Clinical Trial: Melphalan and Autologous Stem Cell Transplant Followed By Bortezomib and Dexamethasone in Treating Patients With Previously Untreated Systemic Amyloidosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Risk-Adapted Intravenous Melphalan With Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients With Systemic Light-Chain (AL) Amyloidosis
Brief Summary: The purpose of this study in patients needing treatment for AL amyloidosis is to see how well treatment with IV melphalan works and then, if some clonal plasma cells are still present about 2 to 3 months after melphalan treatment, to see how well treatment with bortezomib and dexamethasone works to reduce the rest of the clonal plasma cell disease.
Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center
Current Primary Outcome: Hematologic and Organ Response [ Time Frame: 2-3 months post transplant ]
Original Primary Outcome: Response rate at 12 months
Current Secondary Outcome:
Original Secondary Outcome:
- Toxicity
- Amyloid disease response at 12 and 24 months
- Progression-free survival at 12 and 24 months
- Overall survival at 12 and 24 months
Information By: Memorial Sloan Kettering Cancer Center
Dates:
Date Received: April 9, 2007
Date Started: February 2007
Date Completion:
Last Updated: June 29, 2016
Last Verified: June 2016