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NCT07764978ClinicalTrials.gov

Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT

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)

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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…

שלב 3דרושים 750 משתתפים124 אתרים15 מדינות

קטגוריות

אונקולוגיה48%לב וכלי דם17%אימונולוגיה וראומטולוגיה17%המטולוגיה17%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered after enrolment began (about 49 days after the recorded start)First posted 2026-08-14; recorded start 2026-06-26
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 1019 other studies in this databaseCounted from the lead sponsor named in the record (AstraZeneca)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding0/20

    Open-label

  • Control arm15/15

    Active-comparator control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 124 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration3/5

    Registered within 30 days of the study start

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 750 participants (target), run at 124 sites, across 15 countries.

How this score is built
  • Enrolment28/40

    750 participants (target)

  • Site count23/25

    124 sites

  • Country count12/15

    15 countries

  • Planned duration10/10

    Planned over about 96 months

  • Sponsor scale10/10

    AstraZeneca has led 1,006 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

תקציר

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.

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.

מצבים רפואיים

  • Newly Diagnosed Multiple Myeloma

זכאות

מיןהכול
גילאים18 Years – ללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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.

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהNONE (0)
גיוסדרושים 750 משתתפים

נותן חסות ושותפים

  • AstraZeneca נותן חסות

זרועות והתערבויות

  • Arm A: Investigational ArmEXPERIMENTAL

    Arm A is the sequence of induction with IsaVRd or DRd, apheresis, optional bridging therapy, lymphodepletion (cyclophosphamide and fludarabine), and AZD0120.

  • Arm B: Control ArmACTIVE_COMPARATOR

    Arm B is the standard therapy induction with IsaVRd or DRd, followed by continuous IsaRd or DRd until disease progression or intolerable toxicity.

התערבויות

  • ביולוגי AZD0120

    AZD0120, is a BCMA/CD19 dual CAR T-cell product, which is administered intravenously.

  • תרופה Bortezomib

    Induction therapy.

  • תרופה Cyclophosphamide

    Lymphodepletion

  • ביולוגי Daratumumab

    Induction, optional bridging and continuous therapy.

  • תרופה Dexamethasone

    Induction, optional bridging and continuous therapy.

  • תרופה Fludarabine

    Lymphodepletion

  • ביולוגי Isatuximab

    Induction, optional bridging and continuous therapy.

  • תרופה Lenalidomide

    Induction, optional bridging and continuous therapy.

מדדי תוצאה

  1. מדד תוצאה ראשוני

    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.

    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.

    מסגרת זמן Up to 9 years.

  2. מדד תוצאה ראשוני

    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

    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.

    מסגרת זמן Up to 9 years.

  3. מדד תוצאה משני

    Complete Response Rate

    The proportion of participants who achieved CR or better according to IMWG 2016 criteria, as assessed by BICR

    מסגרת זמן Up to 9 years.

  4. מדד תוצאה משני

    Overall Survival

    Time from randomisation until date of death due to any cause

    מסגרת זמן Up to 9 years.

  5. מדד תוצאה משני

    Number and percentage of participants with adverse events as graded by CTCAE v6 and ASTCT Consensus Grading criteria

    Adverse Event Incidence

    מסגרת זמן Up to 9 years.

  6. מדד תוצאה משני

    Concentration of Circulating CAR-T+ Cells in Peripheral Blood

    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.

    מסגרת זמן Up to 9 years.

  7. מדד תוצאה משני

    Number and percentage of participants with incidence of ADAs against AZD0120

    Assessment humoral immunogenicity of AZ0120 based on incidence of ADAs.

    מסגרת זמן Up to 9 years.

  8. מדד תוצאה משני

    Patient Reported Outcomes

    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.

    מסגרת זמן Up to 9 years.

  9. מדד תוצאה משני

    Patient Reported Outcomes

    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.

    מסגרת זמן Up to 9 years.

  10. מדד תוצאה משני

    Overall Response Rate

    Proportion of participants who achieved PR or better according to IMWG 2016 criteria

    מסגרת זמן Up to 9 years

  11. מדד תוצאה משני

    Duration of Response

    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.

    מסגרת זמן Up to 9 years

  12. מדד תוצאה משני

    Time to Response

    Time from randomisation until the date of first documented objective response (PR or better), as assessed per IMWG 2016 criteria.

    מסגרת זמן Up to 9 years

  13. מדד תוצאה משני

    MRD negative CR rate

    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.

    מסגרת זמן Up to 9 years

  14. מדד תוצאה משני

    Rate of sustained MRD negative CR

    Proportion of participants who have achieved MRD negative status and have a response of CR or sCR

    מסגרת זמן Up to 9 years

  15. מדד תוצאה משני

    Progression Free Survival 2 (PFS2)

    Time from randomisation to progression on next line of therapy, as assessed by Investigator, or death due to any cause, whichever occurs first

    מסגרת זמן Up to 9 years

תאריכים

תאריך התחלה26 ביוני 2026 (בפועל)
סיום ראשוני11 בינואר 2029 (משוער)
סיום12 במאי 2034 (משוער)
פורסם לראשונה14 באוגוסט 2026 (בפועל)
עודכן לאחרונה14 באוגוסט 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהאוגוסט 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

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74 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

לא נרשמו שינויים מאז שקלטנו רשומה זו לראשונה.

שינוי נרשם בכל פעם שנותן החסות מעדכן את רשומת המרשם. מצב, תאריכים, גיוס ואתרים מופיעים כאן ככל שהם משתנים.

מרשם: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07764978