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Mozobil for Autologous Stem Cell Transplantation in Myeloma and Lymphoma

This study is looking at a new way to collect stem cells for patients with multiple myeloma, Hodgkin lymphoma, or non-Hodgkin lymphoma who are having an autologous stem cell transplant (using your own stem cells). It tests if using G-CSF (a drug to help release stem cells) by itself, with Plerixafor (another stem cell-releasing drug) only if needed, can help collect enough stem cells. The main goal is to see if this approach can reduce a side effect called engraftment syndrome. You can join if you are 18 or older and meet specific health criteria. The study aims to enroll 100 participants, but its current recruitment status is unclear.

Study design
This is a single-arm, open-label study, meaning all participants receive the same treatment and both you and the study team will know which treatment you are getting. It plans to include 100 participants.
What's involved
You will receive G-CSF starting four days before your stem cell collection. Stem cell collection will happen on day 0, and if not enough cells are collected, you might receive Plerixafor and have additional collection days.
Compensation
Not stated in the trial record.
Follow-up
The main outcome, engraftment syndrome, will be measured 60 days after your autologous stem cell transplant.

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NCT07188090

Mozobil for Autologous Hematopoietic Stem Cell Transplantation

Recruiting
PHASE2Ages 18+InterventionalTreatment
Thomas Jefferson University
~100 participants
Updated 2025-11-28 on ClinicalTrials.gov
What's tested:PlerixaforGcsf

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Engraftment Syndrome
Measured over 60 days post-autologous stem cell transplant

Conditions

Multiple Myeloma
Hodgkin Lymphoma
Non-hodgkin Lymphoma

Explore related trials

Hodgkin's GranulomaMultiple MyelomaNon-Hodgkin Lymphoma

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

Who to contact

Xia Bi, MD, MS
[email protected]
215-955-8874
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of Engraftment Syndrome60 days post-autologous stem cell transplant

    ES will be defined as per Maiolino criteria (1) as a new fever \>100.4 F without clinical or microbiological documentation of infection plus at least 1 other criteria: (1) skin rash, (2) pulmonary infiltrates in the absence of cardiac failure, pulmonary embolism, or infection, or (3) 2 or more episodes of diarrhea a day. Clinical signs of ES have to occur within 24 hours before or after the first appearance of neutrophils in the peripheral blood.