Full 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
Amyloidosis is a disorder in which abnormal proteins build up in tissues and organs. Clumps of the abnormal proteins are called amyloid deposits. Amyloidosis may be treated with chemotherapy, but the disease often returns.
The purpose of this study is to see if treatment with the drug ixazomib (MLN9708) is more effective than standard therapies in patients with systemic light chain amyloidosis that persists or has returned despite prior therapy. Patients will be randomly assigned to receive ixazomib or a standard oral therapy chosen by the study investigators. All patients will also receive dexamethasone (a steroid commonly used as part of cancer therapy).
Ixazomib is a “proteasome inhibitor” similar to another drug called bortezomib. These drugs inhibit many proteins (known as proteasomes) that cancer cells need to survive and multiply. Unlike bortezomib, which is given intravenously (by vein), ixazomib is taken orally (by mouth). Ixazomib is approved for treating multiple myeloma; its use in this study is considered investigational.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have systemic light chain amyloidosis that persists or has returned despite one or two prior regimens of therapy.
- Patients must be able to be ambulatory for more than half of their normal waking hours.
- This study is open to patients age 18 and older.