Phase 2
Completed N=77
Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma
Non-Hodgkin's Lymphoma · Plasma Cell Myeloma
Source: ClinicalTrials.gov NCT03317899 ↗
Enrolled (actual)
77
Serious AEs
21.1%
Results posted
Dec 2025
Primary outcomePrimary: Number of Days to Discharge — 11; 15 days — p=0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Days to Discharge |
11; 15 | 0.001 sig |
| SECONDARY Median Days Post Autologous Hematopoietic Cell Transplantation (Auto HSCT) to Neutrophil Engraftment |
11; 13 | 0.001 sig |
| SECONDARY Median Days Post Auto HSCT to Platelet Engraftment |
19; 19 | 0.578 |
| SECONDARY Percentage of Participants With Engraftment Syndrome |
48.6; 60 | 0.337 |
| SECONDARY Median Number of Febrile Days During the Auto HSCT Inpatient Stay |
— | — |
| SECONDARY Median Number of Days of Febrile Neutropenia During the Auto HSCT Inpatient Stay |
2; 4 | 0.001 sig |
| SECONDARY Median Number of Documented Infections Treatment During the Auto HSCT Inpatient Stay |
0; 0 | 0.936 |
| SECONDARY Median Number of Antibiotic Days During the Auto HSCT Inpatient Stay |
4; 7 | 0.001 sig |
| SECONDARY Percentage of Participants Receiving Corticosteroids |
31.4; 51.4 | 0.089 |
| SECONDARY Percentage of Participants With Post Discharge Granulocyte Colony-stimulating Factor Administrations Through Day +60 Post Auto HSCT |
5.7; 8.6 | 0.645 |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT03317899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.