EUCTR2007-001610-16-IT进行中（未招募）不适用
A PHASE 3, MULTICENTRE, RANDOMIZED, CONTROLLED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF LENALIDOMIDE, MELPHALAN AND PREDNISONE (MPR) versus MELPHALAN (200 mg/m2) FOLLOWED BY STEM CELL TRANSPLANT IN NEWLY DIAGNOSED MULTIPLE MYELOMA SUBJECTS - MPR vs MEL200
FONDAZIONE NEOPLASIE SANGUE ONLUS0 个研究点目标入组 380 人开始时间: 2007年6月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 380
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
- •? Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
- •? Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- •? Patient is 65 years old or younger at the time of signing the informed consent
- •? Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable double method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- •? Negative serum -human chorionic gonadotropin ( -HCG) pregnancy test both 24 hours prior to beginning of therapy and then at 4 weeks intervals in women with regular menstrual cycles or every 2 weeks in women with irregular menstrual cycles during study treatment for subjects of childbearing potential
- •? Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of lenalidomide therapy.
- •? Patient was diagnosed with symptomatic multiple myeloma based on standard criteria (9), and has measurable disease, defined as follows: any quantifiable serum monoclonal protein value (generally, but not necessarily, greater than 1 g/dL of IgG M-Protein and greater than 0.5 g/dL of IgA M-Protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours; measurable plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan); bone marrow plasma cells>10%.
- •? Patient has a Karnofsky performance status >= 60%.
- •? Patient has a life-expectancy > 6 months
- •? Patient has not active infectious hepatitis type B or C, and has HIV negative test
- •? Patients must have an ejection fraction by ECHO or MUGA > 50% performed within 60 days prior to registration
- •? Patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) > 50% of predicted. Patients unable to complete pulmonary function tests because of myeloma-related chest pain, must have a high resolution CT scan of the chest and must also have acceptable arterial blood gases defined as P02 greater than 70.
- •? Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cycle 1):
- •- Platelet count >= 75 x 109/L without transfusion support within 7 days before the test.
- •- Absolute neutrophil count (ANC) >= 1.5 x 109/L without the use of growth factors.
- •- Corrected serum calcium <= 14 mg/dL (3.5 mmol/L).
- •- Aspartate transaminase (AST): <= 2.5 x the upper limit of normal (ULN).
- •- Alanine transaminase (ALT): <= 2.5 x the ULN.
- •- Total bilirubin: <= 1.5 x the ULN.
- •- Calculated or measured creatinine clearance: >= 20 mL/minute
- •? Patient has a baseline bone marrow sample available for cytogenetics, that will be processed and eventually centralized within each country.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •? Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid; < to the equivalent of dexamethasone 40 mg/day for 4 days).
- •? Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study.
- •? Pregnant or lactating females.
- •? Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for >= 3 years. Exceptions include the following: Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
- •? Neuropathy of >= grade 2 severity.
- •? Patients previously diagnosed as bearing deep venous thrombosis or arterial thromboembolic event within the latest 6 months, or bearing a clear indication for anti-platelet or anticoagulant therapy or bearing a high risk of bleeding complications are ineligible for the sub-study protocol.
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