EUCTR2008-008599-15-CZ进行中（未招募）不适用
A PHASE 3, MULTICENTRE, RANDOMIZED, CONTROLLED STUDY TO DETERMINE THEEFFICACY AND SAFETY OF CYCLOPHOSPHAMIDE, LENALIDOMIDE AND DEXAMETHASONE (CRD) versus MELPHALAN (200 mg/m2) FOLLOWED BY STEM CELL TRANSPLANT IN NEWLY DIAGNOSED MULTIPLE MYELOMA SUBJECTS
FONDAZIONE NEOPLASIE SANGUE ONLUS0 个研究点目标入组 380 人开始时间: 2009年9月11日最近更新:
适应症
相关药物
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- •of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without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
- •-Women of child-bearing potential must agree to use 2 methods of contraception: 1 effective (for example
- •hormonal or tubal ligation) and 1 barrier (for example latex condom, diaphragm) for at least 4 weeks before
- •starting the therapy, during the Treatment Period, and for 4 weeks after the last dose of lenalidomide
- •-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.
- •-Negative serum B-human chorionic gonadotropin (B-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
- •-Patient was diagnosed with symptomatic multiple myeloma based on standard criteria (10), 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 more than 60%.
- •-Patient has a life-expectancy > 6 months -Patient has HBV, HCV and HIV negative
- •-Patients must have normal ECG and NYHA more than 2; an evaluation of ejection fraction by ECHO or MUGA
- •is optional -Patients must normal chest X ray; an evaluation of pulmonary function studies on mechanical aspects
- •(FEV1, FVC, etc) and diffusion capacity (DLCO) is optional.
- •-Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cycle 1): *Platelet
- •count more than 75 x 109/L without transfusion support within 7 days before the test. *Absolute neutrophil
- •count (ANC) 1.5x 109/L without the use of growth factors. *Corrected serum calcium more than 14 mg/dL
- •(3.5 mmol/L).*Aspartate transaminase (AST): more than 2.5 x the upper limit of normal (ULN). *Alanine
- •transaminase(ALT): more than 2.5 x the ULN. *Total bilirubin: more than1.5 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.
- •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 women. A serum b-hCG pregnancy test must be performed at the Screening visit, for
- •female patients of child-bearing potential. If the test is positive, the patient must be excluded from the study.
- •Confirmation that the patient is not pregnant must be established by a negative serum or urinary pregnancy test
- •with the result obtained 1 day prior to the Baseline visit (or the day of the visit if results are available before drug
- •delivery). A pregnancy test is not required for naturally post-menopausal women (who have not had menses
- •at any time in the preceding 24 consecutive months) or surgically sterilised women (hysterectomy, bilateral
- •ovariectomy, bilateral salpingectomy);
- •-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)
- •-Patients previously diagnosed as bearing deep venous thrombosis or arterial thromboembolic event within the
- •latest 12 months.
研究者
相似试验
进行中（未招募）
不适用
A PHASE 3, MULTICENTRE, RANDOMIZED, CONTROLLED STUDY TO DETERMINE THEEFFICACY AND SAFETY OF CYCLOPHOSPHAMIDE, LENALIDOMIDE AND DEXAMETHASONE (CRD) versus MELPHALAN (200 mg/m2) FOLLOWED BY STEM CELL TRANSPLANT IN NEWLY DIAGNOSED MULTIPLE MYELOMA SUBJECTSMultiple MyelomaEUCTR2008-008599-15-HUFONDAZIONE NEOPLASIE SANGUE ONLUS380
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 MEL200Patients with Multiple MyelomaMedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myelomaEUCTR2007-001610-16-ITFONDAZIONE NEOPLASIE SANGUE ONLUS380
进行中（未招募）
不适用
A PHASE 3, MULTICENTRE, RANDOMIZED, CONTROLLED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF CYCLOPHOSPHAMIDE, LENALIDOMIDE AND DEXAMETHASONE (CRD) versus MELPHALAN (200 mg/m2) FOLLOWED BY STEM CELL TRANSPLANT IN NEWLY DIAGNOSED MULTIPLE MYELOMA SUBJECTS - NDMultiple myelomaEUCTR2008-008599-15-ITFONDAZIONE NEOPLASIE SANGUE ONLUS380
进行中（未招募）
不适用
A PHASE 3, MULTICENTRE, RANDOMIZED, CONTROLLED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF CYCLOPHOSPHAMIDE, LENALIDOMIDE AND DEXAMETHASONE (CRD) versus MELPHALAN (200mg/m2) FOLLOWED BY STEM CELL TRANSPLANT IN NEWLY DIAGNOSED MULTIPLE MYELOMA SUBJECTS. - NAMULTIPLE MYELOMAEUCTR2008-008599-15-SKFONDAZIONE NEOPLASIE SANGUE ONLUS380
进行中（未招募）
1 期
CLINICAL STUDY FINALIZED TO DETERMINE THE EFFICACY AND SAFETY OF STANDARD TREATMENT WITH THE LENALIDOMIDE E DEXAMETHASONE DRUGS COMPARED WITH THE DOSE REDUCTIONS IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA THAT CAN NOT RECEIVE THE STANDARD CHEMIOTHERAPYELDERLY AND UNFIT NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTSMedDRA version: 18.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-004166-33-ITFO.NE.SA.Onlus200