Determine safety of outpatient chemotherapy and autotransplants using refrigerated, non-frozen grafts in persons with multiple sclerosis.

Abstract

Persons with multiple sclerosis are increasingly treated with intermediate- or high-dose chemotherapy and a hematopoietic cell autotransplant. This is often done in an inpatient setting using frozen blood cell grafts. Determine if chemotherapy and a hematopoietic cell autotransplant can be safely done in an outpatient setting using refrigerated, non-frozen grafts. We developed an autotransplant protocol actionable in an outpatient setting using a refrigerated, non-frozen blood graft collected after giving cyclophosphamide, 50mg/kg/d×2days and filgrastim, 10μg/kg/d. A second identical course was given 9days later followed by infusion of blood cells stored at 4°C for 1-4days. The co-primary outcomes were rates of granulocyte and platelet recovery and therapy-related mortality. We treated 426 consecutive subjects. Median age was 47years (range, 21-68years). A total of 145 (34%) were male. Median graft refrigeration time was 1day (range, 1-4days). Median interval to granulocytes >0.5×10E+9/L was 8days (range, 2-12) and to platelets >20×10E+9/L, 8days (range, 1-12). Only 15 subjects (4%) were hospitalized, predominately for iatrogenic pneumothorax (N=5) and neutropenic fever (N=4). There was only 1 early death from infection. Intermediate-dose chemotherapy and a hematopoietic cell autotransplant can be safely done in an outpatient setting using, refrigerated, non-frozen grafts.