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New treatment option for Multiple Myeloma
Official title Mozobil for Autologous Hematopoietic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT07188090
What this study is testing
What is Plerixafor?
Plerixafor is an investigational medicine, being studied as a potential treatment for multiple myeloma.
Also referred to as Mozobil.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Individuals must meet all of the following 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
You likely can't join if
- 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
See the full eligibility criteria
- Individuals must meet all of the following 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.