Multiple MyelomaPhase 2HSCTNCT07188090
Mozobil for Autologous Hematopoietic Stem Cell Transplantation
A Phase 2 study testing Plerixafor and Gcsf in people with Multiple Myeloma and Hodgkin Lymphoma, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Hodgkin Lymphoma, Non-hodgkin Lymphoma
- What is being tested?
- Plerixafor and Gcsf
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2025to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Xia Bi, MD, MS, 215-955-8874, Xia.Bi@jefferson.edu
About this study
Official title: A Prospective Trial Evaluating Plerixafor-based Mobilization and Risk of Engraftment Syndrome After Autologous Hematopoietic Stem Cell Transplantation
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.
Read the detailed description
This is a prospective, single-arm, open-label clinical trial designed to evaluate the incidence of engraftment syndrome and the efficacy of using granulocyte colonystimulating factor (G-CSF) as the primary agent for stem cell mobilization in patients undergoing autologous stem cell transplantation. The study aims to determine whether selective use of Plerixafor, administered only when necessary, can reduce the incidence of engraftment syndrome compared to a historical rate of 54%, where seventy patients with multiple myeloma or lymphoma were treated with autologous HSCT after stem cell mobilization with GCSF plus plerixafor from 2017-2021 at our institution (27).
All patients will receive G-CSF (peg-filgrastim or filgrastim) starting on day -4, prior to planned peripheral blood stem cell collection on day 0. All patients will proceed with stem cell collection on day 0. Collection will be performed via apheresis, with a collection target of approximately 3 x 106 CD34+ cells/kg of body weight. If less than 1.7 x 106 CD34+ cells/kg is collected after the first day or the target number of stem cells is not reached after two days, Plerixafor will be administered, and additional collection days will be added until the collection goal is reached. The pre-collection CD34+ cell count in peripheral blood will be measured for all participants on day 0 but will not be used to determine whether Plerixafor will be administered. The correlation between pre-collection CD34+ cell count and stem cell collection yield has been well-established (31-33).
The primary objective of the trial is to assess the incidence of engraftment syndrome, defined by clinical symptoms such as fever, rash, and capillary leakage. Incidence of engraftment syndrome will be reported separately for patients who did or did not receive Plerixafor. Secondary objectives include evaluating the efficacy of stem cell mobilization, the time to neutrophil and platelet engraftment post-transplant, the number of collection days required, length of hospital stay, patient disease response, cell composition of the collected product, and cytokine analysis.
Patients will be closely monitored throughout the mobilization and collection process, with routine blood tests performed to assess CD34+ levels, engraftment markers, and any adverse events, including engraftment syndrome. Flow cytometry will be utilized to assess the cellular composition of the collected stem cells, including measurements of CD34+ cells, mononuclear cells, lymphocyte subsets (CD3+, CD4+, CD8+), and NK cells. Additionally, cytokine levels will be measured from each subject prior to stem cell mobilization, day 10, and day 28 post-transplant. These measurements will be analyzed using appropriate assays to investigate their potential roles in the development of engraftment syndrome. The study will provide a comprehensive evaluation of whether limiting Plerixafor use can effectively reduce complications while maintaining sufficient stem cell yield for transplantation.
- Conditions
- Multiple Myeloma, Hodgkin Lymphoma, Non-hodgkin Lymphoma
- Being tested
- Plerixafor, Gcsf
- Keywords
- Engraftment syndrome, stem cell mobilization, autologous stem cell transplant, Plerixafor, G-CSF
- Medical subject headings
- Multiple Myeloma, Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlerixaforDrug
Also called Mozobil
Plerixafor is an antagonist of chemokine receptor-4 (CXCR4) receptor that can release stem cells from the bone marrow niche into the peripheral blood circulation
GcsfDrug
Also called peg-filgrastim, filgrastim
All patients will receive G-CSF (peg-filgrastim or filgrastim) starting on day -4, prior to planned peripheral blood stem cell collection on day 0.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with G-CSF and plerixafor for stem cell mobilization | Experimental | All patients will receive G-CSF (peg-filgrastim or filgrastim) on day -4 prior to planned peripheral blood stem cell (PBSC) collection day 0. All patients will proceed with stem cell collection on day 0. If less than 1.7 x 106 CD34+ cells/kg is collected after the first day or the target number of stem cells is not collected after two days, Plerixafor will be administered, and additional collection days will be added until the collection goal is reached. Receives: Drug: Plerixafor; Drug: Gcsf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Engraftment Syndrome
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.
Measured: 60 days post-autologous stem cell transplant
Secondary outcomes (10)
Efficacy of Stem Cell Mobilization
To determine if G-CSF alone can successfully mobilize a sufficient number of CD34+ stem cells (approximately 3 x 106 cells/kg) in patients undergoing autologous stem cell transplantation, with Plerixafor used only when necessary. Efficacy of Stem Cell Mobilization will be analyzed using descriptive statistics and, where appropriate, survival analysis methods.
Measured: 30 days post-autologous stem cell transplant
Time to Neutrophil Engraftment
To compare the time to engraftment of neutrophils and platelets in patients mobilized with G-CSF alone versus those requiring Plerixafor. Neutrophil engraftment is defined as ANC >500 x10e9/L x 3 days, with day of engraftment the first of the 3 days of ANC >500 x10e9/L. Platelet engraftment is defined as date platelet greater than or equal to (≥) 20 x 10e9 /L which is sustained for 3 consecutive days without a platelet transfusion within the last 7 days. Time-to-event analyses, such as Kaplan-Meier survival curves, will be used to evaluate the time to neutrophil and platelet engraftment.
Measured: Up to 90 days post-transplant
Time to Platelet Engraftment
To compare the time to engraftment of neutrophils and platelets in patients mobilized with G-CSF alone versus those requiring Plerixafor. Neutrophil engraftment is defined as ANC >500 x10e9/L x 3 days, with day of engraftment the first of the 3 days of ANC >500 x10e9/L. Platelet engraftment is defined as date platelet greater than or equal to (≥) 20 x 10e9 /L which is sustained for 3 consecutive days without a platelet transfusion within the last 7 days. Time-to-event analyses, such as Kaplan-Meier survival curves, will be used to evaluate the time to neutrophil and platelet engraftment.
Measured: Up to 90 days post-transplant
Number of Collection Days
To evaluate the average number of collection days needed to achieve the target CD34+ cell count, with and without Plerixafor.
Measured: Up to 90 days post-transplant
Length of Hospital Stay
To examine whether the approach of limiting Plerixafor use influences the duration of the hospital stay for stem cell collection and transplantation.
Measured: Up to 90 days post-transplant
Disease Response
To analyze the patient's response to treatment posttransplantation, including complete response, very good partial response, partial response, stable disease, or progressive disease.
Measured: Up to 90 days post-transplant
Cell Composition
To investigate the composition of the collected stem cell product, particularly focusing on the percentage of CD34+ cells and other relevant immune cell populations via flow cytometry: T cell subsets (CD3+, CD4+, CD8+), B cells, natural killer (NK) cells in patients with and without Plerixafor. Cell composition data will be assessed using paired or independent t-tests, as well as ANOVA, to examine differences between groups.
Measured: Up to 90 days post-transplant
Cytokine Analysis
To measure and analyze cytokine levels in patients, aiming to understand the biological impact of G-CSF with or without Plerixafor on the immune response and mobilization process. Plasma levels for cytokine analysis including ESR, CRP, ferritin, interleukin (IL)-1, IL-1β, IL-2, IL-4, IL-6, interferon (IFN)-γ, tumor necrosis factor (TNF)-α, IL-12, and IL-18 will be measured from each subject prior to stem cell mobilization, day 10, and day 28 post-transplant. Cytokine analysis data will be assessed using paired or independent t-tests, as well as ANOVA, to examine differences between groups.
Measured: At Baseline
Cytokine Analysis
To measure and analyze cytokine levels in patients, aiming to understand the biological impact of G-CSF with or without Plerixafor on the immune response and mobilization process. Plasma levels for cytokine analysis including ESR, CRP, ferritin, interleukin (IL)-1, IL-1β, IL-2, IL-4, IL-6, interferon (IFN)-γ, tumor necrosis factor (TNF)-α, IL-12, and IL-18 will be measured from each subject prior to stem cell mobilization, day 10, and day 28 post-transplant. Cytokine analysis data will be assessed using paired or independent t-tests, as well as ANOVA, to examine differences between groups.
Measured: At Day 10
Cytokine Analysis
To measure and analyze cytokine levels in patients, aiming to understand the biological impact of G-CSF with or without Plerixafor on the immune response and mobilization process. Plasma levels for cytokine analysis including ESR, CRP, ferritin, interleukin (IL)-1, IL-1β, IL-2, IL-4, IL-6, interferon (IFN)-γ, tumor necrosis factor (TNF)-α, IL-12, and IL-18 will be measured from each subject prior to stem cell mobilization, day 10, and day 28 post-transplant. Cytokine analysis data will be assessed using paired or independent t-tests, as well as ANOVA, to examine differences between groups.
Measured: At Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start16 Oct 2025
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xia Bi, MD, MS, Principal investigator, Xia.Bi@jefferson.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188090
- Sponsor's protocol ID
- iRISID-2024-1641
- Other IDs
- JT 44251
- Acronym
- HSCT
- Status last verified
- Nov 2025
- First submitted
- 15 Sep 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial Evaluating Plerixafor-based Mobilization and Risk of Engraftment Syndrome After Autologous Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07188090
- Acronym / sponsor ID
- HSCT / iRISID-2024-1641
- Conditions
- Multiple Myeloma, Hodgkin Lymphoma, Non-hodgkin Lymphoma
- Keywords
- Engraftment syndrome, stem cell mobilization, autologous stem cell transplant, Plerixafor, G-CSF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single-arm, open-label clinical trial designed to evaluate the incidence of engraftment syndrome and the efficacy of using granulocyte colonystimulating factor (G-CSF) as the primary agent for stem cell mobilization in patients undergoing autologous stem cell transplantation. The study aims to determine whether selective use of Plerixafor, administered only when necessary, can reduce the incidence of engraftment syndrome compared to a historical rate of 54%, where seventy patients with multiple myeloma or lymphoma were treated with autologous HSCT after stem cell mobilization with GCSF plus plerixafor from 2017-2021 at our institution (27).
All patients will receive G-CSF (peg-filgrastim or filgrastim) starting on day -4, prior to planned peripheral blood stem cell collection on day 0. All patients will proceed with stem cell collection on day 0. Collection will be performed via apheresis, with a collection target of approximately 3 x 106 CD34+ cells/kg of body weight. If less than 1.7 x 106 CD34+ cells/kg is collected after the first day or the target number of stem cells is not reached after two days, Plerixafor will be administered, and additional collection days will be added until the collection goal is reached. The pre-collection CD34+ cell count in peripheral blood will be measured for all participants on day 0 but will not be used to determine whether Plerixafor will be administered. The correlation between pre-collection CD34+ cell count and stem cell collection yield has been well-established (31-33).
The primary objective of the trial is to assess the incidence of engraftment syndrome, defined by clinical symptoms such as fever, rash, and capillary leakage. Incidence of engraftment syndrome will be reported separately for patients who did or did not receive Plerixafor. Secondary objectives include evaluating the efficacy of stem cell mobilization, the time to neutrophil and platelet engraftment post-transplant, the number of collection days required, length of hospital stay, patient disease response, cell composition of the collected product, and cytokine analysis.
Patients will be closely monitored throughout the mobilization and collection process, with routine blood tests performed to assess CD34+ levels, engraftment markers, and any adverse events, including engraftment syndrome. Flow cytometry will be utilized to assess the cellular composition of the collected stem cells, including measurements of CD34+ cells, mononuclear cells, lymphocyte subsets (CD3+, CD4+, CD8+), and NK cells. Additionally, cytokine levels will be measured from each subject prior to stem cell mobilization, day 10, and day 28 post-transplant. These measurements will be analyzed using appropriate assays to investigate their potential roles in the development of engraftment syndrome. The study will provide a comprehensive evaluation of whether limiting Plerixafor use can effectively reduce complications while maintaining sufficient stem cell yield for transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with G-CSF and plerixafor for stem cell mobilization | Experimental | Drug: Plerixafor, Drug: GcsfAll patients will receive G-CSF (peg-filgrastim or filgrastim) on day -4 prior to planned peripheral blood stem cell (PBSC) collection day 0. All patients will proceed with stem cell collection on day 0. If less than 1.7 x 106 CD34+ cells/kg is collected after the first day or the target number of stem cells is not collected after two days, Plerixafor will be administered, and additional collection days will be added until the collection goal is reached. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
Key exclusion criteria (6 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlerixaforAlso: MozobilPlerixafor is an antagonist of chemokine receptor-4 (CXCR4) receptor that can release stem cells from the bone marrow niche into the peripheral blood circulation | Drug | Treatment with G-CSF and plerixafor for stem cell mobilization |
| GcsfAlso: peg-filgrastim, filgrastimAll patients will receive G-CSF (peg-filgrastim or filgrastim) starting on day -4, prior to planned peripheral blood stem cell collection on day 0. | Drug | Treatment with G-CSF and plerixafor for stem cell mobilization |
Primary outcome
Incidence of Engraftment Syndrome
Time frame: 60 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.
10 secondary outcomes
Efficacy of Stem Cell Mobilization
Time frame: 30 days post-autologous stem cell transplant
Time to Neutrophil Engraftment
Time frame: Up to 90 days post-transplant
Time to Platelet Engraftment
Time frame: Up to 90 days post-transplant
Number of Collection Days
Time frame: Up to 90 days post-transplant
Length of Hospital Stay
Time frame: Up to 90 days post-transplant
Disease Response
Time frame: Up to 90 days post-transplant
Cell Composition
Time frame: Up to 90 days post-transplant
Cytokine Analysis
Time frame: At Baseline
Cytokine Analysis
Time frame: At Day 10
Cytokine Analysis
Time frame: At Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xia Bi, MD, MS principal investigator
Xia.Bi@jefferson.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plerixafor and Gcsf in people with Multiple Myeloma and Hodgkin Lymphoma, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xia Bi, MD, MS (215-955-8874, Xia.Bi@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Engraftment Syndrome (time frame: 60 days post-autologous stem cell transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.