EUCTR2011-001499-20-GR进行中（未招募）1 期
A phase II open label, non comparative, non randomized study for the assessment of the efficacy and safety of lenalidomide + adriamycine and low dose dexamethasone combination (RAD) in newly diagnosed, symptomatic multiple myeloma patients who are eligible for high dose therapy and autologous stem cell transplantation. - RAD
Meletios-Athanasios Dimopoulos0 个研究点开始时间: 2014年9月1日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Principal Inclusion Criteria
- •1-Subjects able to read and understand the Informed Consent Form.
- •2-Subjects must demonstrate their willingness to participate in the study and comply with its procedures.
- •3-Subjects who have signed the Informed Consent Form.
- •4-Newly diagnosed patients with symptomatic MM (Multiple Myeloma) according to the criteria of IMWG (International Myeloma Working Group).
- •5-Subjects eligible for autologous stem cell transplantation (?SCT).
- •6-Age 18-70 years, of either sex.
- •7-?arnofsky performance status = 60.
- •8-Platelet count = 100x109/L.
- •9-Neutrophil count = 1.5x109/L.
- •10-Serum ALT and AST = 3-fold of upper normal limit.
- •11-Serum bilirubin = 2-fold of upper normal limit.
- •12-Creatinine clearance =60 ml/min.
- •13-Expected survival = 6 months as per investigator’s clinical judgment.
- •14-Subjects able to tolerate aspirin, low molecular weight heparin or coumarinic agents as prophylactic anticoagulation.
- •15-Female subject of childbearing potential must have a negative serum pregnancy test (hCG) at Screening and if sexually active must be using a medically acceptable, highly effective, adequate form of birth control (ie, failure rate <1% per year when used consistently and correctly) prior to Screening and agree to continue using it while being in the study (Screening and Treatment Periods). Medically acceptable, highly effective forms of birth control are hormonal implants, oral contraceptives, medically acceptable prescribed intrauterine devices (IUDs), and monogamous relationship with a male partner who has had a vasectomy. Female subject who is not of childbearing potential must have a medical record of being surgically sterile (eg, hysterectomy, tubal ligation), or be at least 1 year. postmenopausal. Absence of menses for at least 1 year will indicate that a female is postmenopausal. A female subject should be encouraged to continue using a highly effective method of birth control for 30 days following the end of treatment.
- •16-A male subject must agree to use an adequate form of contraception for the duration of the study and agree to have sexual relations only with women who use a highly effective birth control method.
- •17-Subjects must be free of any clinically significant disease (other than MM) that would interfere with study evaluations.
- •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 43
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1-Women who are pregnant or breastfeeding or who intend to become pregnant during the trial.
- •2-Suspected or known hypersensitivity to any of the study treatment components.
- •3-Ongoing severe infection requiring intravenous antibiotic treatment.
- •4-Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in- situ cervical cancer, or other cancer from which the subject has been disease-free for at least 5 years. Concurrent prostate cancer for which the patient is receiving therapy will not be considered an exclusion if the PSA has been stable for three years.
- •5-Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia.
- •6-Myocardial infarction within 6 months before enrolment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
- •7-Uncontrolled medical problems such as diabetes mellitus, coronary artery disease, hypertension, unstable angina, arrhythmias, pulmonary, hepatic and renal diseases unless renal insufficiency is considered to be secondary to multiple myeloma.
- •8-Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •9-Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she will participate in the study or confounds the ability to interpret data from the study.
- •10-Subjects with any clinical condition that would affect study’s outcome according to physician’s discretion.
- •11-Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study.
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