ACTRN12615000188538进行中（未招募）2 期
A Multicenter, Phase II study to assess the response rate of subjects with newly diagnosed Multiple Myeloma when treated with Carfilzomib (Kyprolis),Cyclophosphamide and Dexamethasone as induction followed by an autologous bone marrow transplant and Carfilzomib (Kyprolis), Thalidomide and Dexamethasone as consolidation.
orth Shore Haematology Clinical Trial Unit0 个研究点目标入组 50 人开始时间: 2015年2月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Disease-related:
- •1.Newly diagnosed symptomatic multiple myeloma
- •2.Transplant-eligible (according to local criteria)
- •Demographic:
- •3.Age 18- 70years
- •4.Life expectancy greater than or equal to 3 months
- •5.Eastern Cooperative Oncology Group (ECOG) performance status 0–2
- •6.Adequate hepatic function, with serum ALT less than or equal to 3.5 times the upper limit of normal and serum direct bilirubin less than or equal to 34 micromol/L within 14 days prior to enrollment
- •7.Absolute neutrophil count (ANC) greater than or equal to 1.0 × 109/L within 14 days prior to enrollment
- •8.Hemoglobin greater than or equal to 80 g/L within 14 days prior to enrollment (subjects may be receiving red blood cell [RBC] transfusions in accordance with institutional guidelines)
- •9.Platelet count greater than or equal to 50× 109/L (equal to 30 × 109/L if myeloma involvement in the bone marrow is > 50%) within 14 days prior to enrollment
- •10.Creatinine clearance (CrCl) greater than or equal to 15 mL/minute within 7 days prior to enrollment, either measured or calculated using a standard formula (eg, Cockcroft and Gault)
- •Ethical/Other
- •11.Written informed consent in accordance with local, and institutional guidelines.
- •12.Women of childbearing potential must have a negative serum pregnancy test within the 7 days prior to study drug administration and a negative urine pregnancy test within the 3 days prior to the first study drug administration.
- •13.Women of childbearing potential and male subjects who are sexually active with WOCBP must agree to use 2 highly effective methods of contraception during the study and for 30 days following the last dose of study treatment including a male condom.
排除标准
- •Disease-related
- •1. Multiple Myeloma of IgM subtype.
- •2. Glucocorticoid therapy within 14 days prior to enrollment that equals or exceeds a cumulative dose of 160 mg of dexamethasone.
- •3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- •4. Plasma cell leukemia (greater than 2.0 × 109/L circulating plasma cells by standard differential).
- •5. Waldenstrom macroglobulinemia (WM).
- •6. Known amyloidosis.
- •7. Any immunotherapy for myeloma within 21 days prior to enrollment.
- •Concurrent Conditions
- •8.Pregnant or lactating females
- •9.Major surgery within 21 days prior to enrollment(unless related to myeloma)
- •10.Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to enrollment
- •11.Known human immunodeficiency virus infection
- •12.Active hepatitis B or C infection
- •13.Unstable angina or myocardial infarction within 4 months prior to randomization, NYHA Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker
- •14. Pulmonary Hypertension
- •15.LVEF of less than 40%
- •16.Uncontrolled hypertension or uncontrolled diabetes
- •17.Nonhematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
- •18.Significant neuropathy (Grades 3–4, or Grade 2 with pain) within 14 days prior to enrollment
- •19.Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)
- •20.Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
- •21.Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrollment
- •22.Any other clinically significant medical disease or condition that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent
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