JPRN-jRCTs031190045已完成4 期
Effect of Daratumumab on Extramedullary Disease (EMD)in Patients with Refractory/Relapsed Multiple Myeloma
Inokuchi Koiti0 个研究点目标入组 1 人开始时间: 2019年6月26日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
研究概览
简要总结
Due to rare cases and reports of negative data, we decided to discontinue this study. In two patients with written informed consent, EMD was reduced with PR and the response was maintained for approxiamtely one year in one patient who was entered.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Relapse/refractory multiple myeloma currently with extramedullary disease
- •2) Extramedullary disease, defined as plasmacytoma outside bone marrow, has a single diameter of 2 cm or more than 2 cm and at least one measurable disease as follows
- •serum M-protein 0.5g/dL or or more than 0.5g/dL
- •urine M-protein 200 mg/24h or more than 200 mg/24h
- •serum free light chain (involved light chain) 100 mg/L or more than 100 mg/L
- •3) Normal organ function
- •absolute neutrophil count 1000/mm3 or more than 1000/mm3
- •platelet count 50,000/mm3 or more than 50,000/mm3
- •hemoglobin 8.0 g/dL or more than 8.0 g/dL
- •calculated creatinine clearance (using Cockcroft-Gault equation) 30 mL/min or more than 30 mL/min or Cr 3.0mg/dL or less than 3.0mg/dL
- •total bilirubin upper limit x 2 or or less than upper limit x 2
- •ALT, AST upper limit x 3 or or less than upper limit x 3
- •4) Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (including PS3 according bone diseases)
- •5) Patients who can comply the proper procedure of RevMate
- •6) Provide informed written consent
- •7) Willing to provide bone marrow and extramedullary samples for correlative research purposes
排除标准
- •1)pregnant or breastfeeding females
- •2)patients with other active neoplasm
- •3)patients who were previously treated with daratumumab
- •4)known active systemic infection
- •5)known hepatitis B surface antigen-positive status
- •6)known hepatitis C antibody-positive status
- •7)known human immunodeficiency virus (HIV) antibody-positive status
- •8)patients undergoing major surgery (except surgery for myeloma bone disease) within 14 days prior to the registration
- •9)patients undergoing radiation therapy within 7 days prior to the registration
- •10)evidence of current uncontrolled cardiovascular conditions including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
- •11)any serious medical or psychiatric illness that could, in the investigator's opinion,potentially interfere with the completion of treatment according to this protocol
研究者
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