Clinical trial · Interventional
Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma
A Randomized Controlled Trial Evaluating the Use of G-CSF After Plerixafor-Mobilized Autologous Stem Cell Transplant (Auto HSCT)
NCT03317899CI-TRIAL-00099138completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Plasma Cell Myeloma | Multiple Myeloma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hematopoietic Cell Transplantation | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Tbo-filgrastim | Drug | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (auto HSCT tbo-filgrastim)
- description
- Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days.
- interventionNames
- Procedure: Hematopoietic Cell Transplantation
- Drug: Tbo-filgrastim
- Other: Laboratory Biomarker Analysis
- type
- EXPERIMENTAL
- label
- Group II (auto HSCT)
- description
- Patients undergo auto Hematopoietic Cell Transplantation (HSCT).
- interventionNames
- Procedure: Hematopoietic Cell Transplantation
- Other: Laboratory Biomarker Analysis
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.