KCT0003345尚未招募未知
A phase II trial to evaluate the efficacy of daratumumab with DCEP in Multiply Myeloma patients with Plasmacytoma who fail to achieve complete remission with bortezomib containing induction regimen
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •?over 19 years old
- •?Patient is accompanied by a bone marrow extracellular cell that meets the diagnostic criteria of the International Myeloma Working Group multiple myeloma and is confirmed by a biopsy with a maximum diameter of at least 1 centimeter in computerized tomography or magnetic resonance imaging or Positron emission tomography-computed tomography at the time of scanning
- •?Patients who have failed to obtain Bortezomib-based induced cancer treatment after performing at least two cycles of Bortezomib-based therapy.
- •?Blood test indicates proper bone marrow and organ function
- •i.White blood cells =3000
- •ii.Absolute neutrophil count =1500
- •iii.Platelets =50,000 (In case of a bone marrow transfer, it is allowed to register after improvement through the use of dexamethasone 10 mg 4 day. No blood transfusions are allowed within two weeks)
- •iv.Hemoglobin >7.5mg/dL (No blood transfusions are allowed within two weeks)
- •v.Total bilirubin <1.5 times upper limit of normal
- •vi.Aspartate aminotransferase and Alanine aminotransferase <1.5 times upper limit of normal
- •vii.Serum creatinine <1.5 times upper limit of normal
- •?Understand the content of the study statement and agree voluntarily in writing.
- •?Will and ability to comply with visit schedules, treatment plans, laboratory testing and other test procedures.
- •?A fertile woman must agree to use very effective contraception during the test period and for 30 days after the last DCEP dose or for three months after the last dose of Daratumumab
- •?Male with fertile women must have received condoms during the treatment period of Dexamethasone , Cyclophosphamide, Etoposdie, Cisplatin / Daratumumumab and for an additional 90 days after the last dose of Dexamethasone , Cyclophosphamide, Etoposdie, Cisplatin / Daratumumab and have been medically successful..
- •?Male must agree to never donate sperm during treatment and for an additional 90 days after the last dose of Dexamethasone , Cyclophosphamide, Etoposdie, Cisplatin / Daratumumab.
排除标准
- •? In case self- or homogenous hematopoietic stem cell transplants are performed within 12 weeks to treat multiple myeloma
- •?In case of using immunodeficiency drugs for multiple myeloma, chemotherapy or radiotherapy for extrasolar cells within two weeks.
- •? High-capacity steroids used in relation to clinical symptoms,
- •(However, a total of 40 mg or less is permitted to be used in order to improve blood loss symptoms including platelets reduction.)
- •? If previously treated with DCEP regimen (Except if used for mobilization)
- •? When there was a central nervous system invasive at the point of entry into the diagnosis or study
- •?If there are symptoms of myocardial infarction, cerebral infarction, cerebral hemorrhage, or uncontrolled angina within six months, then new York Heart Association (New York Heart Association Class III or IV)
- •? In case there is an unregulated dynamic pulley discharge (COPD) or continuous asthma history within 6 months
- •? In case other malignant tumors were diagnosed in the last five years other than multiple myeloma.
- •However, it excludes flat epithelial cell cervical cancer and skin cancer, which do not have a history of chemotherapy after complete local control.
- •? Person who has an overreaction to a test drug or who is a taboo
- •? In case of an uncontrolled infection or organ failure
- •? Creatinine Clearance <25mL/min
- •? In case of congenital immune disease or acquired immune deficiency syndrome
- •? Pregnant or nursing women
- •? In the past, if you have been treated for a daratumb or other ani-CD38
- •? In case of HIV(human immunodeficiency virus) positive, who have Active HBV, Active HCV infection
- •16 For patients with CTCAE grade 2 or higher toxicity and neuropathy above grade 2 that are not addressed by previous chemotherapy, the assessment of the subject disease is conducted after the researcher's medical advice.
研究者
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