2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis
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.
|Multiple Myeloma Plasma Cell Neoplasm||Biological: filgrastim Drug: melphalan Procedure: autologous stem cell transplantation Procedure: stem cell infusion||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Second Autologous Transplantation in AL Amyloidosis|
- 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
|Study Start Date:||August 2001|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: 2nd Stem Cell Transplant
Mobilization with filgrastim autologous stem cell transplantation with melphalan conditioning stem cell infusion
16mcg/kg IV daily beginning three days prior to stem cell collection through last day of stem cell collection
Other Name: G-CSFDrug: melphalan
140-200 mcg/kg IV over two days
Other Name: alkeranProcedure: autologous stem cell transplantation
infusion of previously collected stem cells on Day 0Procedure: stem cell infusion
infusion of previously collected stem cells on Day 0
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075608
|United States, Massachusetts|
|Boston University Cancer Research Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Karen Quillen, MD||Boston Medical Center|