EUCTR2014-001330-29-ES进行中（未招募）不适用
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Ernesto Pérez Persona0 个研究点开始时间: 2014年10月16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
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
- •Patients must voluntarily sign informed consent before performing any test of study that is not part of routine care of patients.
- •Furthermore patients must be informed about the right of leaving the study at any moment and without detriment of subsequent care.
- •The patient must be diagnosed of symptomatic multiple myeloma according to established criteria.
- •Multiple myeloma with measurable disease at the time of relapse, according to the international criteria and for which doctor considers indicated the treatment with lenalidomide (25 mg / day) and dexamethasone (dexamethasone pulses or weekly dexamethasone).
- •At the time of relapse must have filed measurable disease defined as follows:
- •For secretory Multiple Myeloma measurable disease is defined by the presence of measurable monoclonal serum component superior or equal to 1 g / dL, or in urine when light chain excretion is superior or equal to 200 mg / 24 hours.
- •For oligo secretory or nonsecretory Multiple Myeloma, serum levels of free light chain
- •affected, superior or equal to 10 mg / dL (erior or equal to 100 mg / L, with a ratio of abnormal free light chain serum)
- •At the time of randomization the patient should be receiving a dose of lenalidomide superior or equal to 10 mg / day, at least 5 mg weekly dexamethasone.
- •Randomization was performed at the time it has reached maximum response with lenalidomide and dexamethasone, defined as follows:
- •· CR with negative IFE. Once objectified the RC, this should be confirmed at 8 weeks, during which time the patient will continue without change the dose of lenalidomide and
- •dexamethasone. That is, once RC is documented, patients receive two cycles of lenalidomide and dexamethasone until confirmation of the same.
- •· PR phase Plateau, defined as at least 3 months with a stable monoclonal component, and have completed at least one year of treatment with lenalidomide and dexamethasone.
- •The patient should have the following laboratory values ??prior to corresponding induction treatment initiation:
- •: Platelet count erior or equal to 50,000 / mm3, hemoglobin erior or equal to 8 g / dl and counting
- •absolute neutrophil erior or equal to 1000 / mm3. Lower values ??are permitted if they are due to infiltration of the MO
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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 30
排除标准
- •Patients in second or subsequent relapses. Patients may have received only treatment for newly diagnosed multiple myeloma. Is allowed at the time of relapse;
- •- steroid treatment pulses for some urgency required prior to initiating
- •second-line treatment,
- •-administration of bisphosphonates or antialgic radiotherapy due to the presence of plasmacytomas
- •Patients with non-measurable disease or by SFLC.
- •Patients with known hypersensitivity to lenalidomide.
- •Patients who have received any investigational agent within 30 days prior to enrollment.
- •Patients receiving doses below 10 mg / day of lenalidomide
- •Dexamethasone intolerant patients.
- •Patients who are currently in another clinical trial or receiving any investigational agent.
- •Hypertension or poorly controlled diabetes mellitus or other serious organic disease involving excessive risk to the patient or any psychiatric disorder interfering with the understanding of informed consent
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