title: [The efficacy and safety of bortezomib plus thalidomide in treatment of newly diagnosed multiple myeloma].
abstract: OBJECTIVE
  The aim of this phase II study was to determine the efficacy and safety of combined bortezomib and thalidomide (VT) regime as initial treatment for newly diagnosed multiple myeloma (MM) in China.
  
  
  METHODS
  Thirty-four patients were enrolled in this study and received VT regime up to 21-day cycles. Bortezomib (1.3 mg/m(2)) was administered intravenously on days 1, 4, 8, and 11, while oral thalidomide (100 mg/day) was given from days 1 to 21. The primary end point was clinical response. The secondary end point was safety.
  
  
  RESULTS
  Among the 34 patients, 20 were male, 14 were female, with a median age of 59 years, and 15 in international stage system (ISS) III, 18 in ISS II, 1 in ISS I. Among them, 28 completed 2 cycles' treatment and achieved an overall response rate (ORR) of 92.9%; 26 were able to complete the planned 8 cycles of therapy. After 8 cycles, the ORR was 100% (complete response 30.8%, near-complete response 23.1%, partial response 42.3%, minimal response 3.8%). After followed up with a median time of 12 months, the estimated rate without progress of disease was 62%, and the estimated continuous remission rate of 12 months was 62%. The median survival time was not achieved. The most common adverse events were mild to moderate (grades 1, 2). The main toxicities were hematologic (53.3%), gastrointestinal (40.0%), peripheral neuropathy (38.0%), fatigue (36.6%) and fever (32.0%).
  
  
  CONCLUSIONS
  VT regime provides a very high ORR and complete response rate in the treatment of newly diagnosed MM patients. No patients experienced deep venous thrombosis. In conclusion, bortezomib in combination with thalidomide is a very effective regimen for newly diagnosed MM patients and the toxicities are manageable.
authors: Department of Hematology, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China. chenslcy@yahoo.com.cn
authors: Shi-Lun
authors: SL
authors: Chen
authors: Lu-Gui
authors: LG
authors: Qiu
authors: Bin
authors: B
authors: Jiang
authors: Li
authors: L
authors: Yu
authors: Yu-Ping
authors: YP
authors: Zhong
authors: Wen
authors: W
authors: Gao