EUCTR2012-001051-39-FI进行中（未招募）1 期
A prospective phase II study to assess immunophenotypic remission after three-drug in-duction followed by randomized stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance in patients with newly diagnosed multiple myeloma - First line treatment of myeloma with RVD, autologous stem cells and lenalidomide maintainance
Kuopio University Hospital, Clinic of Internal Medicine/Center of Medicine0 个研究点目标入组 80 人开始时间: 2012年9月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- •- Age 18 - 70 years
- •- Written informed consent
- •- Patients with a symptomatic, previously untreated, ISS 1-3 multiple myeloma
- •- Measurable disease: serum paraprotein > 10g/l or urine paraprotein > 200mg/24 hours or abnormal free light chain ratio
- •- WHO performance status 0-3 (if WHO 3, must be related to myeloma, not due to comor-bidities)
- •- Eligible for ASCT
- •- Sufficient renal function, glomerular filtration rate (GFR) assessed by Modification of Diet in Renal Disease formula (MDRD) > 15 ml/min unless on hemodialysis
- •- Women of childbearing potential (WCBP) must have a negative serum or urine preg-nancy test prior to starting lenalidomide. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, patches, or implantable hormonal contraceptive methods; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasecomized partner) while on lenalidomide. WCBP must agree to have pregnancy tests every 4 weeks while on lenalidomide.
- •- Males (including those who have had a vasectomy) must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with WCBP while on lenalidomide, when temporarily stopping lenalidomide and 28 days after the last dose of lenalidomide.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Previous chemotherapy or radiotherapy except local radiotherapy (10-20 Gy) or corticos-teroids maximum dexamethasone 160 mg in two weeks before study inclusion for symptom control
- •- Peripheral neuropathy grade = 2
- •- Contraindication to use of thromboembolic prophylaxis
- •- Significant hepatic dysfunction (serum bilirubin 3 x >ULN, transaminases = 2,5 x upper limit), unless related to myeloma
- •- Severe cardiac dysfunction
- •- Severe renal failure, GFR < 15ml/min, if not in hemodialysis
- •- Other serious medical or psychiatric illness
- •- Uncontrolled infection
- •- Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma
- •- Pregnancy
- •- Lactating women
- •- HIV-positive patients, HBsAg or HCV positive patients
- •- Primary plasma cell leukemia
- •- Systemic AL amyloidosis or myeloma associated amyloidosis if not eligible for ASCT
- •- Allogeneic stem cell transplantation planned
- •- Participants receiving any other investigational agents
- •- Participants with known brain metastases
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未知
2 期
DNK-651-3JPRN-jRCT2080223664DENKA SEIKEN CO.,LTD.500