EUCTR2013-001432-22-FR进行中（未招募）1 期
A Multicenter Open label Phase II study of Pomalidomide and Cyclophosphamide and Dexamethasone in relapse/refractory Multiple Myeloma patients who were first treated within the IFM/DFCI 2009 trial - PCD
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
- 100
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 must have been treated in first line within the IFM/DFCI 2009 trial
- •2.Must be able to understand and voluntarily sign an informed consent form
- •3.Must be able to adhere to the study visit schedule and other protocol requirements
- •4.Age = 18 years
- •5.Life expectancy > 6 months
- •6.Patients must have symptomatic and progressive Myeloma as defined by the IMWG criteria
- •7.Patients must have a clearly detectable and quantifiable monoclonal M-component value
- •8.Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- •9.Adequate bone marrow function, documented within 96 hours prior to treatment without transfusion or growth factor support
- •10.Adequate organ function, documented within 96 hours prior to treatment.
- •11.Wash out period of at least 2 weeks from previous antitumor therapy or any investigational treatment.
- •12.Able to take antithrombotic medicines such as low molecular weight heparin or aspirin.
- •13.Subjects affiliated with an appropriate social security system
- •14.Agree to abstain from donating blood while taking study drug therapy and for at least 28 days following discontinuation of study drug therapy
- •15.Agree not to share study medication with another person and to return all unused study drug to the investigator
- •16.Female subjects of childbearing potential must:
- •- Understand the potential teratogenic risk to the unborn child
- •- Understand the need and agree to use, and be able to comply with, two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study:
- •1) for at least 28 days before starting study drug;
- •2) while participating in the study;
- •3) dose interruptions; and
- •4) for at least 28 days after study treatment discontinuation.
- •The two methods of reliable contraception must include one highly effective method and one additional effective (barrier) method. Females of childbearing potential must be referred to a qualified provider of contraceptive methods if needed.
- •17.Male subjects must:
- •- Practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.
- •- Agree not to donate semen or sperm during study drug therapy and for at least 28 days following discontinuation of study drug.
- •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 100
排除标准
- •1.Any other uncontrolled medical condition or comorbidity that might interfere with subject’s participation
- •2.Primary amyloidosis or myeloma complicated by amyloidosis
- •3.Pregnant or breast feeding females
- •4.Use of any other experimental drug or therapy within 2 weeks before study treatment initiation(except local radiotherapy and/or corticosteroid until dose of dexamethasone 160mg)
- •5.Known positive for HIV or Active infectious hepatitis, type B or C
- •6.Patients with non-secretory MM
- •7.Prior history of malignancies within 10 years
- •8.Evidence of Central Nervous System (CNS) involvement
- •9.Any > grade 2 toxicity unresolved
- •10.Peripheral neuropathy > grade 2
- •11.Known hypersensitivity to thalidomide, lenalidomide, cyclophosphamide or dexamethasone
- •12.Ongoing active infection, especially ongoing pneumonytis
- •13.Participant with clinical signs of heart or coronary failure, or evidence of Left Ventricular Ejection Fraction (LVEF) inferior to 40%.
- •Participant with myocardial infarction within 6 months prior to enrolment or have New York Heart Association (NYHA) Class III or IV heart failure, and controlled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- •14.Inability or unwillingness to comply with birth control requirements
- •15.Unable to take antithrombotic medicines at study entry
- •16.Unable to take corticotherapy at study entry
- •17.Individually deprived of liberty or placed under the authority of a tutor
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