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

• Status: Recruiting
• Trial end date: 2023-02-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Plerixafor

Criteria

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

• At least 4 weeks since last cycle of chemotherapy -- Eastern Cooperative Oncology Group performance status of 0 or 1 -- Recovered from all acute toxic effects of prior chemotherapy or other cancer treatment -- 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

• A residual acute medical condition resulting from prior chemotherapy - Had prior autologous or allogeneic transplantation

• 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

• Failed previous hematopoietic stem cell collections or collection attempts

• Received radiation therapy to more than or equal to 50% of the pelvis

• Received specified treatment within specified duration

• Patients whose apheresis product were to be further selected and purified - 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 requirement

• 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

• 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

• Any specific situation during study implementation/course that may rise ethics considerations

• 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