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
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
- Diseases
- Multiple myeloma
- 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
Sites (35)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charite Universitaetsmedizin Berlin KöR | Berlin | Germany | Not yet recruiting |
| Technische Universitaet Dresden | Dresden | Germany | Not yet recruiting |
| Universitaetsklinikum Essen (AoR) | Essen | Germany | Not yet recruiting |
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany | Not yet recruiting |
| Universitaet Leipzig | Leipzig | Germany | Not yet recruiting |
| Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) | Munich | Germany | Not yet recruiting |
| Klinikum Oldenburg Aor | Oldenburg | Germany | Not yet recruiting |
| Region Midtjylland | Aarhus N | Denmark | Not yet recruiting |
| Region Hovedstaden | Copenhagen Oe | Denmark | Not yet recruiting |
| Region Syddanmark | Odense C | Denmark | Not yet recruiting |
| Institut Catala d'Oncologia | Badalona | Spain | Not yet recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario Ramón y Cajal | Madrid | Spain | Not yet recruiting |
| University Clinical Hospital Virgen De La Arrixaca | Murcia | Spain | Not yet recruiting |
| Complejo Asistencial Universitario de Salamanca | Salamanca | Spain | Not yet recruiting |
| Hospital Universitario Marqués de Valdecilla | Santander | Spain | Not yet recruiting |
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Not yet recruiting |
| Centre Hospitalier Universitaire de Lille | Lille | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Nantes | Nantes | France | Not yet recruiting |
| Hopital Saint Louis | Paris | France | Not yet recruiting |
| Hopital Saint Antoine | Paris Cedex 12 | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Toulouse | Toulouse Cedex 9 | France | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico | Bologna | Italy | Not yet recruiting |
| Istituto Europeo di Oncologia s.r.l | Milan | Italy | Not yet recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori | Milan | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Not yet recruiting |
| Humanitas Mirasole S.p.A. | Rozzano | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino | Turin | Italy | Not yet recruiting |
| Oslo Universitetssykehus HF | Oslo | Norway | Not yet recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie | Cracow | Poland | Not yet recruiting |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | Not yet recruiting |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy | Gliwice | Poland | Not yet recruiting |
| Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach | Kielce | Poland | Not yet recruiting |
| Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli | Lublin | Poland | Not yet recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu | Wroclaw | Poland | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.