Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
AstraZeneca
Study ID
NCT07764978
Phase
PHASE3
Status
Recruiting
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Conditions

  • Newly Diagnosed Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD0120 — BIOLOGICAL
    AZD0120, is a BCMA/CD19 dual CAR T-cell product, which is administered intravenously.
  • Daratumumab — BIOLOGICAL
    Induction, optional bridging and continuous therapy.
  • Dexamethasone — DRUG
    Induction, optional bridging and continuous therapy.
  • Isatuximab — BIOLOGICAL
    Induction, optional bridging and continuous therapy.
  • Lenalidomide — DRUG
    Induction, optional bridging and continuous therapy.
  • Bortezomib — DRUG
    Induction therapy.
  • Cyclophosphamide — DRUG
    Lymphodepletion
  • Fludarabine — DRUG
    Lymphodepletion

Study Details

This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of standard induction regimens (IsaVRd and DRd) followed by AZD0120 versus standard induction regimens followed by continuous therapy (IsaRd and DRd) in participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT) as initial therapy.

Key Dates

First listed
Aug 14, 2026
Start date
Jun 26, 2026
Status verified
Aug 2026
Primary completion
Jan 11, 2029
Completion
May 12, 2034

Study Design

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

Arms

  • Experimental: Arm A: Investigational Arm
    Arm A is the sequence of induction with IsaVRd or DRd, apheresis, optional bridging therapy, lymphodepletion (cyclophosphamide and fludarabine), and AZD0120.
  • Active Comparator: Arm B: Control Arm
    Arm B is the standard therapy induction with IsaVRd or DRd, followed by continuous IsaRd or DRd until disease progression or intolerable toxicity.

Primary Outcome Measure

PFS in NDMM who are ineligible to receive ASCT is measured to demonstrate the superiority of IsaVRd or DRd induction followed by AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd. [ Time Frame: Up to 9 years. ]

Central Contacts

Locations (45)

FacilityCityStateZIPSite coordinators
Research SiteGilbertArizona85234-
Research SitePhoenixArizona85054-
Research SiteTucsonArizona85719-
Research SiteOrangeCalifornia92868-
Research SiteSanta MonicaCalifornia90404-
Research SiteAuroraColorado80045-
Research SiteDenverColorado80218-
Research SiteNew HavenConnecticut06510-
Research SiteCoral GablesFlorida33156-
Research SiteTampaFlorida33606-
Research SiteAtlantaGeorgia30322-
Research SiteChicagoIllinois60607-
Research SiteIowa CityIowa52242-
Research SiteWichitaKansas67214-
Research SiteLouisvilleKentucky40207-
Research SiteBaton RougeLouisiana70809-
Research SiteBaltimoreMaryland21201-
Research SiteDetroitMichigan48201-
Research SiteSt LouisMissouri63110-
Research SiteEast BrunswickNew Jersey08816-
Research SiteAlbanyNew York12208-
Research SiteNew Hyde ParkNew York11042-
Research SiteNew YorkNew York10016-
Research SiteNew YorkNew York10029-
Research SiteNew YorkNew York10032-
Research SiteThe BronxNew York10467-
Research SiteChapel HillNorth Carolina27599-
Research SiteCharlotteNorth Carolina28203-
Research SiteDurhamNorth Carolina27705-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteWinston-SalemNorth Carolina27157-
Research SiteCincinnatiOhio45236-
Research SiteClevelandOhio44195-
Research SiteColumbusOhio43210-
Research SiteMontgomeryOhio45242-
Research SitePortlandOregon97239-
Research SiteNashvilleTennessee37203-
Research SiteNashvilleTennessee37219-
Research SiteDallasTexas75235-
Research SiteHoustonTexas77030-
Research SiteFairfaxVirginia22031-
Research SitePuyallupWashington98373-
Research SiteSeattleWashington98101-
Research SiteSeattleWashington98104-
Research SiteMilwaukeeWisconsin53226-

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