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

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Criteria

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%)