NCT07188090 Mozobil for Autologous Hematopoietic Stem Cell Transplantation
| NCT ID | NCT07188090 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Thomas Jefferson University |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-10-16 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-10-16 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This prospective trial investigates the approach of G-CSF with risk-adapted Plerixafor use for stem cell mobilization in patients undergoing autologous stem cell transplantation. Since FDA approval in 2008, Plerixafor has been combined with G-CSF to mobilize stem cells, though this regimen has been associated with a potentially higher incidence of engraftment syndrome. The trial aims to evaluate whether using G-CSF alone, with selective use of Plerixafor, can achieve adequate stem cell collection while possibly reducing the incidence of engraftment syndrome.
Eligibility Criteria
Inclusion Criteria: * Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study: * Age ≥18 years * Undergoing autologous stem cell transplant for one of the following diagnoses: * Multiple myeloma * Hodgkin's lymphoma * Non-Hodgkin lymphoma * Karnofsky performance status of ≥ 60% * Patients must meet the TJUH BMT SOP guidelines for "Patient Criteria for Autologous HSCT" as specified below * Adequate organ function: * LVEF of ≥40% * Adjusted DLCO ≥45% of predicted corrected for hemoglobin * Adequate liver function as defined by a serum bilirubin \<1.8, AST or ALT \< 2.5X 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 or biosimilars with plerixafor or G-CSF or biosimilars alone Exclusion Criteria: * An individual who meets any of the following criteria will be excluded from participation in this study: * Uncontrolled HIV * Uncontrolled bacterial infection * Active CNS disease * Pregnancy or lactation * Evidence of another malignancy, exclusive of a skin cancer that requires only local treatment
Contact & Investigator
Xia Bi, MD, MS
PRINCIPAL INVESTIGATOR
Xia.Bi@jefferson.edu
Frequently Asked Questions
Who can join the NCT07188090 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07188090 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07188090 currently recruiting?
Yes, NCT07188090 is actively recruiting participants. Contact the research team at Xia.Bi@jefferson.edu for enrollment information.
Where is the NCT07188090 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT07188090 clinical trial?
NCT07188090 is sponsored by Thomas Jefferson University. The principal investigator is Xia Bi, MD, MS at Xia.Bi@jefferson.edu. The trial plans to enroll 100 participants.