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2025-524014-29-00Not yet recruitingPhase 3

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

A Phase III Open-Label, Randomised, Multicentre Study of Consolidation with a Single Administration of AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against BCMA and CD19, Compared with Continuous Standard Therapy in Participants with NDMM Who Are Ineligible to Receive ASCT as Initial Therapy (DURGA-5).

Source: EU CTIS (euclinicaltrials.eu) · Last updated 8 Sept 2026

Next steps

Brief summary (registry, in English)

Primary Objective 1: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 DRd or IsaRd by assessment of PFS in participants with NDMM who ineligible to receive ASCT as initial therapy. Primary Objective 2: 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 DRd or IsaRd by assessment of MRD negative CR rate at 9 months in participants with NDMM who are ineligible to receive ASCT as initial therapy."

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
234 (estimated)
First submitted
5 May 2026
Start date
27 May 2026
Lead sponsor
AstraZeneca AB
EU CT number
2025-524014-29-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 234
  • 42 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 active or prior CNS or meningealinvolvement of MM.
  • 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.

Other illness

  • Participant has primary amyloidosis, active plasma cellleukemia (≥5% circulating plasma cells), Waldenströmmacroglobulinemia, or POEMS syndrome.
  • Participant has a history of haematologic malignancies, other than MM, regardless of remission status.
  • Participant is positive for any of the following: a. HIV: Known to be seropositive for HIV (including any history of HIV). b. Chronic or active hepatitis B c. Active hepatitis C: Hepatitis C infection d. 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.

Other

  • 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
  • Participant has significant neurological or psychiatriccondition posing risk or impairing evaluation.
  • Participant has any other significant medical conditionthat increases unacceptable risk, interferes with therapydelivery, or confounds evaluation.
  • Participant has COPD with an FEV1 < 50% of predicted normal.

Who the study is looking for

  • Participants must be 18 years or older, at the time ofsigning the ICF.
  • Participant must have documented diagnosis of MMaccording 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) andabnormal 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.
  • 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.

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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (42)

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

SiteCityCountrySite status
Charite Universitaetsmedizin Berlin KöRBerlinGermanyNot yet recruiting
Universitaetsklinikum Koeln AöRCologneGermanyNot yet recruiting
Technische Universitaet DresdenDresdenGermanyNot yet recruiting
Universitaetsklinikum Essen (AoR)EssenGermanyNot yet recruiting
Medical Center- University of FreiburgFreiburg im BreisgauGermanyNot yet recruiting
University Medical Center Hamburg-EppendorfHamburgGermanyNot yet recruiting
Universitaet LeipzigLeipzigGermanyNot yet recruiting
Universitaetsklinikum Magdeburg AöRMagdeburgGermanyNot yet recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainzGermanyNot yet recruiting
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)MunichGermanyNot yet recruiting
Klinikum NuernbergNurembergGermanyNot yet recruiting
Universitaetsklinikum Wuerzburg AöRWuerzburgGermanyNot yet recruiting
Region MidtjyllandAarhus NDenmarkNot yet recruiting
Institut Catala d'OncologiaBadalonaSpainNot yet recruiting
Hospital Clinic de BarcelonaBarcelonaSpainNot yet recruiting
Hospital Universitario 12 de OctubreMadridSpainNot yet recruiting
Hospital General Universitario Gregorio MarañónMadridSpainNot yet recruiting
Clinica Universidad de NavarraMadridSpainNot yet recruiting
Clínica Universidad de navarraPamplonaSpainNot yet recruiting
Complejo Asistencial Universitario de SalamancaSalamancaSpainNot yet recruiting
University Hospital Virgen Del Rocio S.L.SevillaSpainNot yet recruiting
Hospital Universitario Y Politecnico La FeValenciaSpainNot yet recruiting
Centre Hospitalier Universitaire de LilleLilleFranceNot yet recruiting
Centre Hospitalier Universitaire de NantesNantesFranceNot yet recruiting
Hopital Saint LouisParisFranceNot yet recruiting
Centre Hospitalier Universitaire de PoitiersPoitiersFranceNot 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
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 w PoznaniuPoznanPolandNot yet recruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we WroclawiuWroclawPolandNot yet recruiting
Sahlgrenska University Hospital-Vaestra GoetalandsregionenGoteborgSwedenNot yet recruiting
Karolinska University HospitalHuddingeSwedenNot yet recruiting
Region Skane Skanes UniversitetssjukhusLundSwedenNot yet recruiting

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