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

August 10, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

750

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Cyclophosphamide
Lymphodepletion
Drug: Fludarabine
Lymphodepletion
Biological: AZD0120
AZD0120, is a BCMA/CD19 dual CAR T-cell product, which is administered intravenously.
Biological: Daratumumab
Induction, optional bridging and continuous therapy.
Drug: Dexamethasone
Induction, optional bridging and continuous therapy.
Biological: Isatuximab
Induction, optional bridging and continuous therapy.
Drug: Lenalidomide
Induction, optional bridging and continuous therapy.
Drug: Bortezomib
Induction therapy.
Active Comparator: 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.
Biological: Daratumumab
Induction, optional bridging and continuous therapy.
Drug: Dexamethasone
Induction, optional bridging and continuous therapy.
Biological: Isatuximab
Induction, optional bridging and continuous therapy.
Drug: Lenalidomide
Induction, optional bridging and continuous therapy.
Drug: Bortezomib
Induction therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate
Time Frame: 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
Time Frame: 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
Time Frame: Up to 9 years.
Adverse Event Incidence
Up to 9 years.
Concentration of Circulating CAR-T+ Cells in Peripheral Blood
Time Frame: 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
Time Frame: Up to 9 years.
Assessment humoral immunogenicity of AZ0120 based on incidence of ADAs.
Up to 9 years.
Patient Reported Outcomes
Time Frame: 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
Time Frame: 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
Time Frame: Up to 9 years
Proportion of participants who achieved PR or better according to IMWG 2016 criteria
Up to 9 years
Duration of Response
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Jen Brudno, MD, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2026

Primary Completion (Estimated)

January 11, 2029

Study Completion (Estimated)

May 12, 2034

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

August 10, 2026

First Posted (Actual)

August 14, 2026

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8312C00002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

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 Sharing Access Criteria

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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