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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase

Completed

Phase 2

Conditions

Plasma Cell Myeloma

Non-Hodgkin's Lymphoma

Treatments

Drug: Tbo-filgrastim

Other: Laboratory Biomarker Analysis

Procedure: Hematopoietic Cell Transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT03317899

JT 10928 (Other Identifier)

17D.404

Details and patient eligibility

About

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.

Full 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 transplant in patients receiving versus not receiving post-transplant growth factor support.

SECONDARY OBJECTIVE:

I. To compare days to absolute neutrophil count (ANC) > 500, days to platelet engraftment, febrile days, days of febrile neutropenia, documented infections, and number of antibiotic days in patients receiving versus not receiving post-transplant growth factor support.

EXPLORATORY OBJECTIVE:

I. To evaluate immunological recovery (lymphocyte number including CD 3/4 and CD3/8 T cell subsets) at day + 60 in patients receiving versus not receiving post-transplant growth factor support.

Enrollment

77 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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