Mobilization of Stem Cells With AMD3100 (Plerixafor) in Combination With G-CSF in Multiple Myelom… (NCT05087212) | Clinical Trial Compass
CompletedPhase 4
Mobilization of Stem Cells With AMD3100 (Plerixafor) in Combination With G-CSF in Multiple Myeloma Patients
China53 participantsStarted 2021-10-22
Plain-language summary
This is a single-group treatment, phase IV, open label study to assess the mobilization efficacy and safety of plerixafor in combination with G- CSF in male and female participants from 18 to 75 years of age with multiple myeloma for autologous transplantation. Study Duration-Screening-up to 30-day. Intervention and CD34+cells apheresis up-to 8 day. A follow up for 30 days (+7 days) post last dose of plerixafor, or the initiation of ablative chemotherapy, or the first dose of G-CSF administration in rescue procedure, whichever occurs earlier. Study duration up to 75 days. For treatment phase visit frequency-daily.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must be with biopsy-confirmed diagnosis of multiple myeloma before the first mobilization, in first or second complete or partial remission
* The patient is eligible for autologous transplantation and treatment with an autologous peripheral Hematopoietic stem cell (HSC) transplant is planned
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Recovered from all acute toxic effects of prior chemotherapy or other cancer treatment
* Has an actual body weight \<175% of their ideal body weight (IBW)
* In agreement to use an approved form of contraception if of childbearing potential
Exclusion Criteria:
* If they had a comorbid condition which, in the view of the investigators, rendered the patient at high risk from treatment complications
* Active brain metastases or myelomatous meningitis
* Abnormal Electrocardiogram (ECG) with clinically significant rhythm disturbance (ventricular arrhythmias), or other conduction abnormality in the last year that in the opinion of the investigator warrants exclusion of the subject from the trial.
* Active infection requiring antibiotic treatment
* Fever (temperature \> 38°C)
* Positive pregnancy test in female patients
* Lactating females
* Had prior autologous or allogeneic transplantation
* Received bone-seeking radionuclides
* Received \>6 cycles of induction therapy with lenalidomide
* Received \>2 cycles of alkylating agent combinations
* Received more than 2 regimens of alkylating agen…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of patients collecting more than or equal to 6x106 CD34+ cells/kg in 2 or fewer apheresis days