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

Phase 2

Completed

• Conditions: Myeloma Multiple; Lymphoma
• Interventions: Drug: Pegfilgrastim

• Registration Number: NCT05338047
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

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.

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-20
• Status Verified: 2023-02
• Primary Completion: 2023-02-25
• Study Completion: 2023-02-25
• Last Update Submitted: 2023-02-25
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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%)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brand name pegfilgrastim	Pegfilgrastim	One 6mg subcutaneous dose of brand name pegfilgrastim in day+1 after autotransplant
Generic pegfilgrastim	Pegfilgrastim	One 6mg subcutaneous dose of generic pegfilgrastim in day+1 after autotransplant

Primary Outcome Measures

Name	Time	Method
Time to neutrophil recovery	15 days	Time from autologous transplant to neutrophil count \>0.5x10\^3/microL

Secondary Outcome Measures

Name	Time	Method
Time to platelet recovery	15 days	Time from autologous transplant to platelet count \>20x10\^3/microL

Trial Locations

Locations (1)

Hospital Universitario Dr. José Eleuterio González; 🇲🇽 Monterrey, Nuevo León, Mexico