Leukopenia
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Research from Gunma University broadens understanding of myeloma
2009 JUL 20 - (NewsRx.com) -- "To obtain approval from the Ministry of Health, Labor and Welfare of Japan, a phase II study was conducted to assess the pharmacokinetics and pharmacodynamics of thalidomide along with its efficacy and safety in Japanese patients with multiple myeloma. Between 2005 and 2006, 42 patients were enrolled, and 37 patients met eligibility criteria," scientists in Gunma, Japan report. "Of the 37 patients, 3 were excluded from efficacy analysis because of short duration of thalidomide administration (< 4 weeks). The overall response rate was 35.3% (12/34), including partial response of 14.7% (5/34) and minimal response of 20.6% (7/34). The adverse events observed in high frequency (> 40%) were leukopenia, neutropenia, drowsiness, dry mouth, and constipation. Grade 3 neutropenia was observed in nine cases. Peripheral neuropathy and eruption were observed in about one-quarter of the patients. Deep vein thrombosis was not observed. At a single oral dose of thalidomide (100 mg), the C (max) was 1.68 +/- A 0.41 mu g/ml, T (max) was 4.54 +/- A 1.71 h, T (1/2) was 4.86 +/- A 0.44 h, and AUC was 15.87 +/- A 3.05 mu g h/ml. Low-dose thalidomide was an effective and tolerable treatment for Japanese patients with relapsed/refractory myeloma. Leukopenia and neutropenia were the most serious adverse events," wrote H. Murakami and colleagues, Gunma University. The researchers concluded: "The pharmacokinetics was similar to those observed in Caucasian patients.." Murakami and colleagues published their study in International Journal of Hematology (Phase II and pharmacokinetic study of thalidomide in Japanese patients with relapsed/refractory multiple myeloma. International Journal of Hematology, 2009;89(5):636-641). For additional information, contact H. Murakami, Gunma University, Faculty Medical, School Health Science, Showa Machi 3-39-15, Gunma 3718511, Japan. The publisher's contact information for the International Journal of Hematology is: Springer Tokyo, 1-11-11 Kudan-Kita, Chiyoda-Ku, Tokyo, 102-0073, Japan. Keywords: Japan, Gunma, Adverse Drug Effect, Adverse Drug Event, Adverse Drug Reaction, Clinical Trial Research, Drugs, Hematology, Leukopenia, Multiple Myeloma, Myeloma, Oncology, Pharmaceuticals, Pharmacodynamics, Pharmacokinetics, Regulatory Actions, Thalidomide, Therapies, Therapy, Treatment, Gunma University. This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2009, Biotech Business Week via NewsRx.com.
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