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 ]

patients will be assessed for hematologic response (the response of the clonal plasma cell disease). If the plasma cell disease persists, then they will receive 6 cycles of adjuvant therapy with bortezomib and dexamethasone; patients with peripheral neuropathy will receive dexamethasone alone because of the risk of neuropathy associated with bortezomib. Symptomatic organ involvement with amyloid as defined below. Patients must have symptomatic involvement of no more than 2 of the following 4 visceral organ-systems: kidneys, liver/GI, peripheral/autonomic nervous system, and heart.


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