Conditions: Multiple Myeloma Plasma Cell Neoplasm
Keywords: primary systemic amyloidosis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 12
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Mobilization with filgrastim autologous stem cell transplantation with melphalan conditioning stem cell infusion

Interventions: intervention 1: filgrastim intervention 2: melphalan intervention 3: autologous stem cell transplantation intervention 4: stem cell infusion
Intervention descriptions: intervention 1: 16mcg/kg IV daily beginning three days prior to stem cell collection through last day of stem cell collection intervention 2: 140-200 mcg/kg IV over two days intervention 3: infusion of previously collected stem cells on Day 0 intervention 4: infusion of previously collected stem cells on Day 0

Protocol document: