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
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
- Diseases
- Multiple myeloma
- 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
Sites (42)
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 |
| Universitaetsklinikum Koeln AöR | Cologne | Germany | Not yet recruiting |
| Technische Universitaet Dresden | Dresden | Germany | Not yet recruiting |
| Universitaetsklinikum Essen (AoR) | Essen | Germany | Not yet recruiting |
| Medical Center- University of Freiburg | Freiburg im Breisgau | Germany | Not yet recruiting |
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany | Not yet recruiting |
| Universitaet Leipzig | Leipzig | Germany | Not yet recruiting |
| Universitaetsklinikum Magdeburg AöR | Magdeburg | Germany | Not yet recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR | Mainz | Germany | Not yet recruiting |
| Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) | Munich | Germany | Not yet recruiting |
| Klinikum Nuernberg | Nuremberg | Germany | Not yet recruiting |
| Universitaetsklinikum Wuerzburg AöR | Wuerzburg | Germany | Not yet recruiting |
| Region Midtjylland | Aarhus N | Denmark | Not yet recruiting |
| Institut Catala d'Oncologia | Badalona | Spain | Not yet recruiting |
| Hospital Clinic de Barcelona | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Not yet recruiting |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Not yet recruiting |
| Clinica Universidad de Navarra | Madrid | Spain | Not yet recruiting |
| Clínica Universidad de navarra | Pamplona | Spain | Not yet recruiting |
| Complejo Asistencial Universitario de Salamanca | Salamanca | Spain | Not yet recruiting |
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Not yet recruiting |
| Hospital Universitario Y Politecnico La Fe | Valencia | 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 |
| Centre Hospitalier Universitaire de Poitiers | Poitiers | 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 |
| 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 w Poznaniu | Poznan | Poland | Not yet recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu | Wroclaw | Poland | Not yet recruiting |
| Sahlgrenska University Hospital-Vaestra Goetalandsregionen | Goteborg | Sweden | Not yet recruiting |
| Karolinska University Hospital | Huddinge | Sweden | Not yet recruiting |
| Region Skane Skanes Universitetssjukhus | Lund | Sweden | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.