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CKD-581 + Lenalidomide + Dexamethasone in Patients With Previously Treated Multiple Myeloma

2020年2月20日 更新者：Chong Kun Dang Pharmaceutical

A Phase I, Open-Label, Multi-Center Study of CKD-581 in Combination With Lenalidomide and Dexamethasone in Patients With Previously Treated Multiple Myeloma

This study is to determine the maximum tolerated dose(MTD) and recommened phase 2 dose(RP2D) based on dose limiting toxicity(DLT), and to evaluate safety and pharmacokinetics(PK) profile of a single agent CKD-581 injection in Combination with Lenalidomide and Dexamethasone in patients with Previously Treated Multiple Myeloma.

研究概览

地位

未知

条件

干预/治疗

详细说明

This is an open label, dose escalation study. Cohort of 3~6 patients receive escalation doses of CKD-516 until the maximum tolerated dose(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.

研究类型

介入性

注册 (预期的)

18

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 大韩民国
    • Gangnam-gu
      • Seoul、Gangnam-gu、大韩民国、06351
        • 招聘中
        • Samsung Hospital
        • 接触：
          • Ki Hyun Kim, PI
    • Seocho
      • Seoul、Seocho、大韩民国、06591
        • 招聘中
        • The Catholic University of Korea, Seoul St. Mary's Hospital
        • 接触：
          • Chang-ki Min, PI

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • must have received at least two prior lines of therapy and Diagnosis of symptomatic multiple myeloma(IMWG 2015)
  • Eastern Cooperative Oncology Group performance status ≤ 2
  • Life expectancy 12 weeks

  • must have the following laboratory values within 3 weeks prior to first dose of study drug

    • absolute neutrophil count(ANC) ≥ 1,500 mm3
    • platelet count(PLT)≥ 100,000 mm3
    • Hb ≥ 9.0g/dL
    • AST(SGOT) and ALT(SGPT) ≤ 3 x upper limit of normal(UNL)
    • Serum bilirubin ≤ 1.5 x ULN (but, Gilbert syndrome ≤ 3 x UNL)
    • Creatinin Clearance(CrCl) ≤ 50mL/min

  • One more measureable disease following values

    • Serum M-protein ≥ 1g/dL
    • Urine M-Protein ≥ 200mg/24hr
    • in that case serum M-protein, urine M-Protein nonmeasurable and FLC ratio abnormal, Serum free light chain(FLC) level ≥ 100mg/L(≥10mg/dL)
  • more than 24 weeks prior to last lenalidomide dose
  • must have signed the consent form

Exclusion Criteria:

  • Patients with CNS disease
  • Patients with clinically significant heart disease within 24weeks prior to first dose of study drug
  • patients with clinically significans abnormal EKG, echocardiography at screening
  • patients with patients with embolism within 24 weeks
  • patients with active hepatitis, HIV positive(exception, non active hepatitis)
  • peripheral neuropathy ≥ CTCAE grade 2 within 2 weeks prior to first dose of study drug
  • Patients with clinically significant disease
  • Patients with a prior malignancy with in the last 3 years except adequately treated basal cell or squamous cell or skin cancer, in situ cervical cancer
  • Patients who have received surgery, chemotherapy, radiation therapy or immunotherapy or any other investigational drugs ≤ 4 weeks prior to first dose of study drug and during treatment period
  • Patients who can not anticoagulate
  • Patients who have received dexamethasone >10mg/day within 2week prior to first dose of study drug and during treatment period
  • Women who are pregnant or breast feeding or women of childbearing potential not using an effective method of birth control. Male patients whose sexual partners are not using effective birth control.
  • patients with hypersensitive reaction of lenalidomide or dexamethasone

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Treat Regimen
CKD-581(investigational Drug) Lenalidomide Dexamethasone
药品：Treat Regimen
CKD-581(investigational Drug): on days 1, 8, 15 of repeated 28day cycles Lenalidomide: on days 1~21 of repeated 28 day cycles Dexamethasone: administrated once weekly every 28day cycles
其他名称：
  • CKD-581 lenalidomide dexamethasone regimen

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
MTD
大体时间：Up to 28 days(for 1st cycle)
Maximum Tolerated Dose
Up to 28 days(for 1st cycle)

次要结果测量

结果测量
措施说明
大体时间
Pharmacokinetics(Cmax)
大体时间：1st Cycle day1: up to 24hr
Pharmacokinetics
1st Cycle day1: up to 24hr

其他结果措施

结果测量
措施说明
大体时间
Objective Response Rate(ORR)
大体时间：Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly, up to 1year
Objective Response Rate(ORR) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks
Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly, up to 1year
Progression Free Survival(PFS)
大体时间：Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly, up to 1year
Progression Free Survival(PFS) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks
Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly, up to 1year
Overall Survival(OS)
大体时间：Average time period between the start day of induction therapy and the day of death, due to any cause, up to 1year
Overall Survival(OS) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks
Average time period between the start day of induction therapy and the day of death, due to any cause, up to 1year
Duration of Response(DOR)
大体时间：Average time period between the day of first achievement of response and the day of first relapse or progression, up to 1year
Duration of Response(DOR) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks
Average time period between the day of first achievement of response and the day of first relapse or progression, up to 1year
Pharmacokinetics(T1/2)
大体时间：1st Cycle day1: up to 24hr
Pharmacokinetics
1st Cycle day1: up to 24hr
Pharmacokinetics(CL)
大体时间：1st Cycle day1: up to 24hr
Pharmacokinetics
1st Cycle day1: up to 24hr
Pharmacokinetics(AUClast)
大体时间：1st Cycle day1: up to 24hr
Pharmacokinetics
1st Cycle day1: up to 24hr
Pharmacokinetics(AUCinf)
大体时间：1st Cycle day1: up to 24hr
Pharmacokinetics
1st Cycle day1: up to 24hr
Pharmacokinetics(Vd)
大体时间：1st Cycle day1: up to 24hr
Pharmacokinetics
1st Cycle day1: up to 24hr
Pharmacokinetics( MRT)
大体时间：1st Cycle day1: up to 24hr
Pharmacokinetics
1st Cycle day1: up to 24hr
Adverse events
大体时间：through study completion, an average of 1 year
Adverse events will be assessed using CTCAE criteria.
through study completion, an average of 1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Chong Kun Dang Pharmaceutical

调查人员

  • 首席研究员：Chanki Min、The Catholic University of Korea

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年5月10日

初级完成 (预期的)

2020年6月30日

研究完成 (预期的)

2021年9月30日

研究注册日期

首次提交

2017年5月10日

首先提交符合 QC 标准的

2017年5月10日

首次发布 (实际的)

2017年5月12日

研究记录更新

最后更新发布 (实际的)

2020年2月24日

上次提交的符合 QC 标准的更新

2020年2月20日

最后验证

2020年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 133MM16016

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

罕见疾病

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