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
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
Age: Between 18 - 100 Years
Gender: Male or Female
Biopsy-proven AL amyloidosis with relapsed or refractory disease despite 1 or 2 prior therapies.
Measurable disease as defined by serum differential free light chain concentration (dFLC)
Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
Amyloidosis due to mutations of the transthyretin gene or presence of other non-AL amyloidosis
Female patients who are lactating, breastfeeding or pregnant
Evidence of current uncontrolled cardiovascular conditions
Inability to swallow medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment
Ongoing or active infection, active hepatitis B virus infect, active hepatitis C infection, or known human immunodeficiency virus (HIV) positive
Known allergy to any of the study medications, their analogues or excipients
Systemic treatment with strong inhibitors of CYP1A2, strong inhibitors of CYP3A, or strong CYP3A inducers, or use of Ginkgo biloba or St. John's wort within 14 days before the first dose of study treatment
Diagnosed or treated for another malignancy within 5 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection