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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2023
  • participants needed
    30
  • sponsor
    Hospital Universitario Dr. Jose E. Gonzalez
Updated on 2 May 2022
lymphoma
multiple myeloma
cell transplantation

Summary

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

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.

Details
Condition Myeloma Multiple, Lymphoma
Treatment pegfilgrastim
Clinical Study IdentifierNCT05338047
SponsorHospital Universitario Dr. Jose E. Gonzalez
Last Modified on2 May 2022

Eligibility

Yes No Not Sure

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%)
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