此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT (DURGA-5)

2026年8月10日 更新者：AstraZeneca

Phase III Open-Label, Randomised Study of Consolidation With AZD0120 (Dual-Targeting BCMA/CD19 CAR-T) vs Continuous Standard Therapy in NDMM Patients Ineligible for ASCT as Initial Therapy (DURGA-5)

This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of standard induction regimens (IsaVRd and DRd) followed by AZD0120 versus standard induction regimens followed by continuous therapy (IsaRd and DRd) in participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT) as initial therapy.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

The primary objective is to demonstrate the superiority of IsaVRd or DRd induction followed by a single administration of AZD0120 compared to IsaVRd or DRd induction followed by continuous IsaRd or DRd in terms of progression-free survival (PFS) according to IMWG 2016 criteria, and as assessed by Blinded Independent Central Review (BICR) and miminal residual disease (MRD) negative complete response (CR) rate at 9 months post-randomisation in participants with NDMM who are ineligible to receive ASCT as initial therapy.

研究类型

介入性

注册 (估计的)

750

阶段

  • 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。

学习联系方式

学习地点

  • 丹麦
      • Århus N、丹麦、8200
        • 尚未招聘
        • Research Site
  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 5G2
        • 尚未招聘
        • Research Site
    • British Columbia
      • Vancouver、British Columbia、加拿大、V5Z 4E6
        • 尚未招聘
        • Research Site
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大、B3H 2Y9
        • 尚未招聘
        • Research Site
    • Ontario
      • Ottawa、Ontario、加拿大、K1H 8L6
        • 尚未招聘
        • Research Site
    • Quebec
      • Montreal、Quebec、加拿大、H1T 2M4
        • 尚未招聘
        • Research Site
      • Sherbrooke、Quebec、加拿大、J1G 2K7
        • 尚未招聘
        • Research Site
  • 台湾
      • Taipei、台湾、10002
        • 尚未招聘
        • Research Site
      • Taipei、台湾、112
        • 尚未招聘
        • Research Site
      • Taipei、台湾、106
        • 尚未招聘
        • Research Site
      • Taoyuan、台湾、33305
        • 尚未招聘
        • Research Site
  • 巴西
      • Salvador、巴西、41253-190
        • 尚未招聘
        • Research Site
      • São Paulo、巴西、05651-901
        • 尚未招聘
        • Research Site
      • São Paulo、巴西、01525-001
        • 尚未招聘
        • Research Site
  • 德国
      • Berlin、德国、13353
        • 尚未招聘
        • Research Site
      • Cologne、德国、50937
        • 尚未招聘
        • Research Site
      • Dresden、德国、01307
        • 尚未招聘
        • Research Site
      • Essen、德国、45122
        • 尚未招聘
        • Research Site
      • Freiburg im Breisgau、德国、79106
        • 尚未招聘
        • Research Site
      • Hamburg、德国、20246
        • 尚未招聘
        • Research Site
      • Kiel、德国、24105
        • 尚未招聘
        • Research Site
      • Leipzig、德国、04103
        • 尚未招聘
        • Research Site
      • Magdeburg、德国、39120
        • 尚未招聘
        • Research Site
      • Mainz、德国、55131
        • 尚未招聘
        • Research Site
      • München、德国、81675
        • 尚未招聘
        • Research Site
      • Nuremberg、德国、90419
        • 尚未招聘
        • Research Site
      • Würzburg、德国、97080
        • 尚未招聘
        • Research Site
  • 意大利
      • Bologna、意大利、40138
        • 尚未招聘
        • Research Site
      • Milan、意大利、20141
        • 尚未招聘
        • Research Site
      • Milan、意大利、20133
        • 尚未招聘
        • Research Site
      • Rome、意大利、00168
        • 尚未招聘
        • Research Site
      • Rozzano、意大利、20089
        • 尚未招聘
        • Research Site
      • Torino、意大利、10100
        • 尚未招聘
        • Research Site
  • 日本
      • Fukuoka、日本、812-8582
        • 尚未招聘
        • Research Site
      • Kyoto、日本、602-8566
        • 尚未招聘
        • Research Site
      • Nishinomiya-shi、日本、663-8501
        • 尚未招聘
        • Research Site
      • Okayama、日本、700-8558
        • 尚未招聘
        • Research Site
      • Sapporo、日本、060-8648
        • 尚未招聘
        • Research Site
      • Shibuya-ku、日本、150-8935
        • 尚未招聘
        • Research Site
      • Shinjuku-ku、日本、160-8582
        • 尚未招聘
        • Research Site
      • Suita-shi、日本、565-0871
        • 尚未招聘
        • Research Site
  • 法国
      • Lille、法国、59037
        • 尚未招聘
        • Research Site
      • Nantes、法国、44093
        • 尚未招聘
        • Research Site
      • Paris、法国、75010
        • 尚未招聘
        • Research Site
      • Poitiers、法国、86021
        • 尚未招聘
        • Research Site
      • Toulouse、法国、31059
        • 尚未招聘
        • Research Site
  • 波兰
      • Gdansk、波兰、80-952
        • 尚未招聘
        • Research Site
      • Gliwice、波兰、44-101
        • 尚未招聘
        • Research Site
      • Kielce、波兰、25-734
        • 尚未招聘
        • Research Site
      • Lublin、波兰、20-090
        • 尚未招聘
        • Research Site
      • Poznan、波兰、60-569
        • 尚未招聘
        • Research Site
      • Wroclaw、波兰、50-367
        • 尚未招聘
        • Research Site
  • 澳大利亚
      • Concord、澳大利亚、2139
        • 尚未招聘
        • Research Site
      • Darlinghurst、澳大利亚、2010
        • 尚未招聘
        • Research Site
      • East Melbourne、澳大利亚、3002
        • 尚未招聘
        • Research Site
      • Fitzroy、澳大利亚、VIC3065
        • 招聘中
        • Research Site
      • Liverpool、澳大利亚、2170
        • 尚未招聘
        • Research Site
      • Melbourne、澳大利亚、3004
        • 尚未招聘
        • Research Site
      • Murdoch、澳大利亚、6150
        • 尚未招聘
        • Research Site
      • Waratah、澳大利亚、2298
        • 尚未招聘
        • Research Site
  • 瑞典
      • Gothenburg、瑞典、413 45
        • 尚未招聘
        • Research Site
      • Huddinge、瑞典、141 57
        • 尚未招聘
        • Research Site
      • Lund、瑞典、22242
        • 尚未招聘
        • Research Site
  • 美国
    • Arizona
      • Gilbert、Arizona、美国、85234
        • 尚未招聘
        • Research Site
      • Phoenix、Arizona、美国、85054
        • 尚未招聘
        • Research Site
      • Tucson、Arizona、美国、85719
        • 尚未招聘
        • Research Site
    • California
      • Orange、California、美国、92868
        • 尚未招聘
        • Research Site
      • Santa Monica、California、美国、90404
        • 尚未招聘
        • Research Site
    • Colorado
      • Aurora、Colorado、美国、80045
        • 尚未招聘
        • Research Site
      • Denver、Colorado、美国、80218
        • 尚未招聘
        • Research Site
    • Connecticut
      • New Haven、Connecticut、美国、06510
        • 尚未招聘
        • Research Site
    • Florida
      • Coral Gables、Florida、美国、33156
        • 尚未招聘
        • Research Site
      • Tampa、Florida、美国、33606
        • 尚未招聘
        • Research Site
    • Georgia
      • Atlanta、Georgia、美国、30322
        • 尚未招聘
        • Research Site
    • Illinois
      • Chicago、Illinois、美国、60607
        • 尚未招聘
        • Research Site
    • Iowa
      • Iowa City、Iowa、美国、52242
        • 尚未招聘
        • Research Site
    • Kansas
      • Wichita、Kansas、美国、67214
        • 尚未招聘
        • Research Site
    • Kentucky
      • Louisville、Kentucky、美国、40207
        • 尚未招聘
        • Research Site
    • Louisiana
      • Baton Rouge、Louisiana、美国、70809
        • 尚未招聘
        • Research Site
    • Maryland
      • Baltimore、Maryland、美国、21201
        • 尚未招聘
        • Research Site
    • Michigan
      • Detroit、Michigan、美国、48201
        • 尚未招聘
        • Research Site
    • Missouri
      • St Louis、Missouri、美国、63110
        • 尚未招聘
        • Research Site
    • New Jersey
      • East Brunswick、New Jersey、美国、08816
        • 尚未招聘
        • Research Site
    • New York
      • Albany、New York、美国、12208
        • 尚未招聘
        • Research Site
      • New Hyde Park、New York、美国、11042
        • 尚未招聘
        • Research Site
      • New York、New York、美国、10029
        • 尚未招聘
        • Research Site
      • New York、New York、美国、10016
        • 尚未招聘
        • Research Site
      • New York、New York、美国、10032
        • 尚未招聘
        • Research Site
      • The Bronx、New York、美国、10467
        • 尚未招聘
        • Research Site
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • 尚未招聘
        • Research Site
      • Charlotte、North Carolina、美国、28203
        • 尚未招聘
        • Research Site
      • Durham、North Carolina、美国、27705
        • 尚未招聘
        • Research Site
      • Winston-Salem、North Carolina、美国、27157
        • 尚未招聘
        • Research Site
      • Winston-Salem、North Carolina、美国、27103
        • 尚未招聘
        • Research Site
    • Ohio
      • Cincinnati、Ohio、美国、45236
        • 尚未招聘
        • Research Site
      • Cleveland、Ohio、美国、44195
        • 尚未招聘
        • Research Site
      • Columbus、Ohio、美国、43210
        • 尚未招聘
        • Research Site
      • Montgomery、Ohio、美国、45242
        • 尚未招聘
        • Research Site
    • Oregon
      • Portland、Oregon、美国、97239
        • 尚未招聘
        • Research Site
    • Tennessee
      • Nashville、Tennessee、美国、37203
        • 尚未招聘
        • Research Site
      • Nashville、Tennessee、美国、37219
        • 尚未招聘
        • Research Site
    • Texas
      • Dallas、Texas、美国、75235
        • 尚未招聘
        • Research Site
      • Houston、Texas、美国、77030
        • 尚未招聘
        • Research Site
    • Virginia
      • Fairfax、Virginia、美国、22031
        • 尚未招聘
        • Research Site
    • Washington
      • Puyallup、Washington、美国、98373
        • 尚未招聘
        • Research Site
      • Seattle、Washington、美国、98104
        • 尚未招聘
        • Research Site
      • Seattle、Washington、美国、98101
        • 尚未招聘
        • Research Site
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • 撤销
        • Research Site
  • 英国
      • Edinburgh、英国、EH4 2XU
        • 尚未招聘
        • Research Site
      • London、英国、SE5 9RS
        • 尚未招聘
        • Research Site
      • Manchester、英国、M20 4BX
        • 尚未招聘
        • Research Site
  • 西班牙
      • Badalona、西班牙、8916
        • 尚未招聘
        • Research Site
      • Barcelona、西班牙、08036
        • 尚未招聘
        • Research Site
      • Madrid、西班牙、28007
        • 尚未招聘
        • Research Site
      • Madrid、西班牙、28041
        • 尚未招聘
        • Research Site
      • Pamplona、西班牙、31008
        • 尚未招聘
        • Research Site
      • Salamanca、西班牙、37007
        • 尚未招聘
        • Research Site
      • Seville、西班牙、41013
        • 尚未招聘
        • Research Site
      • Valencia、西班牙、46026
        • 尚未招聘
        • Research Site
  • 韩国
      • Seoul、韩国、3722
        • 尚未招聘
        • Research Site
      • Seoul、韩国、03080
        • 尚未招聘
        • Research Site
      • Seoul、韩国、06591
        • 尚未招聘
        • Research Site
      • Seoul、韩国、5505
        • 尚未招聘
        • Research Site
      • Seoul、韩国、06351
        • 尚未招聘
        • Research Site

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

INCLUSION CRITERIA:

  1. Participants must be 18 years or older, at the time of signing the ICF.
  2. Participant must have documented diagnosis of MM according to the IMWG diagnostic criteria.
  3. Participant must have one or more of the following measurable disease criteria: (a) Serum M-protein level ≥1.0 g/dL, (b) Urine M-protein level ≥ 200 mg/24 h, (c)Serum immunoglobulin FLC ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda FLC ratio.
  4. Participant must be deemed ineligible for ASCT while also having adequate organ function for CAR-T cell treatment.
  5. Participant is a candidate to receive at least one of the regimens (IsaVRd or DRd) as determined by the Investigator.
  6. ECOG performance status Grade of 0 to 2.
  7. Participant must have adequate organ and bone marrow function.

EXCLUSION CRITERIA:

  1. Participant has active or prior CNS or meningeal involvement of MM.
  2. Participant has primary amyloidosis, active plasma cell leukemia (≥5% circulating plasma cells), Waldenström macroglobulinemia, or POEMS syndrome.
  3. Participant has significant neurological or psychiatric condition posing risk or impairing evaluation.
  4. Participant has any other significant medical condition that increases unacceptable risk, interferes with therapy delivery, or confounds evaluation.
  5. Participant has a history of a prior non-haematologic malignancy unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years.
  6. Participant has a history of haematologic malignancies, other than MM, regardless of remission status.

  7. Participant is positive for any of the following:

    1. HIV: Known to be seropositive for HIV (including any history of HIV).
    2. Chronic or active hepatitis B.
    3. Active hepatitis C: Hepatitis C infection.
    4. Additional local requirements for the testing for infectious diseases and exclusions of applicable participants should be followed per local regulations.
  8. Participant has clinically significant cardiovascular disease.
  9. Participant has COPD with an FEV1 < 50% of predicted normal.
  10. Additional exclusion for participants who are planned to receive IsaVRd as induction: Participant has peripheral neuropathy Grade 4, Grade 3, Grade 2, or Grade 1 with pain.

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
干预/治疗
实验性的：Arm A: Investigational Arm
Arm A is the sequence of induction with IsaVRd or DRd, apheresis, optional bridging therapy, lymphodepletion (cyclophosphamide and fludarabine), and AZD0120.
药品：环磷酰胺
淋巴清除
药品：氟达拉滨
淋巴清除
生物：AZD0120
AZD0120, is a BCMA/CD19 dual CAR T-cell product, which is administered intravenously.
生物：Daratumumab
Induction, optional bridging and continuous therapy.
药品：Dexamethasone
Induction, optional bridging and continuous therapy.
生物：Isatuximab
Induction, optional bridging and continuous therapy.
药品：Lenalidomide
Induction, optional bridging and continuous therapy.
药品：Bortezomib
Induction therapy.
有源比较器：Arm B: Control Arm
Arm B is the standard therapy induction with IsaVRd or DRd, followed by continuous IsaRd or DRd until disease progression or intolerable toxicity.
生物：Daratumumab
Induction, optional bridging and continuous therapy.
药品：Dexamethasone
Induction, optional bridging and continuous therapy.
生物：Isatuximab
Induction, optional bridging and continuous therapy.
药品：Lenalidomide
Induction, optional bridging and continuous therapy.
药品：Bortezomib
Induction therapy.

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
PFS in NDMM who are ineligible to receive ASCT is measured to demonstrate the superiority of IsaVRd or DRd induction followed by AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd.
大体时间：Up to 9 years.
PFS: defined as time from randomisation until progression according to IMWG 2016 criteria as assessed by BICR, or death due to any cause, whichever occurs first.
Up to 9 years.
MRD negative CR rate at 9M in NDMM who are ineligible to receive ASCT is measured to demonstrate the superiority of IsaVRd or DRd induction followed by AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd
大体时间：Up to 9 years.
MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status (at threshold of 10-5) and have a response of CR or sCR (according to the IMWG 2016 criteria) as assessed by BICR at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.
Up to 9 years.

次要结果测量

结果测量
措施说明
大体时间
Complete Response Rate
大体时间：Up to 9 years.
The proportion of participants who achieved CR or better according to IMWG 2016 criteria, as assessed by BICR
Up to 9 years.
Overall Survival
大体时间：Up to 9 years.
Time from randomisation until date of death due to any cause
Up to 9 years.
Number and percentage of participants with adverse events as graded by CTCAE v6 and ASTCT Consensus Grading criteria
大体时间：Up to 9 years.
Adverse Event Incidence
Up to 9 years.
Concentration of Circulating CAR-T+ Cells in Peripheral Blood
大体时间：Up to 9 years.
Quantification of circulating CAR-T+ cell levels by measuring CAR transgene in peripheral blood and CK parameters of AZD0120 will be measured to characterise the cellular kinetics of AZD0120 in blood.
Up to 9 years.
Number and percentage of participants with incidence of ADAs against AZD0120
大体时间：Up to 9 years.
Assessment humoral immunogenicity of AZ0120 based on incidence of ADAs.
Up to 9 years.
Patient Reported Outcomes
大体时间：Up to 9 years.
Change from baseline in bone pain severity measured by the European Organisation for Research and Treatment of Cancer Item Library 469 single bone pain item (EORTC IL469 - score range 0 - 100, with higher scores indicating worse bone pain) in participants with newly diagnosed multiple myeloma ineligible for autologous stem cell transplantation as initial therapy.
Up to 9 years.
Patient Reported Outcomes
大体时间：Up to 9 years.
Change from baseline in fatigue severity, physical functioning, and global health status/quality of life measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 fatigue, physical functioning, and global health status/quality of life scales (EORTC QLQ-C30 - score range 0 to 100; higher scores indicate worse fatigue, better physical functioning, and better general health status/quality of life) in participants with newly diagnosed multiple myeloma ineligible for autologous stem cell transplantation as initial therapy.
Up to 9 years.
Overall Response Rate
大体时间：Up to 9 years
Proportion of participants who achieved PR or better according to IMWG 2016 criteria
Up to 9 years
Duration of Response
大体时间：Up to 9 years
Time from first documented confirmed response (PR or better) until date of documented PD per IMWG 2016 criteria or death due to any cause, whichever occurs first.
Up to 9 years
Time to Response
大体时间：Up to 9 years
Time from randomisation until the date of first documented objective response (PR or better), as assessed per IMWG 2016 criteria.
Up to 9 years
MRD negative CR rate
大体时间：Up to 9 years
Proportion of participants who have MRD negative status and have a response of CR or sCR (according to the IMWG 2016 criteria) at any time after the date of randomisation and before initiation of subsequent therapy.
Up to 9 years
Rate of sustained MRD negative CR
大体时间：Up to 9 years
Proportion of participants who have achieved MRD negative status and have a response of CR or sCR
Up to 9 years
Progression Free Survival 2 (PFS2)
大体时间：Up to 9 years
Time from randomisation to progression on next line of therapy, as assessed by Investigator, or death due to any cause, whichever occurs first
Up to 9 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。

赞助

AstraZeneca

调查人员

  • 研究主任：Jen Brudno, MD、AstraZeneca

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)

2026年6月26日

初级完成 (估计的)

2029年1月11日

研究完成 (估计的)

2034年5月12日

研究注册日期

首次提交

2026年7月1日

首先提交符合 QC 标准的

2026年8月10日

首次发布 (实际的)

2026年8月14日

研究记录更新

最后更新发布 (实际的)

2026年8月14日

上次提交的符合 QC 标准的更新

2026年8月10日

最后验证

2026年8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

  • D8312C00002

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD 共享时间框架

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD 共享访问标准

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

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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