Clinical Trials

Find a Trial

Trial Summary

Protocol No.C16011
StatusOPEN TO ACCRUAL
Principal InvestigatorAbonour, Rafat
ScopeNational
PhasePhase III
Age GroupAdult
TitleA Phase 3, Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physician's Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis
DescriptionThis is a phase 3, randomized, controlled, open-label, multicenter study of the oral formulation of dexamethasone plus MLN9708 compared with treatment chosen by the investigator from a prespecified list of regimens available in clinical practice. Treatment options will include: dexamethasone alone, dexamethasone plus an alkylating agent (melphalan or cyclophosphamide), or dexamethasone plus an immunomodulatory drug (IMiD, thalidomide or lenalidomide) in patients with relapsed or refractory AL amyloidosis. Crossover to the investigational treatment arm is not permitted during participation in this study.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Male or female patients 18 years or older
  • Biopsy-proven AL amyloidosis with relapsed or refractory disease despite 1 or 2 prior therapies. Patients may be proteasome inhibitor-exposed or naive, but cannot be refractory to proteasome inhibitor therapy
For a full list of participation criteria, please visit ClinicalTrials.gov.
Applicable Disease SitesMyeloproliferative Disorders
Participating InstitutionsIndiana University (IU)
  • Indiana University Hospital / IU Simon Cancer Center
  • Spring Mill Medical Center
Treatment TypeTreatment
ContactPhone: (317) 278-5632
Email: iutrials@iu.edu