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Completed

NCT Number: NCT05338047

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

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

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Key information

Conditions

Myeloma Multiple Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitario Dr. José Eleuterio González

Monterrey, Nuevo León, 66260, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

pegfilgrastim

Drug

Single 6mg dose of generic pegfilgrastim or brand name pegfilgrastim, at day +1 after autotransplant.

Other names: Neulasta, Linkix

Primary outcomes

  1. Time to neutrophil recovery

    Time frame: 15 days

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

Secondary outcomes

  1. Time to platelet recovery

    Time frame: 15 days

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

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2022
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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