EUCTR2008-000103-29-IT进行中（未招募）不适用
A single arm phase 2 study on the efficacy of Pegfilgrastim (Neulasta) after DCEP chemotherapy: a feasibility study in multiple myeloma patients eligible for autologous transplant. - ND
OSPEDALE POLICLINICO S. MATTEO0 个研究点开始时间: 2008年2月20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 candidates to autotransplant and responsive to debulking therapy
- •Age< 70 years; Absence of severe associated pulmonary, cardiac, metabolic, or concomitant neoplasia. written informed consent, ...
- •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
- •Diagnosis of smoldering myeloma or MGUS or Waldenstrom?s disease; Primary refractory patients to first-line therapy. Patients must have obtained at least a minimal response to first line therapy. HBV, HIV, HCV positive serology; Spleen size of ≥12 cm in the greatest dimension by splenic ultrasonography; Patients with prior history of pelvic radiotherapy for myeloma treatment; History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric disturbances; Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure (Appendix D, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis; Pregnancy or breastfeeding.
研究者
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