Safety and efficacy assessment of plerixafor in patients with multiple myeloma proven or predicted to be poor mobilizers, including assessment of tumor cell mobilization
Tricot G et al. - In a trial to assess the safety and efficacy of plerixafor for stem cell mobilization and tumor cell contamination, it was established that the safety profile of plerixafor in all pts was consistent with previous reports. Methods- This was an open-label, single-center, phase II study of 20 pts with multiple myeloma (MM) who were either proven poor mobilizers (n=10; group A) or predicted poor mobilizers (n=10; group B) and were planned for autologous hematopoietic SCT.
Results- Peripheral blood (PB) CD34+ cell count was generally very low pre- plerixafor and increased significantly post-plerixafor administration.
- Cumulative apheresis yields of ≥2 x 106 CD34+ cells/kg were observed in 7 of 10 pts (group A) and 8 of 10 pts (group B).
- Among the proven poor mobilizers, there was no evidence of tumor cell mobilization in the PB after G-CSF plus plerixafor treatment.
- 17 of 20 (85%) pts underwent transplantation.
- Neutrophil engraftment occurred at a median of 13 days for all pts.
- Platelet engraftment occurred at a median of 16 days and 19 days for all proven and predicted poor mobilizers, respectively.
- At 12 mos, 12 of 17 pts had documented durable grafts, 3 of 17 pts died and 2 of 17 pts were lost to follow-up; but they had documented graft durability at the previous 3- and 6-mo visit.
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