Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies how well stem cell transplant with or without tbo-filgrastim works in treating patients with multiple myeloma or non-Hodgkin lymphoma. Eliminating the use of tbo-filgrastim after transplant may still help maintain a similar time to discharge.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Treatments: Lenograstim

Criteria

Inclusion Criteria:

• Undergoing autologous stem cell transplant for one of the following diagnoses:

• Multiple myeloma

• Non-Hodgkin lymphoma

• Karnofsky performance status of >= 70%

• Patients must meet the Thomas Jefferson University Hospital (TJUH) bone marrow transplant (BMT) standard of procedure (SOP) guidelines for "Patient Criteria for Autologous HSCT"

• Left ventricular ejection fraction (LVEF) of ≥ 40%

• Adjusted Carbon monoxide diffusing capability (DLCO) > 45% of predicted corrected for hemoglobin

• Serum bilirubin < 1.8

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 X 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 and plerixafor as per TJUH BMT SOP guidelines

• Collection of an adequate number of CD34+ stem cells, i.e. >= 4-6 x 10^6/kg from apheresis

Exclusion Criteria:

• Uncontrolled human immunodeficiency virus (HIV)

• Uncontrolled bacterial infection

• Active central nervous system (CNS) disease

• Pregnancy or lactation

• Evidence of another malignancy, exclusive of a skin cancer that requires only local treatment