NCT07735637 · AstraZeneca
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).
(DURGA-6)
What this study is about
The purpose of this study is to measure the effectiveness of AZD0120 compared with ASCT in terms of time without the disease getting worse (PFS) according to the International Myeloma Working Group (IMWG) criteria 2016, and MRD negative full disappearance of disease signs (CR) rate at 9 months as assessed by Blinded Independent Central Review (BICR), in participants with TE NDMM.
View original scientific description
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.
Interventions
BIOLOGICAL
AZD0120
Arm A: AZD0120 - autologous BCMA/CD19 dual-targeting CAR-T cells. Participants will receive lymphodepletion conditioning (cyclophosphamide and fludarabine) followed by AZD0120 CAR-T cell infusion.
DRUG
Cyclophosphamide
Arm A: Cyclophosphamide will be given intravenously as lymphodepletion conditioning.
DRUG
Fludarabine
Arm A: Fludarabine will be given intravenously as lymphodepletion conditioning.
DRUG
Melphalan (part of ASCT)
Arm B - Autologous stem cell transplant: High-dose melphalan will be given over 1-2 days, followed by autologous stem cell rescue.
DRUG
Lenalidomide
Arm A and Arm B: Lenalidomide maintenance treatment will be started in both Arm A and Arm B after AZD0120 therapy or ASCT, respectively. Lenalidomide maintenance on study will be continued up to 2 years.
Primary outcome measures
Progression-Free Survival (PFS)
Time frame: Up to approximately 13 years.
PFS is defined as time from randomisation until progression as assessed by Blinded Independent Central Review, or death due to any cause, whichever occurs first.
Minimal Residual Disease (MRD) negative Complete Response Rate (CRR)
Time frame: Up to approximately 13 years.
MRD negative CRR is defined as the proportion of participants with a MRD negative status and who have a response of CR or a stringent CR.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ≥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.
Exclusion criteria
- Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.
- 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
- 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.
Where
- Gilbert, Arizona
- Goodyear, Arizona
- Phoenix, Arizona
- Los Angeles, California
- Orange, California
- San Francisco, California
- Stanford, California
- Denver, Colorado
- Jacksonville, Florida
- Tampa, Florida
- Atlanta, Georgia
- Newnan, Georgia
And 28 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 21, 2026 · Source of record for eligibility and locations