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

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

Detailed Description
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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.

Official Title
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Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilgrastim for Neutrophil Recovery After Autologous Stem Cell Transplant

Conditions
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Myeloma Multiple, Lymphoma

Intervention / Treatment
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* Drug: Pegfilgrastim


Participation Criteria
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Eligibility Criteria
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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%)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Generic pegfilgrastim<br>One 6mg subcutaneous dose of generic pegfilgrastim in day+1 after autotransplant | Drug: Pegfilgrastim<br>* Single 6mg dose of generic pegfilgrastim or brand name pegfilgrastim, at day +1 after autotransplant.<br>* Other names: Linkix;|
| Active Comparator: Brand name pegfilgrastim<br>One 6mg subcutaneous dose of brand name pegfilgrastim in day+1 after autotransplant | Drug: Pegfilgrastim<br>* Single 6mg dose of generic pegfilgrastim or brand name pegfilgrastim, at day +1 after autotransplant.<br>* Other names: Linkix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to neutrophil recovery | Time from autologous transplant to neutrophil count >0.5x10^3/microL | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to platelet recovery | Time from autologous transplant to platelet count >20x10^3/microL | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autotransplant, Neutrophil recovery, Pegfilgrastim