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浆细胞骨髓瘤的来那度胺维持治疗

2026年9月24日 更新者:Memorial Sloan Kettering Cancer Center

This is a Phase 2 study to assess the good and bad effects of maintenance therapy on patients who have been treated for myeloma and no longer show signs of this type of cancer.

研究概览

地位

主动,不招人

研究类型

介入性

注册 (实际的)

108

阶段

  • 阶段2

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

    • New Jersey
      • Basking Ridge、New Jersey、美国
        • Memorial Sloan Kettering Cancer Center
      • Montvale、New Jersey、美国、07645
        • Memorial Sloan Kettering Bergen
    • New York
      • Commack、New York、美国、11725
        • Memorial Sloan Kettering Cancer Center @ Suffolk
      • Harrison、New York、美国、10604
        • Memorial Sloan Kettering Westchester
      • New York、New York、美国、10065
        • Memorial Sloan Kettering Cancer Center
      • Uniondale、New York、美国、11553
        • Memorial Sloan Kettering Nassau

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:

  • Patients with plasma cell myeloma treated with induction therapy or re-induction therapy, who at the time of study enrollment have documented evidence of stable disease response or better according to International Myeloma Workshop Consensus Panel

  • Age ≥18 years. Because no dosing or adverse event data are currently available on the use of lenalidomide in patients <18 years of age, children are excluded from this study, but may be eligible for future pediatric trials

  • ECOG performance status ≤ 2

  • Patient must have adequate hematologic, renal, and hepatic, and as defined by:

  • Absolute neutrophil count ≥ 1.0K /μL (growth factor support is permissible)

  • Platelets ≥ 75K/μL (transfusions are permissible)

  • Hemoglobin ≥ 8 g/dL (transfusions are permissible)

  • Creatinine clearance (CrCl) of greater than or equal to 40 mL/min. using the CKD-EPI formula (see Appendix C). If the CrCl based on the CKD-EPI formula is <40 mL/min, the patient will have a 24 hr urine collection to measure CrCl. The measured CrCl must also be ≥ 40 ml/min.

  • Total bilirubin ≤ 2 mg/dL, AST (SGOT) and ALT (SGPT) ≤ 3 x ULN

  • All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.

  • Females of childbearing potential* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days as required by Revlimid REMS®) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide.

    *A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months).

  • Females of childbearing potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.

  • Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy. See Appendix B: Lenalidomide Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.

  • Patients must be able to take daily prophylactic anticoagulation medication, such as: aspirin (81 or 325 mg) warfarin low molecular weight heparin or other medications as clinically indicated.

  • Patient must understand and voluntarily sign an informed consent form, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care.

Exclusion Criteria:

  • Patients with progressive or refractory plasma cell myeloma, as defined by International Myeloma Workshop Consensus Panel criteria.
  • Refractory to lenalidomide in the most recent line of therapy, as defined by the International Myeloma Consensus Panel criteria [47]- as failure to achieve minimal response or development of progressive disease while on lenalidomide or within 30 days of lenalidomide therapy
  • Patients who are receiving any other investigational agents with the intent to treat myeloma. Permitted concurrent therapies include:
  • Bisphosphonates
  • Plasma cell leukemia
  • Pregnant or breastfeeding females. Because there is a potential risk for adverse events to nursing infants secondary to treatment of the mother with lenalidomide, lactating females must agree not to breast feed while taking lenalidomide.
  • Uncontrolled hypertension or diabetes
  • Active hepatitis B or C infection
  • Diagnosed or treated for another malignancy within 3 years prior to study enrollment, with the exception of complete resection of non-melanoma skin cancer, or an in situ malignancy.
  • Previous diagnosis of another malignancy with any evidence of residual disease
  • Patients seropositive for the human immunodeficiency virus (HIV), and/or those who are taking anti-retroviral treatment for HIV/AIDS.
  • Prior organ transplant requiring immunosuppressive therapy
  • Prior allogeneic stem cell transplant
  • Patients requiring continuous, systemic immunosuppressive therapy
  • Patients with myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled cardiac arrhythmias, or electrocardiographic evidence of acute ischemia
  • Patients with conditions that would prevent absorption of the study drug
  • Uncontrolled intercurrent illness including but not limited to uncontrolled infection or psychiatric illness/social situations that would compromise compliance with study requirements
  • Significant neuropathy ≥Grade 3 at baseline
  • Contraindication to concomitant anticoagulation prophylaxis
  • Major surgery within 1 month prior to enrollment
  • Patients who were previously exposed and who developed severe adverse events, hypersensitivity or desquamating rash to either thalidomide or lenalidomide

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:Lenalidomide

Subjects will receive lenalidomide 10 mg by mouth daily on days 1-21 of a 28-day cycle. Subjects may continue lenalidomide until disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or the end of the study (5 years); whatever comes first. Patients who complete at least four cycles of treatment will be considered evaluable.

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
progression-free survival
大体时间:5 years

PFS is defined as time of start of treatment to time of progression or death, whichever occurs first.

5 years

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。

调查人员

  • 首席研究员:Alexander Lesokhin, MD、Memorial Sloan Kettering Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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)

2015年8月31日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年8月1日

研究注册日期

首次提交

2015年8月31日

首先提交符合 QC 标准的

2015年8月31日

首次发布 (估计的)

2015年9月2日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月24日

最后验证

2026年9月1日

更多信息

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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