Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or… (NCT03317899) | Clinical Trial Compass
CompletedPhase 2
Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma
United States77 participantsStarted 2017-10-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* Uncontr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared stem cell transplants with and without tbo-filgrastim for multiple myeloma or non-Hodgkin lymphoma — since it's already completed, has the data been published, and what did it show about how quickly patients were discharged from the hospital?
2The main thing this Phase 2 trial was measuring was how many days it took patients to be discharged after transplant — does a shorter hospital stay translate into a real benefit for my specific situation, or are there other factors I should weigh more heavily?
3Since this was a Phase 2 trial, what does that mean for how confident we can be in the safety and effectiveness of adding tbo-filgrastim to a stem cell transplant, and would a larger Phase 3 study be needed before this becomes a standard approach?
4Is a stem cell transplant the right path for me right now given my diagnosis of either multiple myeloma or non-Hodgkin lymphoma, or should we consider standard treatments first before thinking about transplant-based options?
5If the completed results from this trial look promising, is tbo-filgrastim in combination with a stem cell transplant something you would consider recommending for my care, and are there other ongoing trials with similar approaches I might be eligible for?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Days to Discharge
Timeframe: Up to 60 days
Trial details
NCT IDNCT03317899
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University