Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic (AL) Amyloidosis
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.
Multiple Myeloma and Plasma Cell Neoplasm
Procedure: autologous peripheral blood stem cell transplantation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Tandem Transplantation in AL Amyloidosis|
- safety [ Time Frame: 100 days, 6 months, and annual ] [ Designated as safety issue: Yes ]
- Efficacy [ Time Frame: one year ] [ Designated as safety issue: No ]
|Study Start Date:||August 2000|
|Estimated Study Completion Date:||May 2015|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
All patients will have tandem transplants, unless Complete response is achieved after the first transplant.
16 mg/kg/day for 3 days prior to stem cell collection, through day before last collectionDrug: melphalan
200 mg/kg over 2 days
Other Name: alkeranProcedure: autologous peripheral blood stem cell transplantation
autologous peripheral blood stem cell transplantation
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075621
|United States, Massachusetts|
|Cancer Research Center at Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Vaishali Sanchorawala, MD||Boston Medical Center|