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

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 effi cacy and safety of pegylated liposomal doxorubicin (PLD, Caelyx®), vincristine, and reduced-dose dexamethasone combinati...

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Published inCancer biology & medicine Vol. 6; no. 2; p. 394
Main Authors SHEN, Yang, SHEN, Zhixiang, JIANG, Bin, HOU, Jian, ZHAN, Rong, QIU, Lugui, ZHOU, Daobin, JIN, Jie, LI, Juan, MENG, Fanyi, ZOU, Ping, LIU, Ting, LI, Jianyong, WANG, Chun, WU, Depei, MA, Jun
Format Journal Article
LanguageEnglish
Published Tianjin Chinese Anti-Cancer Association (CACA), Cancer Biology & Medicine 01.04.2009
Subjects
Dexamethasone
Doxorubicin
Health risk assessment
Multiple myeloma
Patients
Remission
Stomatitis
Toxicity
Vincristine
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Summary: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 effi cacy and safety of pegylated liposomal doxorubicin (PLD, Caelyx®), 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.
ISSN:2095-3941