NL-OMON50273招募中2 期
Carfilzomib and lenalidomide-based treatment for younger and elderly newly diagnosed primary plasma cell leukemia patients - HOVON 129 PC
HOVO0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Patients with diagnosis of symptomatic pPCL (see appendix A)
- •- Measurable disease as defined by the presence of M-protein in serum or urine
- •(serum M-protein > 10 g/l or urine M-protein > 200 mg/24 hours or abnormal FLC
- •ratio with involved free light chain (FLC) > 100 mg/l) or proven plasmacytoma
- •- Age >=18 years
- •- WHO-performance status 0-3 (but WHO=3 is allowed only when caused by pPCL
- •and not by co-morbid conditions)
- •- Written informed consent
- •- Patient capable of giving informed consent (patient is legally, physically
- •and mentally capable of giving consent)
- •- All men and women of childbearing potential should use adequate highly
- •effective contraception during the study. Men should be offered sperm banking
- •before starting treatment (if applicable).
- •- Negative pregnancy test at entry (if applicable)
- •- Patient is willing and able to adhere to the requirements of the
- •lenalidomide Pregnancy Prevention Program (PPP) throughout study treatment
排除标准
- •- Any current CNS involvement with disease refractory to intrathecal
- •chemotherapy.
- •- Female patients who are pregnant or breast feeding.
- •- HIV positive patients
- •- Active malignancy other than pPCL requiring treatment, or a malignancy that
- •has been treated with chemotherapy currently affecting bone marrow capacity
- •- Patients with active, uncontrolled infections
- •- Severe neurological or psychiatric disease
- •- Severe cardiac dysfunction (NYHA classification II-IV, see appendix E) -
- •Myocardial infarction within 6 months, unstable angina, and cardiac arrhythmias
- •which are not controlled by conventional treatment (including medications and
- •cardiac devices)
- •- Severe pulmonary dysfunction
- •- Significant hepatic dysfunction (serum bilirubin or transaminases >= 3.0 times
- •normal level), unless related to pPCL
- •- Patients with GFR < 15 ml/min
- •- Known history of allergy to Capsidol (a cyclodextrin derivative used to
- •solubilize carfilzomib)
- •- Hypersensitivity to the active substances or to any of the excipients of the
- •drug products
- •- Previous chemotherapy or radiotherapy except local radiotherapy in case of
- •local myeloma progression or corticosteroids maximum 7 days for symptom control
- •or stabilization(this includes dexamethasone 40 mg daily) or inthrathecal
- •chemotherapy in case of CNS involvement
- •- Systemic AL amyloidosis
- •- Any psychological, familial, sociological and geographical condition
- •potentially hampering compliance with the study protocol and follow-up schedule
研究者
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