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
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:
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Conditions:
Amyloidosis
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Age: Between 18 Years - 100 Years
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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: