AL Amyloidosis Clinical Trial
Official title:
Phase II Study of the Combination of Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis
The study is being done to see if the combination of bendamustine and dexamethasone will help people with amyloidosis that has returned after standard treatment, and to to estimate the partial hematologic response rate (PHR).
Systemic light-chain amyloidosis (AL) is a protein conformation disorder due to a clonal
plasma cell dyscrasia. There are no established and approved second-line therapies for
patients with systemic AL amyloidosis who fail initial melphalan-based treatment, be it
high-dose melphalan with stem cell transplant or oral melphalan and dexamethasone (MDex).
Therefore new treatments are needed for those who fail initial therapy and for those who
initially respond but subsequently relapse.
Therapy of AL is generally based on treatment regimens used in multiple myeloma (MM).
Bendamustine achieves partial response with relapsed/refractory MM. Based on this high
anti-MM activity, we anticipate that bendamustine will also be very active in clonal plasma
cell disorder associated with AL.
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