EUCTR2017-001013-89-IT进行中（未招募）1 期
Double ASCT in MM: phase III study comparing between melphalan based regimen vs a new regimen consisting of melphalan and thiotepa - DAMTE
AZIENDA OSPEDALIERA BIANCHI-MELACRINO-MORELLI0 个研究点目标入组 292 人开始时间: 2021年9月6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
- 292
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
- •All individuals must meet all of the inclusion criteria in order to be eligible to participate in the study:
- •Multiple myeloma diagnosis according to IMWG 2014
- •Baseline cytogenetics data available
- •Mobilized stem cells at least 4x106/Kg
- •At least SD after the first auto-HSCT
- •Second auto-HSCT if clinical and hematological disease progression, and not earlier than 3 months and not later than 6 months from the first disease progression evidence.
- •Durie & Salmon stage II-III or I with disease progression.
- •Karnofsky performance status = 60
- •Willing and able to comply with all the protocol requirements.
- •Adequate hepatic function, with serum (alanine aminotransferase) ALT = 3 times the upper limit of normal and serum direct bilirubin = 2 mg/dL (34 µmol/L) within 14 days prior to randomization
- •DLCO =40%, TLC =40%, FEV1=40%
- •Absolute neutrophil count (ANC) = 1.0 × 109/L within 14 days prior to randomization
- •Platelet count = 50 × 109/L
- •Creatinine clearance (CrCl) = 30 mL/minute within 7 days prior to randomization, either measured or calculated using a standard formula (eg, Cockcroft and Gault)
- •Corrected serum calcium = 14 mg/dL (3.5 mmol/L)
- •LVEF = 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available.
- •For females of reproductive potential: use of highly effective contraception. Women of child-bearing potential and men must agree to take adequate contraceptive measures in order to avoid any pregnancies of their sexual partners during the course of the study (or for at least 3 months following the last dose of study drug, whichever is longer). Acceptable methods of birth control include oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device IUD) or intrauterine system (IUS), barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/ film/ cream/suppository. Abstinence is only considered an acceptable form of contraception when it is the usual life style of an individual*.
- •Negative pregnancy test at Screening and at Baseline
- •Not be breastfeeding
- •For males of reproductive potential: use of condoms
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 192
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Diagnosis of smouldering or asymptomatic MM, plasmacell leukemia, solitary plasmocytoma of the bone o extramedullary plasmocytoma.
- •Diagnosis of non-secretory MM.
- •Patient not eligible for autologous transplant
- •Non-adequate organ function (kindneys, liver)
- •Previous allogeneic transplant
- •Concomitant enrollment in a clinical study
- •Concomitant use of a non authorized medication
- •Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14days prior to randomization
- •Known human immunodeficiency virus infection (HIV)
- •Active hepatitis A, B or C infection
- •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
- •DLCO <40%, TLC <40%, FEV1 <40% and/or receiving supplementary continuous oxygen
- •Non hematologic 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 as defined by National Cancer Institute Common Toxicity Criteria (NCI CTC) 4.0 (Appendix A)
- •Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and anti platelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
- •Pregnancy or breastfeeding
- •Unwillingness to use effective contraceptive measures up to 3 months after the end of study drug administration (females and males).
- •For Women at risk to become pregnant during study participation: positive test for pregnancy (serum) at the time of enrollment
研究者
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