Amyloidosis Clinical Trial
Official title:
Phase II Trial of Induction Therapy With Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation in Patients With AL Amyloidosis
The drugs dexamethasone and bortezomib are both FDA-approved for the treatment of multiple
myeloma, a disease very similar to amyloidosis. However, they are currently investigational
for the treatment of amyloidosis.
We want to find out if the addition of dexamethasone and bortezomib to standard high dose
chemotherapy and stem cell transplant can help improve response.
Standard treatment includes four steps: 1) Stem Cell Mobilization (standard) 2) Stem Cell
Collection (standard) 3) Conditioning Regimen (Melphalan chemotherapy). The conditioning
regimen helps to kill the abnormal cells in the body and makes room in the bone marrow for
new blood stem cells to grow. 4) Stem Cell Infusion
Participants in this study will have an additional treatment step called "induction therapy",
designed as the first step towards reducing the number of abnormal cells in the body. Two
cycles of the investigational drugs bortezomib and dexamethasone will be given during
induction therapy. In addition, bortezomib will given as part of the conditioning regimen, in
addition to the standard melphalan chemotherapy.
The drugs dexamethasone and bortezomib are both FDA-approved drugs for the treatment of
multiple myeloma, a disease very similar to amyloidosis. However, they are currently
investigational for the treatment of amyloidosis.
The investigators want to find out if the addition of dexamethasone and bortezomib to
standard treatment of high dose chemotherapy and stem cell transplant can help improve
response to treatment.
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|---|---|---|---|
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