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).

Part of paid clinical trials in Tampa, Florida.

Sponsor
AstraZeneca
Study ID
NCT07735637
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Newly Diagnosed Multiple Myeloma (NDMM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD0120 — BIOLOGICAL
    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.
  • Cyclophosphamide — DRUG
    Arm A: Cyclophosphamide will be given intravenously as lymphodepletion conditioning.
  • Fludarabine — DRUG
    Arm A: Fludarabine will be given intravenously as lymphodepletion conditioning.
  • Melphalan (part of ASCT) — DRUG
    Arm B - Autologous stem cell transplant: High-dose melphalan will be given over 1-2 days, followed by autologous stem cell rescue.
  • Lenalidomide — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jul 30, 2026
Start date
Aug 25, 2026
Status verified
May 2026
Primary completion
Oct 11, 2028
Completion
Nov 9, 2039

Study Design

Enrollment
750 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: AZD0120
    AZD0120 is an autologous chimeric antigen receptor T-cell (CAR-T) therapy.
  • Active Comparator: Arm B: Autologous Stem Cell Transplant (ASCT)
    ASCT: High-dose melphalan followed by autologous stem cell rescue

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to approximately 13 years. ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Research SiteTampaFlorida33612-
Research SiteAtlantaGeorgia30322-
Research SiteAtlantaGeorgia30342-
Research SiteChicagoIllinois60637-
Research SiteDetroitMichigan48201-
Research SiteRochesterMinnesota55905-
Research SiteClevelandOhio44195-
Research SiteSan AntonioTexas78229-
Research SiteSeattleWashington98104-
Research SiteMilwaukeeWisconsin53226-

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