EUCTR2015-002380-42-PL进行中（未招募）1 期
Phase 3 Randomized trial of carfilzomib, lenalidomide, dexamethasoneversus lenalidomide alone after stem-cell transplant for multiple myeloma.
Polish Myeloma Consortium0 个研究点目标入组 180 人开始时间: 2016年7月20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
- 180
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
- •1)Patients who completed single autologous stem cell transplant after completion of at most 2 induction regimens (excluding dexamethasone alone) and are in at least stable disease prior to randomization in the first 100 days after stem cell transplantation.
- •2)Patient must be within 12 months of initiation of induction therapy and must have had not more than 2 prior induction regimens
- •3)Bone marrow specimen will be required at study entry; available DNA sample from pre-induction BM will be used for calibration step for MRD evaluation by gene sequencing.
- •4)Males and females =18 years of age
- •5)ECOG performance status of 0-1
- •6)Adequate hepatic function, with bilirubin =1.5 x ULN and aspirate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 xULN
- •7)ANC =1.0 x 109/L, hemoglobin =8 g/dL, platelet count =75 x 109/L.
- •8)Calculated creatinine clearance (by Cockroft-Gault) =50 ml/min or serum creatinine below 2 g/dL
- •9)Females of childbearing potential (FCBP) must have 2 negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to initiating lenalidomide. The first pregnancy test must be performed within 10-14 days before and the second pregnancy test must be performed within 24 hours before lenalidomide is prescribed for Cycle 1 (prescriptions must be filled within 7 days).
- •10)FCBP must agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting lenalidomide; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study.
- •11)Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy.
- •12)All study participants must be consented to and registered into the mandatory RevlimidREMS® program and be willing and able to comply with the requirements of RevlimidREMS®.
- •13)Voluntary written informed consent
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1)Patients who have had more than 12 months of prior therapy. Patients outside of this window may be considered for inclusion. Please contact the Sponsor’s representative in Poland or the Lead Primary Investigator as appropriate on a case-by-case basis
- •2)Patients who progressed after initial therapy.
- •a)Subjects whose therapy changed due to suboptimal response, intolerance, etc., remain eligible, provided they do not meet criteria for progression.
- •b)No more than two regimens for induction will be allowed, excluding dexamethasone alone.
- •3)Potential subjects with evidence of progressive disease as per IMWG criteria
- •4)Patients who have already started or received post-transplant maintenance or consolidation regimen
- •5)Patients not able to tolerate lenalidomide or carfilzomib or dexamethasone
- •6)POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- •7)Plasma cell leukemia
- •8)Waldenström’s macroglobulinemia or IgM myeloma
- •9)Peripheral neuropathy = Grade 2 at screening
- •10)Diarrhea > Grade 1 in the absence of antidiarrheals
- •11)CNS involvement
- •12)Pregnant or lactating females
- •13)Radiotherapy within 14 days before randomization. Seven days may be considered if to single area
- •14)Major surgery within 3 weeks prior to first dose
- •15)Myocardial infarction within 3 months prior to enrollment, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- •16)Prior or concurrent deep vein thrombosis or pulmonary embolism
- •17)Rate-corrected QT interval of electrocardiograph (QTc) > 470 msec on a 12-lead ECG during screening
- •18)Uncontrolled hypertension or diabetes
- •19)Acute infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose
- •20)Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
- •21)Non-hematologic malignancy or non-myeloma hematologic malignancy within the past 3 years except a) adequately treated basal cell, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the cervix, or prostate cancer < Gleason Grade 6 with stable prostate specific antigen levels or cancer considered cured by surgical resection alone
- •22)Any 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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