Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilrastim for Neutrophil Recovery After Autotransplant

Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilgrastim for Neutrophil Recovery After Autologous Stem Cell Transplant

This is a phase 2 clinical trial comparing time to neutrophil recovery after autotrasplant using generic pegfilgrastim vs brand-name pegfilgrastim.

Thirty consecutive adults with lymphoma or myeloma receiving autologous peripheral blood stem cell transplant will be included in this phase 2 clinical trial. Patients will be allocated 1:1 in two groups: one subcutaneous 6 mg dose of generic pegfilgrastim (control group) or one 6mg dose of brand-name pegfilgrastim (intervention group) both at day +1 after the autotransplant. Daily complete blood counts were collected and time to neutrophil (>0.5x10^3/microL) and platelet recovery (>20x10^3/microL) will be obtained. The investigators will describe the proportion of adverse events and median time to neutrophil and platelet recoveries. Median or mean time to neutrophil recovery and time to platelet recovery will be calculated and compared with Mann-Whitney-Wilcoxon test or student T.

Inclusion Criteria:

• Patients undergoing autologous peripheral blood stem cell transplantation
• Patients with multiple myeloma or lymphoma
• Adults (>18 years)
• Both genders
• Eastern Cooperative Oncology Group (ECOG) <=2

Exclusion Criteria:

• Alanine Aminotransferase or bilirubin values >2.5 times the superior normal limit
• Creatinin >2.2mg/dL
• Fever >37.6°C
• Active infection
• Hepatitis B, C or HIV infection
• Congestive heart failure (ejection fraction <40%)