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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
16mcg/kg IV daily beginning three days prior to stem cell collection through last day of stem cell collection
140-200 mcg/kg IV over two days
infusion of previously collected stem cells on Day 0
infusion of previously collected stem cells on Day 0
Boston University Cancer Research Center
Boston, Massachusetts, United States
Feasibility and Tolerability
Feasibility and tolerability will be evaluated based on participants completing second transplant with tolerable adverse events
Time frame: 3 months after treatment and annually
Response and Durability of Response
Response and durability of response will be based on hematologic Complete Response or Partial Response and date of relapse or death
Time frame: 3 months after treatment and annually
Evaluate Immune Reconstitution
Evaluate immune reconstitution based on time to engraftment
Time frame: 3 months after treatment and annually
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