録

THALED® CAPSULE (thalidomide) was approved as a drug for relapsed/refractory multiple myeloma (MM) in October 2008 in Japan. Because the number of patients included in the domestic clinical study was small, the post-marketing surveillance was necessary and was conducted accordingly. This study included 1,548 patients during a period from February 2009 to February 2010. The mean age was 68.5 years, and the male/female ratio was 1.03. Mean disease duration was 3.8 years from the diagnosis of myeloma. Almost all patients (98.5%) were treated at a dosage below 200 mg/day. All grade and serious adverse events (AEs) were observed in 58.6% and 8.7%, respectively. The incidence of these AEs was lower than that observed in the previous domestic clinical study; however the monitoring and audit was not performed in this surveillance, so that the low grade AEs might have been missed. Main AEs were peripheral neuropathy, constipation, somnolence and leukopenia. Serious AEs were leukopenia, pneumonia, neutropenia and peripheral neuropathy. Venous thromboembolism (VTE) was observed only in 1.4%. Median overall survival was not reached, and median duration of treatment was 24.0 weeks. It is difficult to compare the present data with the other data because this is a post-marketing surveillance. However, the incidence of AEs, especially VTE, was obviously lower than that reported in western countries, so that THALED® CAPSULE can be used safely in clinical practice of Japanese MM patients.