NCT07735637RecruitingPhase 3
A Phase III, Multicentre Study to Evaluate Consolidation Treatment With AZD0120 Compared With ASCT, in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible (DURGA-6).
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: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to measure the efficacy of AZD0120 compared with ASCT in terms of progression-free survival (PFS) according to the International Myeloma Working Group (IMWG) criteria 2016, and MRD negative complete response (CR) rate at 9 months as assessed by Blinded Independent Central Review (BICR), in participants with TE NDMM. Study details include: * The study duration is estimated to be up to 13 years from the date the first participant is randomised. * For participants in Arm A (AZD0120), the total duration of participant follow-up will be 15 years (including a Long Term Follow-up study) after the last participant has received the AZD0120 infusion. * The treatment duration will be:- Arm A (AZD0120): lymphodepletion over 3 days, a single-day infusion of AZD0120, followed by a maximum of 2 years lenalidomide monotherapy maintenance treatment. * Arm B (ASCT): conditioning therapy over 24 to 48 hours, ASCT, followed by a maximum of 2 years lenalidomide monotherapy maintenance treatment. Disclosure Statement: This is an open-label, randomised study with 2 treatment arms.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 750 (estimated)
- First submitted
- 22 Jul 2026
- Start date
- 24 Sept 2026
- Primary completion date
- 2 Nov 2028
- Lead sponsor
- AstraZeneca
- Diseases
- Multiple myeloma
- NCT number
- NCT07735637
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 750
- From 24 Sept 2026 to the primary completion date, 2 Nov 2028
- 97 sites in 18 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.
- Participants who required the introduction of an additional agent therapy due to inadequate response.
- Prior T-cell engager therapy directed at any target.
- Prior CAR-T and/or CAR-NK cell therapy directed at any target for any indications
- Prior any therapy that is targeted to BCMA and CD19.
Other illness
- Primary amyloidosis, active plasma cell leukaemia (at diagnosis and/or at time of screening), Waldenstrom macroglobulinemia or POEMS syndrome.
- Significant neurological or psychiatric condition
- Significant medical condition that places the participant at an unacceptable risk for treatment-related complications
Who the study is looking for
- ≥18 years of age.
- Documented diagnosis of NDMM according to IMWG diagnostic criteria.
- Documented measurable disease at diagnosis (serum M-protein ≥ 1.0 g/dL, urine M-protein 200 mg/24 hour, or serum Ig FLC 10 mg/dL (100 mg/L) and abnormal serum Ig kappa lambda FLC ratio)
- Must have completed 4 to 6 cycles of induction therapy with any of the following approved regimens: anti-CD38+VRd, DVTd, DRd or VRd
- Participant must have at least SD or better per IMWG response criteria (2016) after completion of induction, and prior to randomisation.
- ECOG performance status score of 0 or 1.
- Eligible for treatment with high-dose melphalan (200 mg/m²) followed by ASCT.
- Adequate organ and bone marrow function.
Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers
Sites (97)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | Brisbane | Australia | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Camperdown | Australia | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Darlinghurst | Australia | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | East Melbourne | Australia | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Fitzroy | Australia | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Melbourne | Australia | Withdrawn |
| Research Site Coordinator of this site? Confirm its status | Nedlands | Australia | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Westmead | Australia | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Salvador | Brazil | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | São Paulo | Brazil | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Calgary | Canada | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Halifax | Canada | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Sherbrooke | Canada | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Dresden | Germany | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Essen | Germany | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Hamburg | Germany | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Leipzig | Germany | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | München | Germany | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Oldenburg | Germany | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Aarhus | Denmark | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | København Ø | Denmark | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Odense | Denmark | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Badalona | Spain | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | El Palmar | Spain | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Salamanca | Spain | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Santander | Spain | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Seville | Spain | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Lille | France | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Nantes | France | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Toulouse | France | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Bologna | Italy | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Rozzano | Italy | Not yet recruiting |
| Research site Coordinator of this site? Confirm its status | Torino | Italy | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Nagoya | Japan | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Oslo | Norway | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Gdansk | Poland | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Gliwice | Poland | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Kielce | Poland | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Krakow | Poland | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Lublin | Poland | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Wroclaw | Poland | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Singapore | Singapore | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Taipei | Taiwan | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Atlanta | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Austin | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Boston | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Chapel Hill | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Charlotte | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Charlottesville | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Chicago | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Cleveland | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Columbus | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Dallas | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Denver | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Detroit | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Durham | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Gilbert | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Goodyear | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Great Neck | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Houston | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Jacksonville | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Lexington | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Los Angeles | United States | Withdrawn |
| Research Site Coordinator of this site? Confirm its status | Madison | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Milwaukee | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Newnan | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Orange | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Philadelphia | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Phoenix | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Portland | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Rochester | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | San Antonio | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | San Francisco | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Seattle | United States | Withdrawn |
| Research Site Coordinator of this site? Confirm its status | Stanford | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | St Louis | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Stony Brook | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Tampa | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | The Bronx | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Winston-Salem | United States | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Zion | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.