Plerixafor plus pegfilgrastim is a safe, effective mobilization regimen for poor or adequate mobilizers of hematopoietic stem and progenitor cells: a phase I clinical trial.

Abstract

The safety, kinetics and efficacy of plerixafor+pegfilgrastim for hematopoietic stem and progenitor cell (HSPC) mobilization are poorly understood. We treated 12 study patients (SP; lymphoma n=10 or myeloma n=2) with pegfilgrastim (6 mg SC stat D1) and plerixafor (0.24 mg/kg SC nocte from D3). Six SP were 'predicted poor-mobilizers' and six were 'predicted adequate-mobilizers'. Peripheral blood (PB) CD34(+) monitoring commenced on D3. Apheresis commenced on D4. Comparison was with 22 historical controls (HC; lymphoma n=18, myeloma n=4; poor mobilizers n=4), mobilized with pegfilgrastim alone. Eight (67%) SP had PB CD34(+) count ⩽5 × 10(6)/L D3 post pegfilgrastim; all SP surpassed this threshold the morning after plerixafor. In SP, PBCD34(+) counts peaked D4 6/12 (50%), remaining ⩾5 × 10(6)/L for 4 days in 8/12 (67%). All SP successfully yielded target cell numbers (⩾2 × 10(6)/kg) within four aphereses. After maximum four aphereses, median total CD34+ yield was higher in SP than HC; 8.0 (range 2.4-12.9) vs 4.8 (0.4-14.0) × 10(6)/kg (P=0.04). Seven of twelve (58%) SP achieved target yield after one apheresis. Flow cytometry revealed no tumor cells in PB or apheresis product of SP. Plerixafor+pegfilgrastim was well tolerated with bone pain (n=2), diarrhoea (n=2) and facial paraesthesiae (n=3). Plerixafor+pegfilgrastim is a simple, safe and effective HSPC mobilization regimen in myeloma and lymphoma, in both poor and good mobilizers, and is superior to pegfilgrastim alone.

• Authors: K E Herbert, L Demosthenous, G Wiesner, E Link, D A Westerman, N Came, D S Ritchie, S Harrison, J F Seymour, H M Prince
• Journal: Bone marrow transplantation (Bone Marrow Transplant) Vol. 49 Issue 8 Pg. 1056-62 (Aug 2014) ISSN: 1476-5365 [Electronic] England
• PMID: 24887382 (Publication Type: Clinical Trial, Phase I, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-HIV Agents
• Benzylamines
• Cyclams
• Heterocyclic Compounds
• Recombinant Proteins
• Granulocyte Colony-Stimulating Factor
• pegfilgrastim
• Polyethylene Glycols
• Filgrastim
• plerixafor

Topics

• Adult
• Anti-HIV Agents (administration & dosage)
• Autografts
• Benzylamines
• Blood Component Removal (methods)
• Cyclams
• Female
• Filgrastim
• Granulocyte Colony-Stimulating Factor (administration & dosage)
• Hematopoietic Stem Cell Mobilization (methods)
• Heterocyclic Compounds (administration & dosage)
• Humans
• Lymphoma (therapy)
• Male
• Middle Aged
• Multiple Myeloma (therapy)
• Peripheral Blood Stem Cell Transplantation
• Polyethylene Glycols
• Recombinant Proteins (administration & dosage)