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A Multicenter, Open-label, Phase 1b Study of Carfilzomib, Cyclophosphamide and Dexamethasone in Newly Diagnosed Multiple Myeloma Subjects (CHAMPION 2)

2017年4月28日 更新者：Amgen
The primary objective was to determine the maximum tolerated dose of carfilzomib given twice weekly in combination with cyclophosphamide and dexamethasone for patients with newly diagnosed multiple myeloma.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

22

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

  • 美国
    • California
      • Encinitas、California、美国
        • California Cancer Associates for Research and Excellence
      • West Hollywood、California、美国
        • James R. Berenson, MD
      • Whittier、California、美国
        • The Oncology Institute of Hope and Innovation
    • Indiana
      • Lafayette、Indiana、美国
        • Horizon Oncology Research
    • Maryland
      • Bethesda、Maryland、美国
        • Center For Cancer And Blood Disorders
    • New York
      • New York、New York、美国
        • Clinical Research Alliance
    • Tennessee
      • Nashville、Tennessee、美国
        • Tennessee Oncology
    • Texas
      • Austin、Texas、美国
        • Texas Oncology
    • Virginia
      • Norfolk、Virginia、美国
        • Virginia Oncology Associates

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

18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:

  1. Newly diagnosed multiple myeloma

  2. Measurable disease, as defined by 1 or more of the following

    • Serum M-protein ≥ 0.5 g/dL, or
    • Urine M-protein ≥ 200 mg/24 hours, or
    • In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal kappa lambda ( κ/λ) ratio
  3. Males and females ≥ 18 years of age
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  5. Adequate hepatic function
  6. Left ventricular ejection fraction (LVEF) ≥ 40%
  7. Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L
  8. Platelet count ≥ 50 × 10^9/L
  9. Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min

Exclusion Criteria:

  1. Planned autologous hematopoietic stem cell transplantation (HSCT) for the initial therapy of newly diagnosed multiple myeloma
  2. Multiple myeloma of immunoglobulin M (IgM) subtype
  3. Prior systemic treatment for multiple myeloma
  4. Glucocorticoid therapy within 14 days prior to enrollment that equals or exceeds the equivalent of dexamethasone 160 mg
  5. Known amyloidosis
  6. Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 6 months prior to enrollment.
  7. Known human immunodeficiency virus (HIV) seropositive, hepatitis C infection, and/or hepatitis B (subjects with hepatitis B surface antigen [SAg] or core antibody receiving and responding to antiviral therapy directed at hepatitis B are allowed)
  8. Significant neuropathy (Grades ≥ 2) within 14 days prior to enrollment
  9. Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent

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：Carfilzomib, Cyclophosphamide and Dexamethasone (CCd)
Participants received carfilzomib, cyclophosphamide and dexamethasone for up to eight 28-day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
药品：Carfilzomib
Carfilzomib administered as a 30-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. On Days 1 and 2 of Cycle 1, all participants received carfilzomib at 20 mg/m².
其他名称：
  • PR-171
  • PR171
  • 注射用 Kyprolis® (carfilzomib)
药品：Cyclophosphamide
Cyclophosphamide administered orally (PO) at the dose of 300 mg/m² on Days 1, 8, and 15 of each 28-day cycle.
药品：Dexamethasone
Dexamethasone administered PO or IV at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle.

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
Number of Participants With Dose-limiting Toxicities (DLTs)
大体时间：First cycle treatment over 28-days

The MTD is defined as the highest carfilzomib dose at which fewer than 33% of participants experience a treatment-related dose-limiting toxicity (DLT) during the first 28-day cycle. The number of participants who experienced a DLT is reported.

Dose-limiting toxicities are defined as any of the following carfilzomib-related adverse events:

Nonhematologic:

  • ≥ Grade 3 non-hematological toxicity
  • ≥ Grade 3 acute kidney injury (creatinine > 3 × baseline or > 4.0 mg/dL) lasting > 72 hours

Hematologic:

  • Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 10^9/L) lasting for > 7 days
  • Febrile neutropenia (ANC < 1.0 × 10^9/L with a fever ≥ 38.3ºC) of any duration
  • Grade 4 thrombocytopenia (< 25 × 10^9/L) that persists for > 14 days, despite holding treatment
  • Grade 3 or 4 thrombocytopenia associated with > Grade 1 bleeding
First cycle treatment over 28-days

次要结果测量

结果测量
措施说明
大体时间
Overall Response Rate (ORR)
大体时间：Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
Participants were evaluated for disease response and progression by the investigator according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). Disease response and progression assessments included serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), serum immunofixation, serum free light chain (SFLC), bone marrow sample (including fluorescent in situ hybridization [FISH]), plasmacytoma evaluation, and skeletal survey. Overall response rate is defined as the percentage of participants with a best response of stringent complete response, complete response, very good partial response (VGPR), or partial response.
Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
Time To Response (TTR)
大体时间：Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
Time to response is defined as months from treatment start to first documentation of response of partial response or better. Summary of time to response includes confirmed responders of PR or better only.
Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
Number of Participants With Adverse Events
大体时间：From first dose of study drug until 30 days after last dose; median duration of treatment was 31 weeks.

Adverse events (AEs) were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 and using the following scale:

Grade 1 = Mild, Grade 3 = Moderate; Grade 3 = Severe, Grade 4 = Life-threatening; Grade 5 = Fatal.
From first dose of study drug until 30 days after last dose; median duration of treatment was 31 weeks.

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

Amgen

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

2013年8月1日

初级完成 (实际的)

2016年3月1日

研究完成 (实际的)

2016年3月1日

研究注册日期

首次提交

2013年10月28日

首先提交符合 QC 标准的

2013年11月4日

首次发布 (估计)

2013年11月11日

研究记录更新

最后更新发布 (实际的)

2017年5月30日

上次提交的符合 QC 标准的更新

2017年4月28日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2012-003

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.

Carfilzomib的临床试验

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条件

罕见疾病

药物干预

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赞助者/合作者

地点

3
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