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

R
Rafat Abonour, MD

Primary Investigator

Overview

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.

Description

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.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Amyloidosis
  • Age: Between 18 Years - 100 Years
  • Gender: All

Inclusion Criteria
In 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.


Additional Information:
Participants will be compensated for their participation.

Updated on 20 Nov 2022. Study ID: 1208009429 (C16011)

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