Clinical Trial: Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic (AL) Amyloidosis

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

Official Title: A Phase II Trial of Tandem Transplantation in AL Amyloidosis

Brief Summary:

RATIONALE: Autologous stem cell transplantation may be effective treatment for primary systemic (AL) amyloidosis.

PURPOSE: This phase II trial is studying how well tandem (two) autologous stem cell transplantation works in treating patients with primary systemic (AL) amyloidosis.


Detailed Summary:

OBJECTIVES:

  • Determine the tolerability of tandem autologous stem cell transplantation in patients with AL amyloidosis.
  • Determine whether this regimen can convert a hematologic non-complete response (CR) to CR in these patients.
  • Determine the overall survival of patients treated with this regimen.

OUTLINE:

  • First transplantation: Patients receive filgrastim (G-CSF) subcutaneously once daily beginning 3 days before the initiation of stem cell collection and continuing until the day before the completion of stem cell collection. Patients may undergo bone marrow harvest if an inadequate number of peripheral blood stem cells are collected.

Patients receive high-dose melphalan IV over 20 minutes on days -3 and -2. Patients undergo autologous stem cell transplantation (ASCT) on day 0.

  • Second transplantation: Within 6-12 months after the first ASCT, patients not achieving a complete response receive high-dose melphalan IV over 20 minutes on days -3 and -2 and a second ASCT on day 0.

Treatment continues in the absence of unacceptable toxicity.

Patients are followed at 3 and 6 months, 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 2-3 years.


Sponsor: Boston Medical Center

Current Primary Outcome: safety [ Time Frame: 100 days, 6 months, and annual ]

Original Primary Outcome:

Current Secondary Outcome: Efficacy [ Time Frame: one year ]

Original Secondary Outcome:

Information By: Boston Medical Center

Dates:
Date Received: January 9, 2004
Date Started: August 2000
Date Completion: May 2018
Last Updated: April 6, 2017
Last Verified: April 2017