EUCTR2020-001102-29-DK进行中（未招募）1 期
Venetoclax and Dexamethasone in translocation (11;14) positive relapsed and refractory multiple myeloma (VICTORIA)
Department of Internal Medicine Vejle Hospital0 个研究点目标入组 70 人开始时间: 2020年4月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female, age 18 years or older;
- •A prior diagnosis of multiple myeloma;
- •At least one prior line of therapy;
- •The presence of t(11;14) by fluorescent in situ hybridization
- •Relapsed or refractory disease defined as
- •oprogressive disease
- •?during treatment with the last line of therapy or
- •?within 60 days after the last line of therapy or
- •ominimal response or better not achieved after completion of at least two cycles of the last line of therapy
- •Measurable disease defined as any of the following:
- •oSerum monoclonal protein = 10 g/L by serum protein electrophoresis
- •o = 200 mg of monoclonal protein in the urine on 24-hour electrophoresis
- •oSerum free light chain = 100 mg/L and abnormal serum kappa to lambda free light chain (FLC) ratio
- •Life expectancy of = 6 months;
- •ECOG performance status = 2. (Patients with performance status > 2 based solely on bone pain secondary to multiple myeloma may be eligible following approval of the sponsor);
- •A negative serum or urine pregnancy test if the subject is a female of childbearing potential, defined as any sexually mature female who:
- •ohas not undergone a hysterectomy or bilateral oophorectomy and
- •ohas not been naturally postmenopausal for at least 24 consecutive months
- •?A sexually mature female who stopped having menstrual cycles due to cancer therapy cannot be considered naturally postmenopausal
- •Patient agrees to practice appropriate methods of birth control;
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent;
- •Adequate organ function with the following laboratory results:
- •oAbsolute neutrophil count = 1,000 cells/mm3 (1.0 x 109/L)
- •oPlatelet count = 30,000 cells/ mm3 (30 x 109/L) (without transfusions required within 10 days prior to initiation of study treatment)
- •oHemoglobin = 5 mmol/l; red blood cell transfusions and treatment with erythropoietin are permitted
- •oTotal Bilirubin = 1.5 x upper limit of normal, except patients diagnosed with Gilbert’s syndrome that have been approved by the sponsor
- •oAlanine transaminase = 3.0 x upper limit of normal
- •oRenal function: Estimated creatinine clearance by Cockcroft- Gault formula of = 30 mL/min
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Any somatic or psychiatric condition that in the investigator’s opinion would impose excessive risk to the patient or would adversely affect the patient’s participation in this study;
- •Severe ongoing infection that in the investigator’s opinion would impose excessive risk to the patient
- •Known intolerance to the study treatment;
- •Pregnant or breast-feeding females;
- •Known human immunodeficiency virus or active hepatitis B or C viral infection;
- •The use of live vaccines within 30 days before initiation of study treatment;
- •Autologous stem cell transplant within 12 weeks prior to initiation of study treatment;
- •Prior allogeneic stem cell transplantation with active graft-versus-host-disease;
- •= Grade 3 cardiac conduction system abnormalities unless patient has a pacemaker
- •Cardiovascular disability status of New York Heart Association Class greater than or equal to 3
研究者
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