About the study

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 take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Participants must be with biopsy-confirmed diagnosis of multiple myeloma before the first mobilization, in first or second complete or partial remission
2. The patient is eligible for autologous transplantation and treatment with an autologous peripheral Hematopoietic stem cell (HSC) transplant is planned
3. Eastern Cooperative Oncology Group performance status of 0 or 1
4. Recovered from all acute toxic effects of prior chemotherapy or other cancer treatment
5. Has an actual body weight <175% of their ideal body weight (IBW)
6. In agreement to use an approved form of contraception if of childbearing potential

Exclusion criteria

1. If they had a comorbid condition which, in the view of the investigators, rendered the patient at high risk from treatment complications
2. Active brain metastases or myelomatous meningitis
3. 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.
4. Active infection requiring antibiotic treatment
5. Fever (temperature > 38°C)
6. Positive pregnancy test in female patients
7. Lactating females
8. Had prior autologous or allogeneic transplantation
9. Received bone-seeking radionuclides
10. Received >6 cycles of induction therapy with lenalidomide
11. Received >2 cycles of alkylating agent combinations
12. Received more than 2 regimens of alkylating agent combinations
13. Were less than 6 weeks off 1,3-bis(2-chloroethyl)-1
14. nitrosourea (BCNU) before first dose of G-CSF
15. Were less than 4 weeks off last cycle of chemotherapy before first dose of G-CSF
16. Failed previous hematopoietic stem cell collections or collection attempts
17. Received radiation therapy to more than or equal to 50% of the pelvis
18. Received specified treatment within specified duration.
19. Patients whose apheresis product were to be further selected and purified
20. 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
21. Had previously received experimental therapy within 4 weeks of enrolling or currently enrolled in another experimental protocol
22. 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
23. Positive test for HIV, active Hepatitis B (HBV), or active Hepatitis C (HCV) within 30 days prior to the first dose of IMP
24. Has active central nervous system involvement
25. Individuals accommodated in an institution because of regulatory or legal order; prisoners or subjects who are legally institutionalized
26. 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
27. Participants are dependent on the Sponsor or Investigator
28. Any specific situation during study implementation/course that may rise ethics considerations
29. 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.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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