NCT00075608

2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis

Phase II Trial of Second Autologous Transplantation in AL Amyloidosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma
• Plasma Cell Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim	16mcg/kg IV daily beginning three days prior to stem cell collection through last day of stem cell collection
DRUG	melphalan	140-200 mcg/kg IV over two days
PROCEDURE	autologous stem cell transplantation	infusion of previously collected stem cells on Day 0
PROCEDURE	stem cell infusion	infusion of previously collected stem cells on Day 0

Timeline

• Start date: 2001-08-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2004-01-12
• Last updated: 2017-01-27
• Results posted: 2017-01-27

Locations

1 site across 1 country: United States