Clinical Trial: Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL Amyloidosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Pilot Study of Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Depositio

Brief Summary: The goal of this clinical trial is to determine the toxicity and also the efficacy of a treatment that includes the following treatment: Two medications, bortezomib and dexamethasone (or BD), followed by autologous stem cell transplantation, and a prolonged course of treatment with bortezomib and dexamethasone after transplantation. This type of treatment has been very effective in multiple myeloma. However, there is little experience with this treatment in patients who have Monoclonal Immunoglobulin Deposition Disease (MIDD) or amyloidosis. The investigators and others have treated patients who have MIDD and amyloidosis with bortezomib and autologous stem cell transplantation and have had success with this treatment. But the combination of autologous transplant with BD given before and after the transplant is a new way of treating these diseases, which the investigators believe will be very effective.

Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome:

• To examine the tolerability [ Time Frame: 2 years ]
  of a 3-phase comprehensive treatment approach including induction with BD followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with MIDD and AL amyloidosis.
• To examine the toxicity [ Time Frame: 2 years ]
  Toxicities will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. Safety measurements also will be evaluated by physical examination findings, vital signs assessments, clinical laboratory test results, and adverse events.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• To estimate the hematologic response rate [ Time Frame: 2 years ]
  [Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)], achieved at 12 month, and at 24 months post-initiation of treatment following the 3-phase comprehensive treatment approach
• To estimate the organ response rate [ Time Frame: 2 years ]
  12 months and at 24 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with MIDD and AL amyloidosis.
• To estimate the time to hematologic progression [ Time Frame: 2 years ]
  following the 3-phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with MIDD and AL amyloidosis.

Original Secondary Outcome:

• To estimate the hematologic response rate [ Time Frame: 2 years ]
  [Complete Response (CR), near Complete Response (nCR) and Partial Response (PR)], achieved at the end of therapy, and at 24 months post-initiation of treatment following the 3-phase comprehensive treatment approach
• To estimate the organ response rate at the end of treatment [ Time Frame: 2 years ]
  and at 24 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with MIDD and AL amyloidosis.
• To estimate the time to hematologic progression [ Time Frame: 2 years ]
  following the 3-phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with MIDD and AL amyloidosis.

Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: June 27, 2011
Date Started: June 24, 2011
Date Completion: June 2018
Last Updated: May 10, 2017
Last Verified: May 2017