Newly Diagnosed Multiple MyelomaPhase 3DURGA-5NCT07764978

Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT

A Phase 3 study testing AZD0120, Daratumumab and Dexamethasone in people with Newly Diagnosed Multiple Myeloma, run by AstraZeneca at 124 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

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Newly Diagnosed Multiple Myeloma
What is being tested?: AZD0120, Daratumumab and Dexamethasone
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 750 participants
Where: 124 sitesin 15 countries
Study dates: 26 Jun 2026to 12 May 2034
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

Participants must be 18 years or older, at the time of signing the ICF.
Participant must have documented diagnosis of MM according to the IMWG diagnostic criteria.
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.
Participant must be deemed ineligible for ASCT while also having adequate organ function for CAR-T cell treatment.
Participant is a candidate to receive at least one of the regimens (IsaVRd or DRd) as determined by the Investigator.
ECOG performance status Grade of 0 to 2.
Participant must have adequate organ and bone marrow function.

Who cannot join

Participant has active or prior CNS or meningeal involvement of MM.
Participant has primary amyloidosis, active plasma cell leukemia (≥5% circulating plasma cells), Waldenström macroglobulinemia, or POEMS syndrome.
Participant has significant neurological or psychiatric condition posing risk or impairing evaluation.
Participant has any other significant medical condition that increases unacceptable risk, interferes with therapy delivery, or confounds evaluation.
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.
Participant has a history of haematologic malignancies, other than MM, regardless of remission status.

Show all 14Show fewer

Participant is positive for any of the following:
HIV: Known to be seropositive for HIV (including any history of HIV).
Chronic or active hepatitis B.
Active hepatitis C: Hepatitis C infection.
Additional local requirements for the testing for infectious diseases and exclusions of applicable participants should be followed per local regulations.
Participant has clinically significant cardiovascular disease.
Participant has COPD with an FEV1 < 50% of predicted normal.
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.

Trial locations and contacts

124 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

Country

City, postcode or hospital

Sites recruiting now only

124 sites in 15 countries

United States45 sites, 44 recruiting

Research Site
Albany, New York, 12208
Not yet recruiting
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Atlanta, Georgia, 30322
Not yet recruiting
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Aurora, Colorado, 80045
Not yet recruiting
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Baltimore, Maryland, 21201
Not yet recruiting
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Baton Rouge, Louisiana, 70809
Not yet recruiting
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Chapel Hill, North Carolina, 27599
Not yet recruiting
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Charlotte, North Carolina, 28203
Not yet recruiting
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Chicago, Illinois, 60607
Not yet recruiting
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Cincinnati, Ohio, 45236
Not yet recruiting
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Cleveland, Ohio, 44195
Not yet recruiting
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Columbus, Ohio, 43210
Not yet recruiting
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Coral Gables, Florida, 33156
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Dallas, Texas, 75235
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Denver, Colorado, 80218
Not yet recruiting
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Detroit, Michigan, 48201
Not yet recruiting
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Durham, North Carolina, 27705
Not yet recruiting
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East Brunswick, New Jersey, 08816
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Fairfax, Virginia, 22031
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Gilbert, Arizona, 85234
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Houston, Texas, 77030
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Iowa City, Iowa, 52242
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Louisville, Kentucky, 40207
Not yet recruiting
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Milwaukee, Wisconsin, 53226
Withdrawn
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Montgomery, Ohio, 45242
Not yet recruiting
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Nashville, Tennessee, 37203
Not yet recruiting
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Nashville, Tennessee, 37219
Not yet recruiting
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New Haven, Connecticut, 06510
Not yet recruiting
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New Hyde Park, New York, 11042
Not yet recruiting
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New York, New York, 10016
Not yet recruiting
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New York, New York, 10029
Not yet recruiting
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New York, New York, 10032
Not yet recruiting
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Orange, California, 92868
Not yet recruiting
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Phoenix, Arizona, 85054
Not yet recruiting
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Portland, Oregon, 97239
Not yet recruiting
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Puyallup, Washington, 98373
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Santa Monica, California, 90404
Not yet recruiting
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Seattle, Washington, 98101
Not yet recruiting
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Seattle, Washington, 98104
Not yet recruiting
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St Louis, Missouri, 63110
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Tampa, Florida, 33606
Not yet recruiting
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The Bronx, New York, 10467
Not yet recruiting
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Tucson, Arizona, 85719
Not yet recruiting
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Wichita, Kansas, 67214
Not yet recruiting
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Winston-Salem, North Carolina, 27103
Not yet recruiting
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Winston-Salem, North Carolina, 27157
Not yet recruiting

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Germany13 sites, 13 recruiting

Research Site
Berlin, 13353
Not yet recruiting
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Cologne, 50937
Not yet recruiting
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Dresden, 01307
Not yet recruiting
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Essen, 45122
Not yet recruiting
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Freiburg im Breisgau, 79106
Not yet recruiting
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Hamburg, 20246
Not yet recruiting
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Kiel, 24105
Not yet recruiting
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Leipzig, 04103
Not yet recruiting
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Magdeburg, 39120
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Mainz, 55131
Not yet recruiting
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München, 81675
Not yet recruiting
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Nuremberg, 90419
Not yet recruiting
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Würzburg, 97080
Not yet recruiting

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Australia8 sites, 8 recruiting

Research Site
Concord, 2139
Not yet recruiting
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Darlinghurst, 2010
Not yet recruiting
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East Melbourne, 3002
Not yet recruiting
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Fitzroy, VIC3065
Recruiting
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Liverpool, 2170
Not yet recruiting
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Melbourne, 3004
Not yet recruiting
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Murdoch, 6150
Not yet recruiting
Research Site
Waratah, 2298
Not yet recruiting

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Japan8 sites, 8 recruiting

Research Site
Fukuoka, 812-8582
Not yet recruiting
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Kyoto, 602-8566
Not yet recruiting
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Nishinomiya-shi, 663-8501
Not yet recruiting
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Okayama, 700-8558
Not yet recruiting
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Sapporo, 060-8648
Not yet recruiting
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Shibuya-ku, 150-8935
Not yet recruiting
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Shinjuku-ku, 160-8582
Not yet recruiting
Research Site
Suita-shi, 565-0871
Not yet recruiting

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Spain8 sites, 8 recruiting

Research Site
Badalona, 8916
Not yet recruiting
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Barcelona, 08036
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Madrid, 28007
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Madrid, 28041
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Pamplona, 31008
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Salamanca, 37007
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Seville, 41013
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Valencia, 46026
Not yet recruiting

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Canada6 sites, 6 recruiting

Research Site
Calgary, Alberta, T2N 5G2
Not yet recruiting
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Halifax, Nova Scotia, B3H 2Y9
Not yet recruiting
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Montreal, Quebec, H1T 2M4
Not yet recruiting
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Ottawa, Ontario, K1H 8L6
Not yet recruiting
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Sherbrooke, Quebec, J1G 2K7
Not yet recruiting
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Vancouver, British Columbia, V5Z 4E6
Not yet recruiting

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Italy6 sites, 6 recruiting

Research Site
Bologna, 40138
Not yet recruiting
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Milan, 20133
Not yet recruiting
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Milan, 20141
Not yet recruiting
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Rome, 00168
Not yet recruiting
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Rozzano, 20089
Not yet recruiting
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Torino, 10100
Not yet recruiting

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Poland6 sites, 6 recruiting

Research Site
Gdansk, 80-952
Not yet recruiting
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Gliwice, 44-101
Not yet recruiting
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Kielce, 25-734
Not yet recruiting
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Lublin, 20-090
Not yet recruiting
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Poznan, 60-569
Not yet recruiting
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Wroclaw, 50-367
Not yet recruiting

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France5 sites, 5 recruiting

Research Site
Lille, 59037
Not yet recruiting
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Nantes, 44093
Not yet recruiting
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Paris, 75010
Not yet recruiting
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Poitiers, 86021
Not yet recruiting
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Toulouse, 31059
Not yet recruiting

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South Korea5 sites, 5 recruiting

Research Site
Seoul, 03080
Not yet recruiting
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Seoul, 06351
Not yet recruiting
Research Site
Seoul, 06591
Not yet recruiting
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Seoul, 3722
Not yet recruiting
Research Site
Seoul, 5505
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Taipei, 112
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Research Site
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Gothenburg, 413 45
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Huddinge, 141 57
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Research Site
Lund, 22242
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United Kingdom3 sites, 3 recruiting

Research Site
Edinburgh, EH4 2XU
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Research Site
London, SE5 9RS
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Research Site
Manchester, M20 4BX
Not yet recruiting

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Denmark1 site, 1 recruiting

Research Site
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About this study

Official title: 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)

Read the 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.

Conditions: Newly Diagnosed Multiple Myeloma
Being tested: AZD0120, Daratumumab, Dexamethasone, Isatuximab, Lenalidomide
Keywords: Newly Diagnosed Multiple Myeloma (NDMM), Multiple Myeloma, AZD0120, Cell Therapy, CAR-T, DURGA-5, BCMA, CD19, ASCT ineligible, Transplant ineligible
Medical subject headings: Multiple Myeloma

What participants receive

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

AZD0120Biological
AZD0120, is a BCMA/CD19 dual CAR T-cell product, which is administered intravenously.
DaratumumabBiological
Induction, optional bridging and continuous therapy.
DexamethasoneDrug
Induction, optional bridging and continuous therapy.
IsatuximabBiological
Induction, optional bridging and continuous therapy.
LenalidomideDrug
Induction, optional bridging and continuous therapy.
BortezomibDrug
Induction therapy.
CyclophosphamideDrug
Lymphodepletion
FludarabineDrug
Lymphodepletion

Study groups in NCT07764978
Study group	Role	What they receive
Arm A: Investigational Arm	Experimental	Arm A is the sequence of induction with IsaVRd or DRd, apheresis, optional bridging therapy, lymphodepletion (cyclophosphamide and fludarabine), and AZD0120. Receives: Biological: AZD0120; Biological: Daratumumab; Drug: Dexamethasone; Biological: Isatuximab; Drug: Lenalidomide; Drug: Bortezomib; Drug: Cyclophosphamide; Drug: Fludarabine
Arm B: Control Arm	Active comparator	Arm B is the standard therapy induction with IsaVRd or DRd, followed by continuous IsaRd or DRd until disease progression or intolerable toxicity. Receives: Biological: Daratumumab; Drug: Dexamethasone; Biological: Isatuximab; Drug: Lenalidomide; Drug: Bortezomib

What is being measured

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

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.
Measured: 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
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.
Measured: Up to 9 years.

Secondary outcomes (13)

Complete Response Rate
The proportion of participants who achieved CR or better according to IMWG 2016 criteria, as assessed by BICR
Measured: Up to 9 years.
Overall Survival
Time from randomisation until date of death due to any cause
Measured: Up to 9 years.
Number and percentage of participants with adverse events as graded by CTCAE v6 and ASTCT Consensus Grading criteria
Adverse Event Incidence
Measured: Up to 9 years.
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.
Measured: Up to 9 years.
Number and percentage of participants with incidence of ADAs against AZD0120
Assessment humoral immunogenicity of AZ0120 based on incidence of ADAs.
Measured: Up to 9 years.
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.
Measured: Up to 9 years.
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.
Measured: Up to 9 years.
Overall Response Rate
Proportion of participants who achieved PR or better according to IMWG 2016 criteria
Measured: Up to 9 years
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.
Measured: Up to 9 years
Time to Response
Time from randomisation until the date of first documented objective response (PR or better), as assessed per IMWG 2016 criteria.
Measured: Up to 9 years
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.
Measured: Up to 9 years
Rate of sustained MRD negative CR
Proportion of participants who have achieved MRD negative status and have a response of CR or sCR
Measured: Up to 9 years
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
Measured: Up to 9 years

Timeline

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

26 Jun 202612 May 2034

First posted14 Aug 2026
Study start26 Jun 2026
Primary completion11 Jan 2029 (estimated)
Study completion12 May 2034 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Newly Diagnosed Multiple MyelomaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard regimens (IsaVRd and DRd) in participants with NDMM who are ineligible to receive ASCT as initial therapy.
Masking: None (open label)
Enrolment: 750 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07764978
Sponsor's protocol ID: D8312C00002
Acronym: DURGA-5
Status last verified: Aug 2026
First submitted: 1 Jul 2026
Last updated: 14 Aug 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.

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT07764978
Acronym / sponsor ID: DURGA-5 / D8312C00002
Conditions: Newly Diagnosed Multiple Myeloma
Keywords: Newly Diagnosed Multiple Myeloma (NDMM), Multiple Myeloma, AZD0120, Cell Therapy, CAR-T, DURGA-5, BCMA, CD19
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 750 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 26 Jun 2026 (actual)
Primary completion: 11 Jan 2029 (estimated)
Study completion: 12 May 2034 (estimated)
First posted: 14 Aug 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard regimens (IsaVRd and DRd) in participants with NDMM who are ineligible to receive ASCT as initial therapy.

Arm	Type	Receives
Arm A: Investigational Arm	Experimental	Biological: AZD0120, Biological: Daratumumab, Drug: Dexamethasone, Biological: Isatuximab, Drug: Lenalidomide, Drug: Bortezomib, Drug: Cyclophosphamide, Drug: FludarabineArm A is the sequence of induction with IsaVRd or DRd, apheresis, optional bridging therapy, lymphodepletion (cyclophosphamide and fludarabine), and AZD0120.
Arm B: Control Arm	Active comparator	Biological: Daratumumab, Drug: Dexamethasone, Biological: Isatuximab, Drug: Lenalidomide, Drug: BortezomibArm B is the standard therapy induction with IsaVRd or DRd, followed by continuous IsaRd or DRd until disease progression or intolerable toxicity.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Participants must be 18 years or older, at the time of signing the ICF.
Participant must have documented diagnosis of MM according to the IMWG diagnostic criteria.
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.
Participant must be deemed ineligible for ASCT while also having adequate organ function for CAR-T cell treatment.
Participant is a candidate to receive at least one of the regimens (IsaVRd or DRd) as determined by the Investigator.

Key exclusion criteria (14 listed)

Participant has active or prior CNS or meningeal involvement of MM.
Participant has primary amyloidosis, active plasma cell leukemia (≥5% circulating plasma cells), Waldenström macroglobulinemia, or POEMS syndrome.
Participant has significant neurological or psychiatric condition posing risk or impairing evaluation.
Participant has any other significant medical condition that increases unacceptable risk, interferes with therapy delivery, or confounds evaluation.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD0120AZD0120, is a BCMA/CD19 dual CAR T-cell product, which is administered intravenously.	Biological	Arm A: Investigational Arm
DaratumumabInduction, optional bridging and continuous therapy.	Biological	Arm A: Investigational Arm, Arm B: Control Arm
DexamethasoneInduction, optional bridging and continuous therapy.	Drug	Arm A: Investigational Arm, Arm B: Control Arm
IsatuximabInduction, optional bridging and continuous therapy.	Biological	Arm A: Investigational Arm, Arm B: Control Arm
LenalidomideInduction, optional bridging and continuous therapy.	Drug	Arm A: Investigational Arm, Arm B: Control Arm
BortezomibInduction therapy.	Drug	Arm A: Investigational Arm, Arm B: Control Arm
CyclophosphamideLymphodepletion	Drug	Arm A: Investigational Arm
FludarabineLymphodepletion	Drug	Arm A: Investigational Arm

Primary outcome

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.
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.

13 secondary outcomes

Complete Response Rate
Time frame: Up to 9 years.
Overall Survival
Time frame: 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.
Concentration of Circulating CAR-T+ Cells in Peripheral Blood
Time frame: Up to 9 years.
Number and percentage of participants with incidence of ADAs against AZD0120
Time frame: Up to 9 years.
Patient Reported Outcomes
Time frame: Up to 9 years.
Patient Reported Outcomes
Time frame: Up to 9 years.
Overall Response Rate
Time frame: Up to 9 years
Duration of Response
Time frame: Up to 9 years
Time to Response
Time frame: Up to 9 years
MRD negative CR rate
Time frame: Up to 9 years
Rate of sustained MRD negative CR
Time frame: Up to 9 years
Progression Free Survival 2 (PFS2)
Time frame: Up to 9 years

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Jen Brudno, MD study director

AstraZeneca

124 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AZD0120, Daratumumab and Dexamethasone in people with Newly Diagnosed Multiple Myeloma, run by AstraZeneca at 124 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 7 inclusion and 14 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 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 124 sites in United States, Germany, Australia, Japan, 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?

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.). 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?

On the ClinicalTrials.gov record for NCT07764978.

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 14 Aug 2026.