The Role of Ixazomib in Autologous Stem Cell Transplant in Relapsed Myeloma - Myeloma XII (ACCoRd)

Study design: Randomised, controlled, multi-centre, open-label, phase III trial (with a single intervention registration phase). Primary Objectives The primary objectives of this study are to determine: * The impact on Depth of Response (DoR: less than VGPR versus VGPR or better) when salvage ASCT conditioning is augmented by the addition of a proteasome inhibitor * The influence of a consolidation and maintenance strategy on the Durability of Response (DuR:PFS) Secondary objectives The secondary objectives of this study are to determine: * Overall survival * Time to disease progression

Trial Details

NCT ID
NCT03562169
Phase
PHASE3
Sponsor
University of Leeds
Status
RECRUITING
Cancer Type
Multiple Myeloma
Interventions
  • Ixazomib, thalidomide, & dexamethasone (ITD) re-induction
  • Conventional autologous stem cell transplant (ASCT-con)
  • Augmented autologous stem cell transplant (ASCT-aug)
  • ITD consolidation and ixazomib maintenance vs. No further therapy
Locations (sample)
  • Aberdeen, United Kingdom|57.14369,-2.09814
  • Airdrie, United Kingdom|55.86602,-3.98025
  • Ayr, United Kingdom|55.46273,-4.63393
  • Barnsley, United Kingdom|53.55,-1.48333
  • Basingstoke, United Kingdom|51.26249,-1.08708

Key Eligibility Criteria

  • Diagnosed with relapsed MM (with measurable disease, according to IMWG criteria (Appendix 2)) previously treated with ASCT).
  • First Progressive Disease (PD) at least 12 months following first ASCT, requiring therapy.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (Appendix 3).
  • Aged at least 18 years.

For full eligibility, visit ClinicalTrials.gov.

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