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).

Study acronym: DURGA-6
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Notable Recruitment opened Show 5 more changesShow less
    • Trial sites expanded: 65 → 114 locations
    • Primary completion date: Oct 11, 2028 to Nov 2, 2028
    • Study completion date: Nov 9, 2039 to Nov 17, 2039
    • Start date changed from estimate of Aug 25, 2026 to Sep 24, 2026
    • Eligibility criteria expanded, about 16 words
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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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.
Trial Details
NCT Number NCT07735637
Lead Sponsor AstraZeneca
Conditions
(from sponsor)
Newly Diagnosed Multiple Myeloma (NDMM)
Related terms Multiple Myeloma
Enrollment 750 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov