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AzTrials

Relapsed Refractory Multiple MyelomaPhase 3DURGA-4NCT07391657

A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)

A Phase 3 study testing AZD0120, Daratumumab and Carfilzomib in people with Relapsed Refractory Multiple Myeloma, run by AstraZeneca at 143 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard regimens (DKd [daratumumab, carfilzomib, and dexamethasone], DPd [daratumumab, pomalidomide, and dexamethasone], PVd [pomalidomide, bortezomib and dexamethasone], or Kd… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed Refractory Multiple Myeloma
What is being tested?
AZD0120, Daratumumab and Carfilzomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
508 participants
Where
143 sitesin 15 countries
Study dates
23 Feb 2026to 29 Jul 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria
  • Documented evidence of measurable disease:
  • Serum M-protein level ≥ 1 g/dL
  • Urine M-protein level ≥ 200 mg/24h
  • Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio
Show all 16Show fewer
  • Documented evidence of PD by IMWG 2016 criteria based on investigator's determination during or after the most recent line of therapy. Participants with only 1 prior line of therapy must have progressed within 47 months of a stem cell transplant, or if not transplanted, then within 42 months of starting initial therapy
  • Received 1 to 3 lines of prior therapy including an IMiD and either a PI or a CD38 antibody. Participant must have undergone at least 2 complete cycles of treatment for each line of therapy, unless PD was the best response to the line of therapy
  • Eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) as determined by the Investigator.
  • ECOG performance status score of 0 to 1
  • Adequate hematology and chemistry laboratory values:
  • Haemoglobin ≥ 8.0 g/dL
  • Absolute neutrophil count ≥ 1 × 10^9/L (1000 per mm3)
  • Platelet count ≥ 75 × 10^9/L (75000 per mm3) in participants with < 50% of bone marrow nucleated cells are plasma cells or ≥ 50 × 10^9/L (50000 per mm3) in participants with ≥ 50% of bone marrow nucleated cells are plasma cells
  • Absolute lymphocyte count ≥ 300/µL (0.3 × 109/L)
  • Total bilirubin ≤ 1.5 × ULN in the absence of Gilbert's syndrome or ≤ 3 × ULN if the participant has Gilbert's syndrome. AST and ALT≤ 3.0 × ULN. CrCl by Cockcroft and Gault method ≥ 30 mL/minute

Who cannot join

  • Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.
  • Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome.
  • Participants with primary refractory MM (failed to generate at least a minimal response to any prior therapy)
  • Significant neurological or psychiatric condition
  • Significant medical condition that places the participant at an unacceptable risk for treatment-related complications
  • Previously received any prior BCMA-targeted treatment
Show all 9Show fewer
  • Previously received CAR-T or CAR-NK therapy directed at any target
  • Previously received T-cell engager therapy directed at any target
  • Previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of randomization

Trial locations and contacts

143 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

143 sites in 15 countries

United States51 sites, 36 recruiting
  • Research Site

    Albany, New York, 12208

    Not yet recruiting
  • Research Site

    Atlanta, Georgia, 30322

    Recruiting
  • Research Site

    Austin, Texas, 78704

    Recruiting
  • Research Site

    Boston, Massachusetts, 02114

    Not yet recruiting
  • Research Site

    Boston, Massachusetts, 02215

    Not yet recruiting
  • Research Site

    Boston, Massachusetts, 02215

    Withdrawn
  • Research Site

    Chapel Hill, North Carolina, 27514

    Not yet recruiting
  • Research Site

    Charleston, South Carolina, 29425

    Withdrawn
  • Research Site

    Charlotte, North Carolina, 28204

    Not yet recruiting
  • Research Site

    Charlotte, North Carolina, 28204

    Recruiting
  • Research Site

    Charlottesville, Virginia, 22908

    Withdrawn
  • Research Site

    Chicago, Illinois, 60612

    Not yet recruiting
  • Research Site

    Cincinnati, Ohio, 45220

    Not yet recruiting
  • Research Site

    Cleveland, Ohio, 44195

    Not yet recruiting
  • Research Site

    Coral Gables, Florida, 33156

    Withdrawn
  • Research Site

    Dallas, Texas, 75235

    Not yet recruiting
  • Research Site

    Denver, Colorado, 80218

    Recruiting
  • Research Site

    Detroit, Michigan, 48201

    Withdrawn
  • Research Site

    Detroit, Michigan, 48202

    Withdrawn
  • Research Site

    Gainesville, Virginia, 20155

    Not yet recruiting
  • Research Site

    Gilbert, Arizona, 85234

    Not yet recruiting
  • Research Site

    Houston, Texas, 77030

    Recruiting
  • Research Site

    Iowa City, Iowa, 52242

    Withdrawn
  • Research Site

    Kansas City, Kansas, 66160

    Not yet recruiting
  • Research Site

    La Jolla, California, 92093

    Withdrawn
  • Research Site

    Louisville, Kentucky, 40207

    Recruiting
  • Research Site

    Madison, Wisconsin, 53792

    Not yet recruiting
  • Research Site

    Milwaukee, Wisconsin, 53226

    Recruiting
  • Research Site

    Nashville, Tennessee, 37203

    Recruiting
  • Research Site

    New Haven, Connecticut, 06510

    Recruiting
  • Research Site

    New York, New York, 10016

    Withdrawn
  • Research Site

    New York, New York, 10029

    Recruiting
  • Research Site

    New York, New York, 10065

    Withdrawn
  • Research Site

    New York, New York, 10065

    Recruiting
  • Research Site

    Park Ridge, Illinois, 60068

    Not yet recruiting
  • Research Site

    Phoenix, Arizona, 85054

    Withdrawn
  • Research Site

    Portland, Oregon, 97239

    Not yet recruiting
  • Research Site

    Puyallup, Washington, 98373

    Not yet recruiting
  • Research Site

    Richmond, Virginia, 23298

    Withdrawn
  • Research Site

    Rochester, Minnesota, 55905

    Withdrawn
  • Research Site

    Rochester, New York, 14642

    Withdrawn
  • Research Site

    Sacramento, California, 95817

    Not yet recruiting
  • Research Site

    Salt Lake City, Utah, 84112

    Not yet recruiting
  • Research Site

    Santa Monica, California, 90404

    Not yet recruiting
  • Research Site

    Seattle, Washington, 98104

    Recruiting
  • Research Site

    Tampa, Florida, 33606

    Not yet recruiting
  • Research Site

    The Bronx, New York, 10467

    Withdrawn
  • Research Site

    Tucson, Arizona, 85719

    Not yet recruiting
  • Research Site

    Washington D.C., District of Columbia, 20007

    Not yet recruiting
  • Research Site

    Winston-Salem, North Carolina, 27103

    Recruiting
  • Research Site

    Winston-Salem, North Carolina, 27157

    Not yet recruiting

Other trials in United States

China24 sites, 24 recruiting
  • Research Site

    Beijing, 100024

    Not yet recruiting
  • Research Site

    Beijing, 100044

    Not yet recruiting
  • Research Site

    Changchun, 130021

    Not yet recruiting
  • Research Site

    Changsha, 410008

    Not yet recruiting
  • Research Site

    Changsha, 410013

    Not yet recruiting
  • Research Site

    Chongqing, 400030

    Not yet recruiting
  • Research Site

    Guangzhou, 510000

    Not yet recruiting
  • Research Site

    Guangzhou, 510700

    Not yet recruiting
  • Research Site

    Hefei, 230601

    Not yet recruiting
  • Research Site

    Nanchang, 330000

    Not yet recruiting
  • Research Site

    Nanchang, 330006

    Not yet recruiting
  • Research Site

    Nanjing, 210000

    Not yet recruiting
  • Research Site

    Ningbo, 315040

    Not yet recruiting
  • Research Site

    Shanghai, 200025

    Not yet recruiting
  • Research Site

    Shanghai, 200065

    Not yet recruiting
  • Research Site

    Shanghai, 201210

    Not yet recruiting
  • Research Site

    Shenzhen, 518039

    Not yet recruiting
  • Research Site

    Tianjin, 300020

    Not yet recruiting
  • Research Site

    Wenzhou, 325000

    Not yet recruiting
  • Research Site

    Wuhan, 430030

    Not yet recruiting
  • Research Site

    Xi'an, 710004

    Not yet recruiting
  • Research Site

    Xi'an, 710061

    Not yet recruiting
  • Research Site

    Zhengzhou, 450000

    Not yet recruiting
  • Research Site

    Zhengzhou, 450008

    Not yet recruiting

Other trials in China

Germany11 sites, 11 recruiting
  • Research Site

    Berlin, 12200

    Not yet recruiting
  • Research Site

    Dresden, 01307

    Not yet recruiting
  • Research Site

    Erlangen, 91054

    Not yet recruiting
  • Research Site

    Essen, 45147

    Not yet recruiting
  • Research Site

    Freiburg im Breisgau, 79106

    Not yet recruiting
  • Research Site

    Hamburg, 20246

    Recruiting
  • Research Site

    Leipzig, 04103

    Not yet recruiting
  • Research Site

    Mainz, 55131

    Not yet recruiting
  • Research Site

    München, 81675

    Not yet recruiting
  • Research Site

    Nuremberg, 90419

    Not yet recruiting
  • Research Site

    Würzburg, 97080

    Not yet recruiting

Other trials in Germany

Australia7 sites, 7 recruiting
  • Research Site

    Camperdown, 2050

    Recruiting
  • Research Site

    Darlinghurst, 2010

    Recruiting
  • Research Site

    Fitzroy, VIC3065

    Recruiting
  • Research Site

    Liverpool, 2170

    Not yet recruiting
  • Research Site

    Melbourne, 3000

    Recruiting
  • Research Site

    Melbourne, 3004

    Recruiting
  • Research Site

    Murdoch, WA6150

    Not yet recruiting

Other trials in Australia

Spain7 sites, 7 recruiting
  • Research Site

    Barcelona, 08036

    Not yet recruiting
  • Research Site

    Barcelona, 8035

    Not yet recruiting
  • Research Site

    Madrid, 28041

    Recruiting
  • Research Site

    Pamplona, 31008

    Not yet recruiting
  • Research Site

    Salamanca, 37007

    Not yet recruiting
  • Research Site

    Santander, 39008

    Recruiting
  • Research Site

    Valencia, 46026

    Not yet recruiting

Other trials in Spain

France6 sites, 6 recruiting
  • Research Site

    Lille, 59037

    Not yet recruiting
  • Research Site

    Nantes, 44093

    Not yet recruiting
  • Research Site

    Paris, 75010

    Not yet recruiting
  • Research Site

    Pierre-Bénite, 69495

    Not yet recruiting
  • Research Site

    Poitiers, 86021

    Not yet recruiting
  • Research Site

    Toulouse, 31059

    Not yet recruiting

Other trials in France

Italy6 sites, 6 recruiting
  • Research Site

    Bologna, 40138

    Not yet recruiting
  • Research Site

    Milan, 20132

    Not yet recruiting
  • Research Site

    Milan, 20133

    Not yet recruiting
  • Research Site

    Naples, 80131

    Not yet recruiting
  • Research Site

    Rozzano, 20089

    Not yet recruiting
  • Research Site

    Torino, 10126

    Not yet recruiting

Other trials in Italy

Japan6 sites, 6 recruiting
  • Research Site

    Bunkyō City, 113-8431

    Recruiting
  • Research Site

    Kashiwa, 277-8577

    Recruiting
  • Research Site

    Kyoto, 602-8566

    Recruiting
  • Research Site

    Nagoya, 467-8602

    Recruiting
  • Research Site

    Shibuya-ku, 150-8935

    Recruiting
  • Research Site

    Shinjuku-ku, 160-8582

    Recruiting

Other trials in Japan

Poland6 sites, 6 recruiting
  • Research Site

    Gdansk, 80-952

    Not yet recruiting
  • Research Site

    Gliwice, 44-101

    Recruiting
  • Research Site

    Lublin, 20-090

    Not yet recruiting
  • Research Site

    Poznan, 60-569

    Not yet recruiting
  • Research Site

    Warsaw, 02-776

    Not yet recruiting
  • Research Site

    Wroclaw, 50-367

    Not yet recruiting

Other trials in Poland

Canada4 sites, 4 recruiting
  • Research Site

    Calgary, Alberta, T2N 5G2

    Not yet recruiting
  • Research Site

    Montreal, Quebec, H3A 1A1

    Recruiting
  • Research Site

    Toronto, Ontario, M5G 2M9

    Recruiting
  • Research Site

    Vancouver, British Columbia, V5Z 4E6

    Not yet recruiting

Other trials in Canada

South Korea4 sites, 4 recruiting
  • Research Site

    Seoul, 03080

    Not yet recruiting
  • Research Site

    Seoul, 06351

    Not yet recruiting
  • Research Site

    Seoul, 06591

    Not yet recruiting
  • Research Site

    Seoul, 5505

    Not yet recruiting

Other trials in South Korea

United Kingdom4 sites, 4 recruiting
  • Research Site

    Birmingham, B9 5SS

    Recruiting
  • Research Site

    Bristol, BS2 8ED

    Recruiting
  • Research Site

    Glasgow, Scotland, G12 0YN

    Not yet recruiting
  • Research Site

    London, SM2 5NG

    Recruiting

Other trials in United Kingdom

Brazil3 sites, 3 recruiting
  • Research Site

    Salvador, 41253-190

    Recruiting
  • Research Site

    São Paulo, 01509-900

    Recruiting
  • Research Site

    São Paulo, 05652-900

    Recruiting

Other trials in Brazil

Taiwan3 sites, 3 recruiting
  • Research Site

    Taipei, 10002

    Recruiting
  • Research Site

    Taipei, 106

    Recruiting
  • Research Site

    Taipei, 112

    Recruiting

Other trials in Taiwan

Norway1 site, 1 recruiting
  • Research Site

    Oslo, 0450

    Recruiting

Other trials in Norway

About this study

Official title: A Phase III Open-label, Randomised, Multicentre Study Comparing AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CART) Therapy Directed Against BCMA and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma.

This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard regimens (DKd [daratumumab, carfilzomib, and dexamethasone], DPd [daratumumab, pomalidomide, and dexamethasone], PVd [pomalidomide, bortezomib and dexamethasone], or Kd [carfilzomib and dexamethasone]) in participants with RRMM.

Keywords
BCMA, CAR-T, CD19
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07391657
Study groupRoleWhat they receive
Arm AExperimentalAZD0120
Receives: Biological: AZD0120
Arm BActive comparator1 of the following 4 standard regimens per investigator choice; DKd, DPd, PVd, Kd.
Receives: Drug: Daratumumab; Drug: Carfilzomib; Drug: Dexamethasone; Drug: Bortezomib; Drug: Pomalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of PFS in participants with RRMM.

    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.

    Measured: 3 years

  2. To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of MRD negativity rate at 9 months in participants with RRMM.

    MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status and have a response of CR or sCR (according to the IMWG 2016 criteria) at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.

    Measured: 2 years

Secondary outcomes (3)
  1. To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of CRR in participants with RRMM.

    Measured: 2 years

  2. To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of ORR in participants with RRMM.

    Measured: 2 years

  3. To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of OS in participants with RRMM.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2026
  2. Study start23 Feb 2026
  3. Primary completion14 Jun 2028 (estimated)
  4. Study completion29 Jul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open-label
Masking
None (open label)
Enrolment
508 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07391657
Sponsor's protocol ID
D8311C00001
Other IDs
AZD0120
Acronym
DURGA-4
Status last verified
Sep 2026
First submitted
30 Jan 2026
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AZD0120, Daratumumab and Carfilzomib in people with Relapsed Refractory Multiple Myeloma, run by AstraZeneca at 143 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 143 sites in United States, China, Germany, Australia, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of PFS in participants with RRMM. (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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