ClinicaliQ Trial Snapshot
- 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). — Recruiting • Phase III • Cardiology / Cardiovascular • NCT07735637.
- Treatment Being Tested: AZD0120 (a novel consolidation therapy) is being compared against autologous stem cell transplantation (ASCT) as consolidation treatment in newly diagnosed multiple myeloma, with primary endpoints of progression-free survival and MRD-negative complete response rates.
- Patient Eligibility: The trial includes transplant-eligible patients with newly diagnosed multiple myeloma who have undergone induction therapy and are suitable for consolidation treatment according to standard clinical criteria.
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- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
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What This Trial Is Studying
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…
Eligibility Snapshot
- : * ≥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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.