Clinical trial NCT05338047: Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilrastim for Neutrophil Recovery After Autotransplant
Official title: Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilgrastim for Neutrophil Recovery After Autologous Stem Cell Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myeloma Multiple
Lymphoma
Keywords: Autotransplant
Neutrophil recovery
Pegfilgrastim
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility 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%)

Primary outcomes:
measure: Time to neutrophil recovery
timeFrame: 15 days
Secondary outcomes:
measure: Time to platelet recovery
timeFrame: 15 days
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. José Eleuterio González
state: Nuevo León
Study officials:
affiliation: Hospital Universitario
name: Cesar H Gutierrez Aguirre
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jagasia MH, Greer JP, Morgan DS, Mineishi S, Kassim AA, Ruffner KL, Chen H, Schuening FG. Pegfilgrastim after high-dose chemotherapy and autologous peripheral blood stem cell transplant: phase II study. Bone Marrow Transplant. 2005 Jun;35(12):1165-9. doi: 10.1038/sj.bmt.1704994.
citation: Sheth V, Gore A, Jain R, Ghanekar A, Saikia T. Pegfilgrastim: More Cost Effective and Equally Efficacious Option as Compared to Filgrastim in Autologous Stem Cell Transplant. Indian J Hematol Blood Transfus. 2019 Jan;35(1):66-71. doi: 10.1007/s12288-018-0966-5. Epub 2018 May 17.