Status:
COMPLETED
Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Conditions:
Non-Hodgkin's Lymphoma
Plasma Cell Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
PRIMARY OBJECTIVE: I. To demonstrate non-inferiority in the number of days to discharge readiness after a granulocyte colony-stimulating factor (G-CSF) + plerixafor-mobilized autologous stem cell tra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2022
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT03317899
Start Date
October 12 2017
End Date
November 16 2022
Last Update
December 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107