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

Hospital Universitario Dr. Jose E. Gonzalez

Status and phase

Completed

Phase 2

Conditions

Myeloma Multiple

Lymphoma

Treatments

Drug: Pegfilgrastim

Study type

Interventional

Funder types

Other

Identifiers

NCT05338047

HE22-00006

Details and patient eligibility

About

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

Full description

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.

Enrollment

30 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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%)