EUCTR2009-016839-35-FR进行中（未招募）1 期
A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Relapsed Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 700
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
- •Disease-related:
- •* Symptomatic multiple myeloma
- •* Measurable disease, as defined by one or both of the following (assessed within 14 days prior to randomization):
- •- Serum M-protein = 0.5 g/dL
- •- Urine Bence-Jones protein = 200 mg/24 hours
- •* Prior treatment with at least one, but no more than three, regimens for multiple myeloma (see Protocol Section 5 for conventions regarding prior regimens)
- •* Documented relapse or progressive disease on or after any regimen (subjects refractory to the most recent line of therapy are eligible)
- •* Achieved a response to at least one prior regimen (defined as = 25% decrease in M-protein [or total protein in countries in which electrophoresis is not routinely available])
- •Demographic
- •* Age = 18 years
- •* Life expectancy = 3 months
- •* Eastern Cooperative Oncology Group (ECOG) performance status 0–2
- •* Adequate hepatic function, with serum ALT = 3.5 times the upper limit of normal and serum direct bilirubin = 2 mg/dL (34 µmol/L) within 14 days prior to randomization
- •* Absolute neutrophil count (ANC) = 1.0 × 10exp9/L within 14 days prior to randomization
- •* Hemoglobin = 8 g/dL (80 g/L) within 14 days prior to randomization (subjects may be receiving red blood cell [RBC] transfusions in accordance with institutional guidelines)
- •* Platelet count = 50 × 10exp9/L (= 30 × 10exp9/L if myeloma involvement in the bone marrow is > 50%) within 14 days prior to randomization
- •* Creatinine clearance (CrCl) = 50 mL/minute (either measured or calculated using a standard formula such as Cockcroft and Gault) within 7 days prior to randomization
- •Ethical/Other
- •* Written informed consent in accordance with federal, local, and institutional guidelines.
- •* Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception according to, and for the timeframe outlined in the RevAssist program (US participants), RevAid program (Canadian participants) or Protocol Appendix F (all other participants).
- •* Male subjects must agree to practice contraception according to, and for the timeframe outlined in the RevAssist program (US participants), RevAid program (Canadian participants) or Protocol Appendix F (all other participants).
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Disease-related
- •* If previously treated with bortezomib (alone or in combination), progression during treatment
- •* If previously treated with a lenalidomide and dexamethasone (len/dex) combination:
- •- Progression during the first 3 months of initiating treatment
- •- Any progression during treatment if the lenalidomide/dexamethasone combination was the subject’s most recent line of therapy
- •* Discontinuation of previous lenalidomide or dexamethasone due to intolerance; subjects intolerant to bortezomib are not excluded
- •* Prior carfilzomib treatment
- •* POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- •* Waldenström’s macroglobulinemia or IgM myeloma
- •* Plasma cell leukemia (> 2.0 × 10exp9/L circulating plasma cells by standard differential)
- •Concurrent Treatments
- •* Chemotherapy or investigational agent within 3 weeks prior to randomization or antibody therapy within 6 weeks prior to randomization
- •* Radiotherapy to multiple sites or immunotherapy/antibody therapy within 28 days prior to randomization; localized radiotherapy to a single site within 7 days prior to randomization
- •* Corticosteroid therapy at a dose equivalent to dexamethasone > 4 mg/day within 21 days prior to randomization
- •Concurrent Conditions
- •* Pregnant or lactating females
- •* Major surgery within 21 days prior to randomization
- •* Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to randomization
- •* Known human immunodeficiency virus infection
- •* Active hepatitis B or C infection
- •* 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
- •* Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to randomization
- •* Other 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
- •* Significant neuropathy (Grades 3–4, or Grade 2 with pain) within 14 days prior to randomization
- •* Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
- •* 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
- •* Ongoing graft-vs-host disease
- •* Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomization
- •* 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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