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).

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

Trial Details

NCT ID
NCT07735637
Phase
PHASE3
Sponsor
AstraZeneca
Status
RECRUITING
Cancer Type
Multiple Myeloma
Interventions
  • AZD0120
  • Cyclophosphamide
  • Fludarabine
  • Melphalan (part of ASCT)
  • Lenalidomide
Locations (sample)
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Goodyear, Arizona, United States|33.43532,-112.35821
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orange, California, United States|33.78779,-117.85311

Key Eligibility 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 abn…
  • Must have completed 4 to 6 cycles of induction therapy with any of the following approved regimens: anti-CD38+VRd, DVTd, DRd or VRd

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Multiple Myeloma Trials on Trialify →