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An Open-Label Study of Pegylated Liposomal Doxorubicin, Vincristine, and Reduced-Dose Dexamethasone Combination Therapy in Newly Diagnosed Multiple Myeloma Patients in the Chinese Population
Authors:Yang Shen  Zhixiang Shen  Bin Jiang  Man Hou  Rong Zhan  Lugui Qiu  Daobin Zhou  Jie Jin  Juan Li  Fanyi Meng  Ping Zou  Ting Liu  Jianyong Li  Chun Wang  Depei Wu  Jun Ma
Abstract:OBJECTIVE Though doxorubicin is highly active in the treatment of multiple myeloma, its toxicity profile limits its therapeutic index. We performed this study to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD, CaelyxR), vincristine, and reduced-dose dexamethasone combination therapy in newly diagnosed multiple myeloma (MM) patients in a Chinese population. METHODS This was an open-label, single-arm study in which newly diagnosed patients with MM received PLD 40 mg/m2 intravenously on Day 1, vincristine 1.4 mg/m2 intravenously (maximum 2 mg) on Day 1, and 40 mg of dexamethasone (intravenously or orally) from Day 1 to Day 4. Treatment was repeated every 28 days for at least 4 cycles. RESULTS In the intent-to-treat (ITT) analysis, the overall response rate was 68.29%, and the complete remission rate was 10.98%. The incidence of all adverse events was 46.34%. The most common non-hematologic toxicities were palmar-plantar erythrodysesthesia (13.4%) and stomatitis (6.1%). CONCLUSION PLD, vincristine, and a reduced-dose dexamethasone combination (DVd) is an effective and safe regimen in newly diagnosed MM patients in a Chinese population.
Keywords:pegylated liposomal doxorubicin  multiple myeloma  chemotherapy
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