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

Primary Purpose

Myeloma Multiple, Lymphoma

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Pegfilgrastim
Sponsored by
Hospital Universitario Dr. Jose E. Gonzalez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myeloma Multiple focused on measuring Autotransplant, Neutrophil recovery, Pegfilgrastim

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%)

Sites / Locations

  • Hospital Universitario Dr. José Eleuterio González

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Generic pegfilgrastim

Brand name pegfilgrastim

Arm Description

One 6mg subcutaneous dose of generic pegfilgrastim in day+1 after autotransplant

One 6mg subcutaneous dose of brand name pegfilgrastim in day+1 after autotransplant

Outcomes

Primary Outcome Measures

Time to neutrophil recovery
Time from autologous transplant to neutrophil count >0.5x10^3/microL

Secondary Outcome Measures

Time to platelet recovery
Time from autologous transplant to platelet count >20x10^3/microL

Full Information

First Posted
April 12, 2022
Last Updated
February 25, 2023
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
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1. Study Identification

Unique Protocol Identification Number
NCT05338047
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
February 25, 2023 (Actual)
Study Completion Date
February 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Dr. Jose E. Gonzalez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloma Multiple, Lymphoma
Keywords
Autotransplant, Neutrophil recovery, Pegfilgrastim

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Generic pegfilgrastim
Arm Type
Placebo Comparator
Arm Description
One 6mg subcutaneous dose of generic pegfilgrastim in day+1 after autotransplant
Arm Title
Brand name pegfilgrastim
Arm Type
Active Comparator
Arm Description
One 6mg subcutaneous dose of brand name pegfilgrastim in day+1 after autotransplant
Intervention Type
Drug
Intervention Name(s)
Pegfilgrastim
Other Intervention Name(s)
Neulasta, Linkix
Intervention Description
Single 6mg dose of generic pegfilgrastim or brand name pegfilgrastim, at day +1 after autotransplant.
Primary Outcome Measure Information:
Title
Time to neutrophil recovery
Description
Time from autologous transplant to neutrophil count >0.5x10^3/microL
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Time to platelet recovery
Description
Time from autologous transplant to platelet count >20x10^3/microL
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesar H Gutierrez Aguirre
Organizational Affiliation
Hospital Universitario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Dr. José Eleuterio González
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
66260
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15880129
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.
Results Reference
result
PubMed Identifier
30828150
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.
Results Reference
result

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

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