EUCTR2013-002157-29-ES进行中（未招募）1 期
Clinical, multicenter, single-arm, with a scheme of treatment with low doses of Bortezomib / Melphalan / Prednisone (Velcade) (MPV) in patients with multiple myeloma (MM) newly diagnosed symptomatic> = 75 years. - Velcadito
Ernesto Pérez Persona0 个研究点目标入组 44 人开始时间: 2014年8月14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
- 44
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
入选标准
- •- The patient should , in the investigator's opinion, be able to meet all
- •requirements of the trial.
- •- The patient must voluntarily sign informed consent before
- •performing any test study that is not part of routine care of
- •patients , with the knowledge that the patient can leave the
- •study at the time you want, without being harmed at any time their
- •- Age > 75 years
- •- The patient should be diagnosed symptomatic multiple myeloma according to
- •established criteria and may not have received any treatment for disease (see Appendix 6) . Administration is permitted steroid pulses some urgency required prior to starting treatment or induction administration of bisphosphonates .
- •- The patient must have measurable disease , defined as follows:
- •- For Multiple Myeloma secretory measurable disease is defined by the
- •presence of measurable serum monoclonal component, 1g/dL or if urinary excretion of light chains is greater than or equal to 200 mg/24 hours.
- •- For Multiple Myeloma oligosecretory or secretory , serous level chain
- •Free light affected 10 mg / dL (100 mg / L , with a ratio of abnormal free light chain serum)
- •- The patient must have a life expectancy greater than 3 months life.
- •- The patient must have the following laboratory values ??prior to initiation of treatment corresponding induction :
- •1. Platelet count 50000/mm3 , hemoglobin 8 g / dl , absolute neutrophil count 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 75
排除标准
- •-Patients who have previously received treatment for multiple myeloma, with the exception of pulse steroids for some urgency required prior to initiating induction therapy, administration of bisphosphonates or radiotherapy either analgesic or due to the presence of plasmacytomas required for some urgency.
- •Patients with non-measurable disease or by SFLC.
- •-Patients with known hypersensitivity to bortezomib, boron or mannitol acid.
- •-Patients who have received any investigational agent within 30 days prior to inclusion.
- •- Patients who are currently in another clinical trial or receiving any investigational agent.
- •- Poorly controlled hypertension or diabetes mellitus or other serious organic disease involving excessive risk to the patient or any psychiatric disorder that interfira with understanding of informed consent.
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