Prospective randomized comparative observation of single- versus split-dose lenograstim to enhance engraftment after autologous stem cell transplantation in patients with multiple myeloma or non-Hodgkin's lymphoma

BACKGROUND: Granulocyte-colony-stimulating factor (G-CSF) is used to enhance hematopoietic recovery after autologous stem cell transplantation (ASCT). Recommendations for administration of G-CSF during the engraftment phase of ASCT have recently changed. This study sought to compare the early engraftment profile between groups receiving single-dose versus split-dose lenograstim to enhance engraftment after ASCT. STUDY DESIGN AND METHODS: A prospective, randomized study was performed with 40 patients (14 with non-Hodgkin's lymphoma, 26 with multiple myeloma) undergoing ASCT. Patients were randomly assigned to receive 5 mu g per kg lenograstim once daily (single dose) or 2.5 mu g per kg lenograstim twice daily (split dose) starting 1 day after transplantation (Day +1). A minimum of 3 x 10(6) per kg CD34+ cells per kg was required for the autograft. RESULTS: The median time to neutrophil engraftment was 10 days for both groups. Platelet (PLT) engraftment was achieved in 11 days for the single-dose group and 14 days for the split-dose group. Episodes of clinically documented infection were low and similar in both groups (18 during 392 patient-days in the single-dose group and 22 during 556 patient-days in the split-dose group). There were no significant differences in requirements for red blood cell or PLT transfusion between the two groups. The duration of hospitalization after stem cell infusion was 18 days for the single-dose group and 22 days for the split-dose group. CONCLUSION: Administration of split doses of lenograstim is not associated with superior clinical efficacy compared with conventional daily single-dose administration for immediate hematopoietic recovery after ASCT.