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比较来那度胺和皮下达雷妥尤单抗与来那度胺和地塞米松在既往未治疗的多发性骨髓瘤虚弱受试者中的疗效，这些受试者不适合高剂量治疗 (IFM2017_03)

2026年9月22日 更新者：University Hospital, Lille

一项比较来那度胺和皮下达雷妥尤单抗 (R-Dara SC) 与来那度胺和地塞米松 (Rd) 的 III 期研究，用于既往未接受过治疗的多发性骨髓瘤且不适合高剂量治疗的体弱受试者

This is a Phase 3, randomized (study drug assigned by chance), open-label (participants and researchers are aware about the treatment, participants are receiving), active-controlled (study in which the experimental treatment or procedure is compared to a standard treatment or procedure), parallel-group (each group of participants will be treated at the same time), and multicenter (when more than one hospital team work on a medical research study) study in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) and who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT). The primary hypothesis of this study is that subcutaneous Daratumumab in combination with Lenalidomide will prolong progression-free survival and likely induce less toxicity as compared with Lenalidomide and dexamethasone, in elderly frail subjects with newly diagnosed Multiple myeloma who are ineligible for high dose chemotherapy and ASCT

研究概览

地位

地位

指示当前招聘状态或扩展访问状态。
完全的

条件

条件

正在研究的疾病、紊乱、综合征、疾病或损伤。在 ClinicalTrials.gov 上，条件还可能包括其他与健康相关的问题，例如寿命、生活质量和健康风险。

干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。

详细说明

The primary hypothesis of this study is that subcutaneous Daratumumab in combination with Lenalidomide will prolong progression-free survival and likely induce less toxicity as compared with Lenalidomide and dexamethasone, in elderly frail subjects with newly diagnosed Multiple myeloma who are ineligible for high dose chemotherapy and ASCT

研究类型

研究类型

描述临床研究的性质。研究类型包括介入性研究（也称为临床试验）、观察性研究（包括患者登记）和扩展访问。
介入性

注册 (实际的)

注册

临床研究的参与者人数。 “预期”入组人数是研究人员进行研究所需的目标参与者人数。
294

阶段

阶段

根据美国食品和药物管理局 (FDA) 制定的定义，研究药物或生物制品的临床试验阶段。阶段基于研究的目标、参与者的数量和其他特征。有五个阶段：早期第 1 阶段（以前列为第 0 阶段）、第 1 阶段、第 2 阶段、第 3 阶段和第 4 阶段。不适用用于描述没有 FDA 定义的阶段的试验，包括设备试验或行为干预。
  • 第三阶段

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

  • 法国
      • Besançon、法国
        • Chru Jean Minjoz
      • Blois、法国
        • Ch Blois Simone Veil
      • Bourg-en-Bresse、法国
        • Ch Fleyriat
      • Brest、法国
        • Chru Brest Site Hopital Morvan
      • Caen、法国
        • Chu de Caen Normandie
      • Cesson-Sévigné、法国
        • Hopital Prive Sevigne - Cesson
      • Dijon、法国
        • Chu Dijon Bourgogne
      • Grenoble、法国
        • Chu de Grenoble
      • La Rochelle、法国
        • Gpe Hospitalier La Rochelle-Re-Aunis
      • Le Coudray、法国
        • Ch Chartres Louis Pasteur-Le Coudray
      • Lille、法国
        • Hôpital Claude Huriez, CHU
      • Marseille、法国
        • Institut Paoli Calmettes
      • Mont-de-Marsan、法国
        • Chi Mont de Marsan Et Pays Des Sources
      • Montpellier、法国
        • Chu Montpellier
      • Nantes、法国
        • Chu de Nantes Site Hotel Dieu Hme
      • Nice、法国
        • Chu de Nice Hopital de L'Archet
      • Pessac、法国、33604
        • Hopital Haut-Leveque - Chu
      • Périgueux、法国
        • Centre Hospitalier de Perigueux
      • Rennes、法国
        • Chru Rennes Site Pontchaillou
      • Saint-Quentin、法国
        • Centre Hospitalier de Saint Quentin
      • St-Malo、法国
        • Centre Hospitalier Saint-Malo
      • Toulouse、法国
        • Oncopole Chu Toulouse
      • Tours、法国
        • Chu de Tours

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

资格标准

想要参加临床研究的人必须满足的关键要求或他们必须具备的特征。资格标准包括纳入标准（一个人参与研究所必需的）和排除标准（阻止一个人参与）。资格标准的类型包括一项研究是否接受健康志愿者、是否有年龄或年龄组要求，或是否受性别限制。

适合学习的年龄

65年 及以上 (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. Subject must be at least 65 years of age.

  2. Subject must have documented multiple myeloma satisfying the CRAB criteria and measurable disease.

  3. Newly diagnosed and not considered candidate for high-dose chemotherapy with SCT.

  4. Subject must have a Frailty Score ≥ 2

  5. Subject must have within 5 days prior to first drug intake (C1D1) pretreatment clinical laboratory values meeting the following criteria during the Screening Phase:

    • hemoglobin ≥7.5 g/dL
    • absolute neutrophil count ≥1.0 x 109/L
    • platelet count ≥70 x 109/L
    • aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN)
    • alanine aminotransferase (ALT) ≤2.5 x ULN
    • total bilirubin ≤2.0 x ULN
    • creatinine clearance≥30mL/min

  6. Measurable ISS with β2-microglobulin and albumin values for randomization

  7. A man who is sexually active with a woman of childbearing potential must agree to use a latex or synthetic condom, even if they had a successful vasectomy. All men must also not donate sperm during the study, for 4 weeks after the last dose of lenalidomide, and for 4 months after the last dose of daratumumab. Women participating in this study must be postmenopausal.

  8. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the ICF.

  9. Subjects affiliated with an appropriate social security system.

Exclusion Criteria:

  1. Subject has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma.

  2. Subject has a diagnosis of Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.

  3. Subject has prior or current systemic therapy or SCT for multiple myeloma

  4. Subject has a history of malignancy (other than multiple myeloma) within 5 years before the date of randomization

  5. Subject has had radiation therapy within 14 days of randomization.

  6. Subject has had plasmapheresis within 28 days of randomization.

  7. Subject is exhibiting clinical signs of meningeal involvement of multiple myeloma.

  8. Subject has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume [FEV] in 1 second <60% of predicted normal), persistent asthma, or a history of asthma within the last 2 years (intermittent asthma is allowed).

  9. Subject is known to be seropositive for history of human immunodeficiency virus (HIV)

  10. Seropositive for hepatitis B.

  11. (Known to be) seropositive for hepatitis C

  12. Subject has any concurrent medical or psychiatric condition or disease that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study.

  13. Subject has clinically significant cardiac disease, including:

    • myocardial infarction within 1 year before randomization, or an unstable or uncontrolled disease/condition related to or affecting cardiac function
    • uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities
    • screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) >470 msec

  14. Subject has known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients

  15. Subject has plasma cell leukemia or POEMS syndrome

  16. Subject is known or suspected of not being able to comply with the study protocol. Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments.

  17. Subject has had major surgery within 2 weeks before randomization or has not fully recovered from surgery.

  18. Subject has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before randomization or is currently enrolled in an interventional investigational study.

  19. Refusal to consent or protected by legal regime ( guardianship, trusteeship)

  20. Subject has contraindications to required prophylaxis for deep vein thrombosis and pulmonary embolism

  21. Incidence of gastrointestinal disease that may significantly alter the absorption of oral drugs.

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：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂

参与者组/臂

根据试验方案，接受特定干预/治疗或不接受干预的临床试验参与者组或亚组。
干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。
实验性的：Arm 1: Experimental group

Daratumumab SC 1800 mg

  • once every week for 8 weeks
  • then once every other week for 16 weeks
  • thereafter once every 4 weeks, until progression Lenalidomide PO (25mg): days 1 through 21 of each 28-day cycle, until progression Dexamethasone PO (20mg): days 1, 8, 15, 22 of a 28-day cycle, for the first 2 cycles, then discontinued
药品：Daratumumab SC in combination with Lenalidomide

Daratumumab SC 1800 mg

  • once every week for 8 weeks
  • then once every other week for 16 weeks
  • thereafter once every 4 weeks, until progression
药品：Lenalidomide PO (25mg)

Lenalidomide PO (25mg): days 1 through 21 of each 28-day cycle, until progression

药品：Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression

Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression
假比较器：Arm 2: Control group

Lenalidomide PO (25mg): days 1 through 21 of each 28-day cycle, until progression Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression
药品：Lenalidomide PO (25mg)

Lenalidomide PO (25mg): days 1 through 21 of each 28-day cycle, until progression

药品：Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression

Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression

研究衡量的是什么？

主要结果指标

主要结果指标

在临床研究的方案中，对于评估干预/治疗的效果最重要的计划结果测量。大多数临床研究有一项主要结果指标，但有些研究有不止一项。
结果测量
措施说明
大体时间
Comparison of the efficacy of Daratumumab SC injection when combined with Lenalidomide (R-Dara SC) vs Lenalidomide and Dexamethasone (Rd): PFS
大体时间：From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months

The primary objective is to compare the efficacy of Daratumumab SC injection when combined with Lenalidomide (R-Dara SC) to that of Lenalidomide and Dexamethasone (Rd), in terms of PFS in frail subjects with newly diagnosed myeloma who are not candidates for high dose chemotherapy and autologous stem cell transplant.
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months

次要结果测量

次要结果测量

在临床研究的方案中，计划的结果测量值在评估干预效果时不如主要结果测量值重要，但仍然值得关注。大多数临床研究有不止一项次要结果指标。
结果测量
措施说明
大体时间
治疗失败时间
大体时间：从随机化日期到首次记录进展日期或毒性日期或任何原因死亡日期，以先到者为准，评估长达 84 个月
从随机化日期到首次记录进展日期或毒性日期或任何原因死亡日期，以先到者为准，评估长达 84 个月
下次治疗时间
大体时间：从随机化日期到首次记录进展日期或毒性日期或任何原因死亡日期，以先到者为准，评估长达 84 个月
从随机化日期到首次记录进展日期或毒性日期或任何原因死亡日期，以先到者为准，评估长达 84 个月
PFS2时间
大体时间：从随机化日期到首次记录进展日期或毒性日期或任何原因死亡日期，以先到者为准，评估长达 84 个月
从随机化日期到首次记录进展日期或毒性日期或任何原因死亡日期，以先到者为准，评估长达 84 个月
事件自由生存
大体时间：从随机化日期到首次记录进展日期或毒性日期或任何原因死亡日期，以先到者为准，评估长达 84 个月
从随机化日期到首次记录进展日期或毒性日期或任何原因死亡日期，以先到者为准，评估长达 84 个月
Overall survival (OS) time
大体时间：From date of randomization until the date of death from any cause, whichever came first, assessed up to 84months

Overall survival (OS) time,
From date of randomization until the date of death from any cause, whichever came first, assessed up to 84months
Complete remission (CR)
大体时间：From date of randomization until the date of first documented progression whichever came first, assessed up to 84months

Percentage of participants with CR, as defined by the IMWG criteria, will be reported.
From date of randomization until the date of first documented progression whichever came first, assessed up to 84months
Very good partial response (VGPR) or better.
大体时间：From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months

VGPR or better, defined as VGPR or CR according to the IMWG criteria during or after the study treatment at the time of data cutoff.
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Overall response (CR + VGPR + partial response [PR]).
大体时间：From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months

Overall response, defined as CR or VGPR or PR, according to the IMWG criteria
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Occurrence of grade 3 or more side effects.
大体时间：From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months

Collecting all AE (grade 3 or more)
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Safety and tolerability of Daratumumab SC when administered in combination with Revlimid: NCI-CTCAE V5.0.
大体时间：From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months

Evaluation of safety data by type, frequency, severity, relation to study drug, according to NCI-CTCAE V5.0.
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Evaluation of quality of life based on MY20 questionnaires
大体时间：From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months

Treatment effects on patient reported outcomes and heath economic/resource utilization.
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Evaluation of quality of life based on EORTC C30 questionnaires
大体时间：From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months

Treatment effects on patient reported outcomes and heath economic/resource utilization.
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Evaluation of quality of life based on EQ-5D questionnaires
大体时间：From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months

Treatment effects on patient reported outcomes and heath economic/resource utilization.
From date of randomization until the date of first documented progression or date of toxicity or date of death from any cause, whichever came first, assessed up to 84months
Minimal residual disease (MRD) negative rate at 12 months.
大体时间：after 12 months of treatment

Proportion of participants assessed as MRD negative
after 12 months of treatment

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

赞助

发起研究并有权和控制研究的组织或个人。
University Hospital, Lille

调查人员

调查人员

参与临床研究的研究人员。相关术语包括中心首席研究员、中心副研究员、研究主席、研究主管和研究首席研究员。
  • 首席研究员：Thierry Facon, MD,PhD、University Hospital, Lille

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。

一般刊物

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)

学习开始

第一位参与者参加临床研究的实际日期。 “预期”研究开始日期是研究人员认为将成为研究开始日期的日期。
2019年10月17日

初级完成 (实际的)

初级完成

临床研究的最后一名参与者接受检查或接受干预以收集主要结果测量的最终数据的日期。临床研究是否根据方案结束或被终止不影响该日期。对于具有多个不同完成日期的主要结果测量的临床研究，该术语是指完成所有主要结果测量的数据收集的日期。 “预期”主要完成日期是研究人员认为将成为研究主要完成日期的日期。
2026年8月28日

研究完成 (实际的)

研究完成

临床研究中最后一位参与者接受检查或接受干预/治疗以收集主要结局指标、次要结局指标和不良事件（即最后一位参与者的最后一次就诊）的最终数据的日期。 “预期”研究完成日期是研究人员认为将成为研究完成日期的日期。
2026年8月28日

研究注册日期

首次提交

首次提交

研究发起人或研究者首次向 ClinicalTrials.gov 提交研究记录的日期。在首次提交日期和记录在 ClinicalTrials.gov 上的可用性（首次发布日期）之间通常会有几天的延迟。
2019年5月27日

首先提交符合 QC 标准的

首先提交符合 QC 标准的

研究发起人或研究者首次提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录的日期。在满足 NLM 的 QC 审查标准之前，发起人或研究者可能需要修改和提交研究记录一次或多次。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2019年6月20日

首次发布 (实际的)

首次发布

在国家医学图书馆 (NLM) 质量控制 (QC) 审查结束后，研究记录首次在 ClinicalTrials.gov 上可用的日期。研究发起人或研究者提交研究记录的日期与首次发布日期之间通常会有几天的延迟。
2019年6月21日

研究记录更新

最后更新发布 (实际的)

最后更新发布

在 ClinicalTrials.gov 上提供研究记录更改的最近日期。研究发起人或研究者向 ClinicalTrials.gov 提交变更的时间（最后更新提交日期）和最后更新发布日期之间可能会有延迟。
2026年9月23日

上次提交的符合 QC 标准的更新

上次提交的符合 QC 标准的更新

研究发起人或研究者提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录更改的最近日期。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年9月22日

最后验证

最后验证

研究发起人或研究者确认 ClinicalTrials.gov 上的临床研究信息准确且最新的最近日期。如果一项研究的招募状态为招募；尚未招聘；或活跃，未在过去 2 年内确认招募，该研究的招募状态显示为未知。
2026年9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

其他研究编号

由研究的发起人、资助者或其他人分配给临床研究的标识符或 ID 号，而不是 NCT 号。这些编号可能包括来自其他试验登记处的唯一标识符和美国国立卫生研究院的资助编号。
  • 2018_16
  • 2018 (美国 NIH 拨款/合同)
  • 2018-003535-30 (EudraCT编号)

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

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