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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
30
Single 6mg dose of generic pegfilgrastim or brand name pegfilgrastim, at day +1 after autotransplant.
Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo León, Mexico
Time to neutrophil recovery
Time from autologous transplant to neutrophil count \>0.5x10\^3/microL
Time frame: 15 days
Time to platelet recovery
Time from autologous transplant to platelet count \>20x10\^3/microL
Time frame: 15 days
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