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's the purpose of this trial?

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. 

This is an upcoming trial that has not yet started accepting patients.

What will happen during the trial?

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.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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.

Additional Trial Information

Phase 3

Enrollment: 750 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Florida

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Not Yet Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Not Yet Accepting

Illinois

University of Chicago Medicine Comprehensive Cancer Center

Chicago, IL

Not Yet Accepting

Michigan

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Not Yet Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Not Yet Accepting

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Not Yet Accepting

Ohio

Cleveland Clinic - Taussig Cancer Center Taussig Cancer Institute

Cleveland, OH

Not Yet Accepting
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