A Prospective Trial Evaluating Plerixafor-based Mobilization and Risk of Engraftment Syndrome After Autologous Hematopoietic Stem Cell Transplantation
This prospective trial investigates the approach of G-CSF with risk-adapted Plerixafor use for stem cell mobilization in patients undergoing autologous stem cell transplantation. Since FDA approval in 2008, Plerixafor has been combined with G-CSF to mobilize stem cells, though this regimen has been associated with a potentially higher incidence of engraftment syndrome. The trial aims to evaluate whether using G-CSF alone, with selective use of Plerixafor, can achieve adequate stem cell collection while possibly reducing the incidence of engraftment syndrome.
• Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
‣ Age ≥18 years
⁃ Undergoing autologous stem cell transplant for one of the following diagnoses:
• Multiple myeloma
∙ Hodgkin's lymphoma
∙ Non-Hodgkin lymphoma
⁃ Karnofsky performance status of ≥ 60%
⁃ Patients must meet the TJUH BMT SOP guidelines for Patient Criteria for Autologous HSCT as specified below
⁃ Adequate organ function:
• LVEF of ≥40%
∙ Adjusted DLCO ≥45% of predicted corrected for hemoglobin
⁃ Adequate liver function as defined by a serum bilirubin \<1.8, AST or ALT \< 2.5X upper limit of normal
⁃ Serum creatinine ≤ 2.0 mg/dl and/or creatinine clearance of \> 40 ml/min (excludes multiple myeloma patients receiving high dose Melphalan conditioning)
⁃ Willingness to use contraception if childbearing potential
⁃ Has the ability to give informed consent, or for cognitively or decisionally impaired individuals (vulnerable population), the availability of a family member or guardian to give consent and assist in the consent process
⁃ Life expectancy of \> 12 months (exclusive of the disease for which the Auto HSCT is being performed)
⁃ Patients must have undergone stem cell mobilization with the combination of G- CSF or biosimilars with plerixafor or G-CSF or biosimilars alone