Clinical Trial: HD Melphalan and SCT in Patients With IGDD or LCDD

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

Official Title: High-Dose Melphalan and Autologous Stem Cell Transplantation (HDM/SCT) in Light-Chain Deposition Disease (LCDD) and Immunoglobulin Deposition Disease (IGDD)

Brief Summary:

RATIONALE: Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

PURPOSE: This phase II trial is studying the side effects of high-dose melphalan given together with stem cell transplant and to see how well it works in treating patients with immunoglobulin deposition disease or light-chain deposition disease.


Detailed Summary:

OBJECTIVES:

  • To assess the tolerability of high-dose melphalan and autologous stem cell transplantation in patients with immunoglobulin deposition disease or light-chain deposition disease.
  • To determine the hematologic response rate in patients treated with this regimen.
  • To determine the predictability of early free light-chain response for heme response in patients treated with this regimen.
  • To determine organ or clinical response in patients treated with this regimen.
  • To determine overall survival of these patients.

OUTLINE:

  • Stem cell mobilization: Patients undergo blood stem cell mobilization comprising filgrastim (G-CSF) subcutaneously once daily for 3 days (i.e., through the day before the last stem cell collection).
  • Stem cell collection: Patients undergo collection of G-CSF-mobilized blood stem cells until the target number of stem cells (at least 2 x 10^6 cluster of differentiation-34-positive cells) is reached.
  • Conditioning regimen: Patients receive high-dose melphalan IV on days -3 to -2.
  • Autologous stem cell transplantation: Patients undergo blood stem cell infusion on day 0.

After completion of study therapy, patients are followed at 3, 6, and 12 months and then annually thereafter.


Sponsor: Boston Medical Center

Current Primary Outcome: Hematologic Response Rate [ Time Frame: one year ]

Original Primary Outcome:

  • Tolerability
  • Hematologic Response Rate
  • Predictability of early free light-chain response for heme response
  • Organ or clinical response
  • Overall survival


Current Secondary Outcome:

  • Predictability of Early Free Light-chain Response for Heme Response [ Time Frame: One month ]
  • Organ or Clinical Response [ Time Frame: One year ]
  • Overall Survival [ Time Frame: life ]
  • Tolerability [ Time Frame: 100 days ]


Original Secondary Outcome:

Information By: Boston Medical Center

Dates:
Date Received: May 18, 2008
Date Started: October 2006
Date Completion:
Last Updated: March 28, 2017
Last Verified: March 2017