EUCTR2005-001554-24-BE进行中（未招募）不适用
INTERET D’UN TRAITEMENT D’ENTRETIEN PAR REVLIMID APRES AUTOGREFFE DE CELLULES SOUCHES CHEZ LES PATIENTS DE MOINS DE 65 ANS ATTEINTS DE MYELOME(Essai de phase III, multicentrique, randomisé, double aveugle, versus placebo) - IFM 2005-02
CHU de TOULOUSE0 个研究点目标入组 614 人开始时间: 2007年3月8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
- 614
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
- •4 - CRITERES D’ELIGIBILITE ET D’INCLUSION
- •4-1 - Selection
- •4-1 - 1 - pre-autograft Period
- •? novo Myeloma
- •? In stage DS: III, II, I with one symptomatic bone lesion (radiological)
- •? Age between 18 and 65 years
- •? Volunteer affiliated to a social security scheme
- •? No clinical signs of heart or coronary insufficiency and sonographic plane February> 40%.
- •? No liver injury bilirubin <35µmol / L and SGOT, SGPT, alkaline phosphatase less than 4 N.
- •? No respiratory failure: ventilatory tests and DLCO> 50% N.
- •? No previous renal disease not related to the disease and defined by a creatinine> 160 mmol / L.
- •? No history of another malignancy except basal cell carcinoma and stage of cervical cancer I.
- •? Serology HIV-
- •? Women of childbearing potential should have a serum or urine pregnancy test (done within 7 days before the start of treatment) negative. An effective method of contraception will also be used throughout the duration of treatment (oral contraceptives, injectable, transdermal or implantable, tubal ligation, IUD, contraceptive barrier using spermicides or partner's vasectomy).
- •4-1 - 2 - Period autograft
- •? Good general condition (WHO code 2; Appendix 2).
- •? creatinine <250 mmol / L.
- •? graft good quality according to the standards of each center (indicative = 5 X 106 CD34 / Kg / 1 for transplant)
- •? No other exclusion criteria (see diagnosis)
- •4-2 - Inclusion in the study (post-transplant randomization)
- •? Informed consent and patient's written
- •? post-transplant period = 6 months
- •? No signs of progression after transplantation (see Annex 3)
- •? Women of childbearing potential should have a serum pregnancy test (performed within 3 days before the start of treatment) negative. An effective method of contraception will also be used for the duration of maintenance therapy (oral contraceptives, injectable, transdermal or implantable, tubal ligation, IUD, contraceptive barrier using spermicides or partner's vasectomy). An additional method of birth control (condom) is highly recommended for the duration of treatment. Treatment should be delivered within 7 days after the completion of this test.
- •? No severe active infection
- •? satisfactory haematological reconstitution defined by: PN> 1000 / mm3 and Pads> 75,000 / mm3.
- •? Bilirubin <35 mmol / l and TGO / TGP / PAL <3N
- •? creatinine <160 mmol /
- •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
- •Cfr Inclusion Criteria
研究者
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