Multiple Myeloma study: Plerixafor vs Gcsf
Official title Mozobil for Autologous Hematopoietic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT07188090
What this study is testing
What is Plerixafor?
This is an investigational medicine being studied to help collect stem cells for patients with multiple myeloma. It is designed to block a specific receptor to help release stem cells from the bone marrow into the blood.
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
- The study wants to see if using G‑CSF alone, and adding Plerixafor only when needed, can collect enough stem cells while lowering the risk of engraftment syndrome.
- Who it's for
- Adults with multiple myeloma, Hodgkin lymphoma, or non‑Hodgkin lymphoma who are scheduled for an autologous stem‑cell transplant.
- What's involved
- Participants will receive G‑CSF to mobilize stem cells; if the stem‑cell count is low, Plerixafor may be added. Blood tests and stem‑cell collections will be performed, and patients will be monitored for side effects.
- Time commitment
- The study lasts until the stem‑cell collection is complete, typically a few weeks, with several clinic visits for blood draws and monitoring.
- 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
- Age ≥18 years
- Multiple myeloma
- Hodgkin's lymphoma
- Non-Hodgkin lymphoma
- Karnofsky performance status of ≥ 60%
You likely can't join if
- 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
- Age ≥18 years
- 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
- 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
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.