A Phase 3 Randomized Controlled Open-label Multicenter Safety and Efficacy Study of Dexamethasone Plus IXAZOMIB (MLN9708) or Physicians Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis
The purpose of this study is to determine whether dexamethasone plus IXAZOMIB improves hematologic response, 2-year vital organ (that is, heart or kidney) deterioration and mortality rate versus a physician's choice of a chemotherapy regimen in participants diagnosed with relapsed or refractory systemic light chain (AL) amyloidosis.
This is a phase 3, randomized, controlled, open-label, multicenter study of the oral formulation of dexamethasone plus IXAZOMIB compared with treatment chosen by the investigator from a prespecified list of regimens available in clinical practice.
- IRB Number: 1208009429 (C16011)
- Research Study Identifier: TX2881
- Principal Investigator: Rafat Abonour, MD