Clinical Trial: 2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase II Trial of Second Autologous Transplantation in AL Amyloidosis

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher doses of chemotherapy to be given so that more plasma cells are killed. By reducing the number of plasma cells, the disease may progress more slowly.

PURPOSE: This phase II trial is studying how well autologous stem cell transplant works in treating patients with persistent or recurrent primary systemic (AL) amyloidosis.


Detailed Summary:

OBJECTIVES:

  • Determine the feasibility and tolerability of second autologous stem cell transplantation in patients with persistent or recurrent AL amyloidosis.
  • Determine the response rate and durability of response in patients treated with this regimen.
  • Determine immune reconstitution in patients treated with this regimen.

OUTLINE:

  • Mobilization: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning before the initiation of stem cell collection and continuing until the day before the completion of stem cell collection.
  • Preparative regimen: Patients receive high-dose melphalan IV over 20 minutes on days -3 and -2.
  • Autologous stem cell transplantation: Autologous stem cells are reinfused on day 0.

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

PROJECTED ACCRUAL: A total of 19 patients will be accrued for this study within 5-6 years.


Sponsor: Boston Medical Center

Current Primary Outcome:

  • Feasibility and Tolerability [ Time Frame: 3 months after treatment and annually ]
    Feasibility and tolerability will be evaluated based on participants completing second transplant with tolerable adverse events
  • Response and Durability of Response [ Time Frame: 3 months after treatment and annually ]
    Response and durability of response will be based on hematologic Complete Response or Partial Response and date of relapse or death
  • Evaluate Immune Reconstitution [ Time Frame: 3 months after treatment and annually ]
    Evaluate immune reconstitution based on time to engraftment


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Boston Medical Center

Dates:
Date Received: January 9, 2004
Date Started: August 2001
Date Completion:
Last Updated: December 2, 2016
Last Verified: December 2016