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 range18 Years – 75 Years
SexALL
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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…
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