Mobilization of Stem Cells With AMD3100 (Plerixafor) in Combination With G-CSF in Multiple Myeloma Patients

  • STATUS
    Recruiting
  • End date
    Feb 2, 2023
  • participants needed
    48
  • sponsor
    Sanofi
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Updated on 13 May 2022
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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.

Description

The study duration consists of: An up-to 30-day screening, an up-to 8-day intervention and CD34+ cells apheresis and 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

Details
Condition Autologous Haematopoietic Stem Cell Transplant
Treatment plerixafor + G-CSF
Clinical Study IdentifierNCT05087212
SponsorSanofi
Last Modified on13 May 2022

Eligibility

 Yes No Not Sure

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
Received bone-seeking radionuclides
Received more than 2 regimens of alkylating agent combinations
Were less than 6 weeks off 1,3-bis(2-chloroethyl)-1- nitrosourea (BCNU) before first dose of G-CSF
Active brain metastases or myelomatous meningitis
Failed previous hematopoietic stem cell collections or collection attempts
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
Received radiation therapy to more than or equal to 50% of the pelvis
Active infection requiring antibiotic treatment
Received specified treatment within specified duration
Fever (temperature > 38°C)
Positive pregnancy test in female patients
Lactating females
Had prior autologous or allogeneic transplantation
Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
Participants are dependent on the Sponsor or Investigator
Received >6 cycles of induction therapy with lenalidomide
Any specific situation during study implementation/course that may rise ethics considerations
Received >2 cycles of alkylating agent combinations
Were less than 4 weeks off last cycle of chemotherapy before first dose of G-CSF
Patients whose apheresis product were to be further selected and purified
Has received a live vaccine within 30 days of the planned start of study therapy. Seasonal flu vaccines that do not contain live virus are permitted
Had previously received experimental therapy within 4 weeks of enrolling or currently enrolled in another experimental protocol
White blood cell (WBC) count, Absolute neutrophil count (ANC)PLT count, estimated creatinine clearance, Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin should meet protocol requirements
Positive test for HIV, active Hepatitis B (HBV), or active Hepatitis C (HCV) within 30 days prior to the first dose of IMP
Has active central nervous system involvement
Individuals accommodated in an institution because of regulatory or legal order; prisoners or subjects who are legally institutionalized
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
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