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AZD0120 CAR-T therapy compared with stem cell transplant in newly diagnosed multiple myeloma

Compares AZD0120 with stem cell transplant in adults newly diagnosed with multiple myeloma.

Key facts

Who runs it
AstraZeneca AB
Where
Bologna, Milan, Rome, Rozzano, and Turin, ItalySee the 6 sitesAlso in 6 other countries, 29 sites
Registry title
A trial to learn how well AZD0120 works and about its safety in adults with transplant eligible newly diagnosed multiple myeloma.
Status
Not yet recruiting
Phase
Phase 3
People taking part
249 people, planned
Started
31 Oct 2026
Expected to end
9 Nov 2039
Type of study
Interventional
Record updated
12 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with newly diagnosed multiple myeloma who can have a stem cell transplant and have finished 4 to 6 cycles of first treatment.

Age
At least 18 years old.
Sex
All sexes can join.
Disease stage
Newly diagnosed multiple myeloma with measurable disease at diagnosis. The disease must be at least stable after first treatment. ECOG performance status score of 0 or 1.
Earlier treatment
Must have finished 4 to 6 cycles of approved first treatment (anti-CD38+VRd, DVTd, DRd or VRd) before joining. Must be able to have high-dose melphalan (200 mg/m²) followed by ASCT. Cannot have had earlier CAR-T, CAR-natural killer cell, BCMA- or CD19-targeted, or T-cell engager therapy.
Biomarker or test result
Measurable disease at diagnosis: serum M-protein of at least 1.0 g/dL, or urine M-protein of at least 200 mg/24 hour, or serum Ig FLC of at least 10 mg/dL (100 mg/L) with an abnormal serum Ig kappa lambda FLC ratio.

Main reasons for not taking part

  • Past or current myeloma in the brain or spinal fluid area (central nervous system or meninges)
  • Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia or POEMS syndrome
  • Significant neurological or psychiatric condition within 6 months before signing consent
  • Needed an extra drug because the first treatment did not work well enough
  • Any other serious medical condition that the investigator thinks makes treatment unsafe

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in Italy

Also in 6 other countries, 29 sites

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyNot yet recruiting
  • Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyNot yet recruiting
  • Istituto Europeo di Oncologia s.r.lMilan, ItalyNot yet recruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNot yet recruiting
  • Humanitas Mirasole S.p.A.Rozzano, ItalyNot yet recruiting
  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
AZD0120 CAR-T therapy compared with stem cell transplant in newly diagnosed multiple myelomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
12 October 2026