Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilrastim for Neutrophil Recovery After Autotransplant
Sponsored by Hospital Universitario Dr. Jose E. Gonzalez
About this trial
Last updated 2 years ago
Study ID
HE22-00006
Status
Completed
Type
Interventional
Phase
Phase 2
Placebo
No
Accepting
18 to 90 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 2 years ago
What is this trial about?
This is a phase 2 clinical trial comparing time to neutrophil recovery after autotrasplant
using generic pegfilgrastim vs brand-name pegfilgrastim.
What are the participation requirements?
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%)