ACTRN12615000818538已完成2 期
Single arm, multicentre study evaluating the safety and efficacy of Carfilzomib in combination with Thalidomide and Dexamethasone (CaTD) in patients with relapsed and/or refractory multiple myeloma (RRMM).
Australiasian Leukaemia and Lymphoma Group0 个研究点目标入组 91 人开始时间: 2015年8月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 91
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Male and female patients, > or =18 years of age
- •2.Relapsed and/or refractory multiple myeloma at study entry.
- •3.Patients must have evaluable multiple myeloma with at least one of the following (assessed within 21 days prior to registration):
- •a.Serum M-protein > or = 5 g/L, or
- •b.Urine M-protein > or = 200 mg/24 hour, or
- •In patients without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal serum k/l ratio or
- •For IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) > or = 7500 mg/L (7.5 g/L).
- •4.Received at least one, but no more than three prior treatment regimens or lines of therapy for multiple myeloma. (Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy).
- •5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- •6.Adequate hepatic function within 28 days prior to registration with bilirubin < 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN.
- •7.Left Ventricular Ejection Fraction (LVEF) > or = 40%.
- •8.Absolute neutrophil count (ANC) > or = 1000/mm3 (or 1000 cells/microL) within 21 days prior to registration. Screening ANC should be independent of growth factor support for > or = 1 week.
- •9.Platelet count > or = 50,000 cells/mm^3 (> or = 30,000 cells/mm3 if myeloma involvement in the bone marrow is > 50%) within 21 days prior to registration. Patients should not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count.
- •10.Calculated or measured creatinine clearance (CrCl) of > or =15 mL/min within 21 days prior to registration. Calculation should be based on the Cockcroft and Gault formula
- •11.Written informed consent in accordance with federal, local, and institutional guidelines.
- •12.Female patients of child-bearing potential (FCBP) must have negative serum pregnancy test within 21 days prior to registration and agree to use an effective method of contraception during and for 3 months following last dose of drug.
- •13.Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP.
排除标准
- •1.Chemotherapy with approved or investigational anticancer therapeutics within 21 days prior to registration, with the exception of dexamethasone up to 160mg or equivalent every 4 weeks.
- •2.Previous treatment with carfilzomib.
- •3.Focal radiation therapy within 7 days prior to registration. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to registration (i.e., prior radiation must have been to less than 30% of the bone marrow).
- •4.Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within four months prior to registration.
- •5.Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents within 14 days prior to registration.
- •6.Known HIV seropositive and/or untreated hepatitis B (patients with hepatitis B surface antigen [HBsAg] and core antibody [HBcAb] are eligible if receiving adequate antiviral therapy directed at hepatitis B).
- •7.Patients with known cirrhosis.
- •8.Active malignancy, that is expected to require treatment with chemotherapy within one year, or results in a life expectancy less than one year.
- •9.Female patients who are pregnant or lactating.
- •10.Known history of allergy to Captisol (registered trademark) (a cyclodextrin derivative used to solubilise carfilzomib)
- •11.Patients with hypersensitivity to carfilzomib, velcade, boron, or mannitol.
- •12.Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to registration.
- •13.Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to registration.
- •14.Any other clinically significant medical disease or psychiatric condition that, in the Investigator’s opinion, may interfere with protocol adherence or a patient’s ability to give informed consent.
研究者
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