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NCT07735637RecruitingPhase 3

A Phase III, Multicentre Study to Evaluate Consolidation Treatment With AZD0120 Compared With ASCT, in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible (DURGA-6).

A Phase III, Open-label, Multicentre, Randomised Study Comparing Consolidation Treatment With AZD0120, an Autologous Dual Targeting Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, Versus Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible (TE NDMM) (DURGA-6)

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

The purpose of this study is to measure the efficacy of AZD0120 compared with ASCT in terms of progression-free survival (PFS) according to the International Myeloma Working Group (IMWG) criteria 2016, and MRD negative complete response (CR) rate at 9 months as assessed by Blinded Independent Central Review (BICR), in participants with TE NDMM. Study details include: * The study duration is estimated to be up to 13 years from the date the first participant is randomised. * For participants in Arm A (AZD0120), the total duration of participant follow-up will be 15 years (including a Long Term Follow-up study) after the last participant has received the AZD0120 infusion. * The treatment duration will be:- Arm A (AZD0120): lymphodepletion over 3 days, a single-day infusion of AZD0120, followed by a maximum of 2 years lenalidomide monotherapy maintenance treatment. * Arm B (ASCT): conditioning therapy over 24 to 48 hours, ASCT, followed by a maximum of 2 years lenalidomide monotherapy maintenance treatment. Disclosure Statement: This is an open-label, randomised study with 2 treatment arms.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
750 (estimated)
First submitted
22 Jul 2026
Start date
24 Sept 2026
Primary completion date
2 Nov 2028
Lead sponsor
AstraZeneca
NCT number
NCT07735637

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 750
  • From 24 Sept 2026 to the primary completion date, 2 Nov 2028
  • 97 sites in 18 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.
  • Participants who required the introduction of an additional agent therapy due to inadequate response.
  • Prior T-cell engager therapy directed at any target.
  • Prior CAR-T and/or CAR-NK cell therapy directed at any target for any indications
  • Prior any therapy that is targeted to BCMA and CD19.

Other illness

  • Primary amyloidosis, active plasma cell leukaemia (at diagnosis and/or at time of screening), Waldenstrom macroglobulinemia or POEMS syndrome.
  • Significant neurological or psychiatric condition
  • Significant medical condition that places the participant at an unacceptable risk for treatment-related complications

Who the study is looking for

  • ≥18 years of age.
  • Documented diagnosis of NDMM according to IMWG diagnostic criteria.
  • Documented measurable disease at diagnosis (serum M-protein ≥ 1.0 g/dL, urine M-protein 200 mg/24 hour, or serum Ig FLC 10 mg/dL (100 mg/L) and abnormal serum Ig kappa lambda FLC ratio)
  • Must have completed 4 to 6 cycles of induction therapy with any of the following approved regimens: anti-CD38+VRd, DVTd, DRd or VRd
  • Participant must have at least SD or better per IMWG response criteria (2016) after completion of induction, and prior to randomisation.
  • ECOG performance status score of 0 or 1.
  • Eligible for treatment with high-dose melphalan (200 mg/m²) followed by ASCT.
  • Adequate organ and bone marrow function.

Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (97)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BrisbaneAustraliaNot yet recruiting
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CamperdownAustraliaNot yet recruiting
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DarlinghurstAustraliaNot yet recruiting
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East MelbourneAustraliaNot yet recruiting
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FitzroyAustraliaRecruiting
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MelbourneAustraliaWithdrawn
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NedlandsAustraliaNot yet recruiting
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WestmeadAustraliaNot yet recruiting
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SalvadorBrazilNot yet recruiting
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São PauloBrazilNot yet recruiting
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CalgaryCanadaNot yet recruiting
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HalifaxCanadaNot yet recruiting
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MontrealCanadaNot yet recruiting
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SherbrookeCanadaNot yet recruiting
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BeijingChinaNot yet recruiting
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ShanghaiChinaNot yet recruiting
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BerlinGermanyNot yet recruiting
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DresdenGermanyNot yet recruiting
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EssenGermanyNot yet recruiting
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Freiburg im BreisgauGermanyNot yet recruiting
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HamburgGermanyNot yet recruiting
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LeipzigGermanyNot yet recruiting
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MünchenGermanyNot yet recruiting
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OldenburgGermanyNot yet recruiting
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AarhusDenmarkNot yet recruiting
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København ØDenmarkNot yet recruiting
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OdenseDenmarkNot yet recruiting
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BadalonaSpainNot yet recruiting
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BarcelonaSpainNot yet recruiting
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El PalmarSpainNot yet recruiting
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MadridSpainNot yet recruiting
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SalamancaSpainNot yet recruiting
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SantanderSpainNot yet recruiting
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SevilleSpainNot yet recruiting
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LilleFranceNot yet recruiting
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NantesFranceNot yet recruiting
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ParisFranceNot yet recruiting
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ToulouseFranceNot yet recruiting
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CambridgeUnited KingdomNot yet recruiting
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LondonUnited KingdomRecruiting
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BolognaItalyNot yet recruiting
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MilanItalyNot yet recruiting
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RomeItalyNot yet recruiting
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RozzanoItalyNot yet recruiting
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TorinoItalyNot yet recruiting
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NagoyaJapanNot yet recruiting
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SeoulSouth KoreaNot yet recruiting
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OsloNorwayNot yet recruiting
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GdanskPolandNot yet recruiting
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GliwicePolandNot yet recruiting
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KielcePolandNot yet recruiting
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KrakowPolandNot yet recruiting
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LublinPolandNot yet recruiting
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WroclawPolandNot yet recruiting
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RiyadhSaudi ArabiaNot yet recruiting
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SingaporeSingaporeNot yet recruiting
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TaipeiTaiwanNot yet recruiting
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TaoyuanTaiwanNot yet recruiting
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AtlantaUnited StatesNot yet recruiting
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AustinUnited StatesNot yet recruiting
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BostonUnited StatesNot yet recruiting
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Chapel HillUnited StatesNot yet recruiting
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CharlotteUnited StatesNot yet recruiting
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CharlottesvilleUnited StatesNot yet recruiting
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ChicagoUnited StatesNot yet recruiting
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ClevelandUnited StatesNot yet recruiting
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ColumbusUnited StatesNot yet recruiting
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DallasUnited StatesNot yet recruiting
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DenverUnited StatesNot yet recruiting
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DetroitUnited StatesNot yet recruiting
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DurhamUnited StatesNot yet recruiting
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GilbertUnited StatesNot yet recruiting
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GoodyearUnited StatesNot yet recruiting
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Great NeckUnited StatesNot yet recruiting
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HoustonUnited StatesNot yet recruiting
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JacksonvilleUnited StatesNot yet recruiting
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LexingtonUnited StatesNot yet recruiting
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Los AngelesUnited StatesWithdrawn
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MadisonUnited StatesNot yet recruiting
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MilwaukeeUnited StatesNot yet recruiting
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NewnanUnited StatesNot yet recruiting
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New YorkUnited StatesNot yet recruiting
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OrangeUnited StatesNot yet recruiting
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PhiladelphiaUnited StatesNot yet recruiting
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PhoenixUnited StatesNot yet recruiting
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PortlandUnited StatesNot yet recruiting
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RochesterUnited StatesNot yet recruiting
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San AntonioUnited StatesNot yet recruiting
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San FranciscoUnited StatesNot yet recruiting
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SeattleUnited StatesWithdrawn
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StanfordUnited StatesNot yet recruiting
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St LouisUnited StatesNot yet recruiting
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Stony BrookUnited StatesNot yet recruiting
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TampaUnited StatesNot yet recruiting
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The BronxUnited StatesNot yet recruiting
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Winston-SalemUnited StatesNot yet recruiting
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ZionUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.