Melphalan, Bortezomib, and Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis
RATIONALE: Giving melphalan and bortezomib before and after a stem cell transplant stops the growth of abnormal 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 and monoclonal antibody therapy 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 how well giving melphalan together with bortezomib followed by stem cell transplant works in treating patients with primary systemic amyloidosis.
Procedure: Stem Cell Infusion
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of High-dose Melphalan and Bortezomib and Stem Cell Transplantation in Patients With AL Amyloidosis|
- Hematologic response (complete and partial) [ Time Frame: one year ] [ Designated as safety issue: No ]
- Tolerability [ Time Frame: 100 Days from transplant date ] [ Designated as safety issue: Yes ]
- Survival at 1 and 2 years [ Time Frame: year one and two ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||November 2014|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: SCT with Bortezomib and Melphalan
Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion
16 mcg/kg daily beginning 3 days before SCC through day before final SCC
Other Name: G-CSF, neupogenDrug: bortezomib
1.0 mg/m2/dose D -6, D-3, D +1, D + 4
Other Name: velcadeDrug: melphalan
100 mg/m2/dose D -2, D -1
Other Name: alkeranProcedure: Stem Cell Infusion
infusion of previously collected autologous stem cells
- To determine if hematologic responses to high-dose melphalan and autologous stem cell transplantation increase with addition of bortezomib in the conditioning regimen in patients with primary systemic amyloidosis.
- Autologous stem cell mobilization and collection: Patients receive filgrastim (G-CSF) to mobilize stem cells, which are then collected.
- Conditioning regimen: Patients receive bortezomib IV on days -6, -3, 1, and 4 and oral high-dose melphalan on days -2 and -1.
- Stem cell transplantation: Patients undergo autologous stem cell transplantation on day 0.
After completion of study therapy, patients are followed every 6 months for 1 year and annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790647
|United States, Massachusetts|
|Boston University Cancer Research Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Vaishali Sanchorawala, MD||Boston Medical Center|