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).

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07735637

This Phase III study evaluates AZD0120 versus ASCT in transplant-eligible NDMM patients. Participants must be ≥18, have measurable disease, and completed induction therapy. Arm A receives AZD0120 CAR-T cells post-lymphodepletion; Arm B undergoes ASCT with melphalan. Both arms receive up to 2 years of lenalidomide maintenance.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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.

Locations

FACILITYZIPCITYSTATE
Research Site85234GilbertArizona
Research Site85338GoodyearArizona
Research Site85028PhoenixArizona
Research Site90095Los AngelesCalifornia
Research Site92868OrangeCalifornia
Research Site94110San FranciscoCalifornia
Research Site94305-5824StanfordCalifornia
Research Site80218DenverColorado
Research Site32224JacksonvilleFlorida
Research Site33612TampaFlorida

Get This Program In Your Inbox

You can sign up and apply your patients for this program.