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2026-525367-40-00Not yet recruitingPhase 3

A trial to learn how well AZD0120 works and about its safety in adults with transplant eligible newly diagnosed multiple myeloma.

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: EU CTIS (euclinicaltrials.eu) · Last updated 12 Oct 2026

Next steps

Brief summary (registry, in English)

Primary Objective 1: To demonstrate the superiority of single administration of AZD0120 compared with ASCT as consolidation followed by lenalidomide maintenance by assessment of PFS in participants with TE NDMM. Primary Objective 2: To demonstrate the superiority of single administration of AZD0120 compared with ASCT as consolidation followed by lenalidomide maintenance by assessment of MRD negative CR rate at 9 months in participants with TE NDMM.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
249 (estimated)
First submitted
17 Jun 2026
Start date
31 Oct 2026
Lead sponsor
AstraZeneca AB
EU CT number
2026-525367-40-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 249
  • 35 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participant has a known active, or prior history of central nervous system involvement or exhibits clinical signs of meningeal involvement of MM.
  • Participant has significant neurological or psychiatriccondition within 6 months before signing ICF.
  • Prior treatment with CAR-T and/or CAR-natural killer cell therapies directed at any target for any indications and any therapy that is targeted to BCMA and CD19.
  • Participant received any prior T-cell engager therapy directed at any target.

Other illness

  • Participant has primary amyloidosis, active plasma cell leukaemia at time of screening, Waldenstrom macroglobulinemia or POEMS syndrome.
  • Participant has any other significant medical condition which, in the opinion of the investigator, places the participant at an unacceptable risk for treatment-related complications, could interfere with the successful or safe delivery of therapy, or could interfere with evaluation of study intervention or interpretation of participant safety or study results.

Other

  • Participants who required the introduction of an additional agent due to inadequate response.

Who the study is looking for

  • Participant must be at least 18 years, at the time of signing the ICF.
  • ECOG performance status score of 0 or 1.
  • Participant must be eligible for treatment with high-dose melphalan (200 mg/m²) followed by ASCT.
  • Participant must have adequate organ and bone marrow function (as detailed in CSP Table 9).
  • Participant must have documented measurable disease at diagnosis, as defined by any of the following: (a) Serum M-protein level ≥ 1.0 g/dL (b) Urine M-protein level ≥ 200 mg/24 hour (c) Serum Ig FLC ≥ 10 mg/dL (100 mg/L) and abnormal serum Ig kappa lambda FLC ratio.
  • Participant must have documented diagnosis of NDMM, per IMWG diagnostic criteria, and must have completed 4 to 6 cycles of approved induction therapy (anti-CD38+VRd, DVTd, DRd or VRd) prior to randomisation.
  • Participant must have at least SD or better per IMWG 2016 after completion of induction, and prior to randomisation.

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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (35)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Charite Universitaetsmedizin Berlin KöRBerlinGermanyNot yet recruiting
Technische Universitaet DresdenDresdenGermanyNot yet recruiting
Universitaetsklinikum Essen (AoR)EssenGermanyNot yet recruiting
University Medical Center Hamburg-EppendorfHamburgGermanyNot yet recruiting
Universitaet LeipzigLeipzigGermanyNot yet recruiting
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)MunichGermanyNot yet recruiting
Klinikum Oldenburg AorOldenburgGermanyNot yet recruiting
Region MidtjyllandAarhus NDenmarkNot yet recruiting
Region HovedstadenCopenhagen OeDenmarkNot yet recruiting
Region SyddanmarkOdense CDenmarkNot yet recruiting
Institut Catala d'OncologiaBadalonaSpainNot yet recruiting
Hospital Universitari Vall d'HebronBarcelonaSpainNot yet recruiting
Hospital Universitario Ramón y CajalMadridSpainNot yet recruiting
University Clinical Hospital Virgen De La ArrixacaMurciaSpainNot yet recruiting
Complejo Asistencial Universitario de SalamancaSalamancaSpainNot yet recruiting
Hospital Universitario Marqués de ValdecillaSantanderSpainNot yet recruiting
University Hospital Virgen Del Rocio S.L.SevillaSpainNot yet recruiting
Centre Hospitalier Universitaire de LilleLilleFranceNot yet recruiting
Centre Hospitalier Universitaire de NantesNantesFranceNot yet recruiting
Hopital Saint LouisParisFranceNot yet recruiting
Hopital Saint AntoineParis Cedex 12FranceNot yet recruiting
Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9FranceNot yet recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBolognaItalyNot yet recruiting
Istituto Europeo di Oncologia s.r.lMilanItalyNot yet recruiting
Fondazione IRCCS - Istituto Nazionale dei TumoriMilanItalyNot yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRomeItalyNot yet recruiting
Humanitas Mirasole S.p.A.RozzanoItalyNot yet recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurinItalyNot yet recruiting
Oslo Universitetssykehus HFOsloNorwayNot yet recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracowPolandNot yet recruiting
Uniwersyteckie Centrum KliniczneGdanskPolandNot yet recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut BadawczyGliwicePolandNot yet recruiting
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w KielcachKielcePolandNot yet recruiting
Centrum Onkologii Ziemi Lubelskiej im sw Jana z DukliLublinPolandNot yet recruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we WroclawiuWroclawPolandNot yet recruiting

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