A Prospective Multicenter Phase II Study of Consolidation with Cyclophosphamide, Bortezomib, and Dexamethasone (CVD) in Patients with Multiple Myeloma after Autologous Stem Cell Transplantation
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 45
研究概览
简要总结
Abstract: The three-drug combination of cyclophosphamide, bortezomib and dexamethasone (CVD) has shown significant efficacy and manageable toxicity as induction therapy in patients with multiple myeloma (MM). In this phase II study, 45 patients achieving very good partial response (VGPR) or partial response (PR) after autologous stem cell transplantation (ASCT) were enrolled, and the efficacy and toxicity of CVD consolidation was evaluated. CVD consolidation consisted of three cycles of cyclophosphamide 300 mg/m2orallyondays1,8,15andbortezomib1.3mg/m2subcutaneouslyondays1,8,15and22,al ongwithdexamethasone20mgpermouthondays1-2,8-9,15-16and22-23.Attheenrollment,3 9(86.7%)patientsshowedVGPRand6(13.3%)presentedPR.Nineteen(45.2%)patientsachie vedcompleteresponse(CR)ormoreastheirbestresponseaftertheendofconsolidation.Overall ,22(52.4%)of42availablepatientsexperiencedtheimprovedresponsestatuswithCVDconsol idation.Three-yearoverallsurvivalandprogression-freesurvivalwere89.0%and42.7%,resp ectively.Themostcommonnon-hematologictoxicitieswereperipheralneuropathyandinfecti on(20.5%,respectively)withoutgrade3ormoreneuropathy.Inconclusion,consolidationther apywithCVDappearstoimproveresponsewithreasonabletoxicityinpatientswhohaveresidu aldiseaseafterASCT.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 64(Year)（—）
- 性别
- All
入选标准
- •1) Patients with multiple myeloma treated with one or more induction regimens and autologous stem cell transplantation
- •2) age 20 ~ 64
- •3) patients who were treated with thalidomide-based regimen or VAD-like induction regimens
- •4) patients who acheived very good partial response (VGPR) or near complete response (nCR) whitn 12 weeks after autologous stem cell transplantation
- •5) Treated with 140 ~ 200 mg/m2 of melphalan as a conditioning
- •6) adequate bone marrow function;
- •ANC > 1,000/uL
- •Hemoglobin > 9.0 g/dL
- •Platelets > 70 x 103/uL
- •7) adequate hepatic function; Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) < 3 times of the upper normal limit, total Bilirubin < 3 times of the upper normal limit
- •8) adequate cardiac function; no clinically relevant symptoms of heart failure, left ventricular ejection fraction >= 50% (measured by echocardiography or MUGA scan)
- •9) adequate performance status; ECOG performance scale 0-2
- •10) negative pregnancy test (serum or urine) before study initiation or persistent amenorrhea for more than 1 years, for women in the reproductive age
- •11) patients who agree with keep adequate contraception
- •12) patients who are expected to survive for more than 6 months
- •13) patients who voluntarily agreed and signed the informed consent
排除标准
- •1) primary amyloidosis, smoldering myeloma, MGUS
- •2) plasmacytic leukemia
- •3) peripheral neuropathy > grade 2 at the enrollment
- •4) Ongoing toxicity due to previous treatment > grade 2
- •5) Progressive disease after ASCT
- •6) additional chemotherapy or radiation after ASCT
- •7) Serious medicall illness or psychologic problems
- •8) HIV positivity
- •9) Active HBV or HCV infection
- •10) Hypersensitivity to bortezomib, boron, or mannitol
- •11) active, severe infection that required immediate treatment
- •12) pregnant or lactating women
- •13) Serious cardiovascular diseases
- •14) Previous history of malignancy within 5 years except non-basal cell skin cancer and in situ carcinoma of cervix uteri
- •15) patients who are administered study drugs as a part of other clinical trials , any chemotherapeutic agents, or immunotherapy
- •16) patients who are in any medical condition not adequate to enroll this clinical trial determined by the investigator