EUCTR2014-000634-34-FR进行中（未招募）1 期
IFM 2014-02 study: A randomized phase III study of Bortezomib-Melphalan 200 conditioning regimen versus Melphalan 200 for frontline transplant eligible patients with multiple myeloma
CHU Toulouse0 个研究点目标入组 300 人开始时间: 2014年7月17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
- 300
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
入选标准
- •- Age = 18 years and = 65 years
- •- Must have results from their initial diagnosis available at the time of screening to confirm all the following :
- •1- Diagnosis of multiple myeloma according to the diagnostic criteria of the International Working Group plasma cell dyscrasias (Leukemia 2009)
- •2- Symptomatic de novo Multiple Myeloma with myeloma-related organ damage according to the CRAB criteria
- •3-Measurable disease requiring systemic treatment defined by a serum monoclonal protein = 5 g / l, urinary monoclonal protein = 200 mg/24 h or serum free light chains = 100 mg / l
- •- Be eligible for high-dose therapy with autologous stem cell transplantation.
- •- Autologous cell graft with a total number of CD 34 cells = 5 X 106/kg before freezing. A minimum of 2 x 106 CD34/kg is required
- •- LVEF > 40 %
- •- DLCO >50 %.
- •- ECOG performance status =2
- •- ALT = 3.5 times upper limit of normal and direct bilirubin = 2 mg / dL (34 µmol / L) within 14 days before enrollment
- •- eGFR = 40 mL / minute within 7 days prior to enrollment; MDRD formula should be used to calculate the creatinine clearance: http://mdrd.com/
- •- Voluntary written informed consent
- •- Women of childbearing potential must have a negative pregnancy test (serum or urine) before treatment start. They should take effective and acceptable method of contraception before treatment start, during treatment phase and up to 4 weeks after the last treatment administration. Women must also agree to perform iterative pregnancy tests during treatment.
- •- Men must agree not to conceive a child and agree to use a latex condom during the duration of treatment and for 4 weeks after the last treatment administration, even if they have undergone a successful vasectomy if their partner is of childbearing potential.
- •- Participants with social security insurance or equivalent social protection.
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Progressive disease
- •- Females participants pregnant or breast-feeding
- •- A known infection by the human immunodeficiency virus
- •- An active viral hepatitis B or C
- •- Unstable angina or myocardial infarction within 4 months prior to inclusion, heart failure NYHA class III or IV angina, uncontrolled, history of severe coronary artery disease, an uncontrolled serious ventricular arrhythmia, a sick sinus syndrome, or electrocardiographic evidence of acute ischemia or conduction disturbances grade 3 unless the patient has a pacemaker
- •- Uncontrolled hypertension or uncontrolled diabetes within 14 days before enrollment.
- •- A history of another malignancy. If cancer was diagnosed more than 10 years and considered as cured, an authorization may be requested on a case-by-case basis after discussion with the principal investigator.
- •- A significant neuropathy of grade 3-4 or grade 2 with pain in the 14 days prior to enrollment
- •- Known allergy to any of the study drugs, their analogs, or their excipients in their various formulations
- •- Known allergy to corticosteroids
- •- A contraindication to one drug or a required concomitant medication, including hypersensitivity to all anticoagulation and / or antiplatelet drugs, antiviral drugs
- •- Any other clinically significant disease that, in the opinion of the investigator, may interfere with adherence to the protocol or the patient's ability to give informed consent.
- •-Participant under juridical protection.
研究者
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