title: 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.affiliation: Department of Haematology, Peter MacCallum Cancer Centre, St Andrew's Place, East Melbourne, Victoria, Australia.
authors.forename: K E
authors.initials: KE
authors.lastname: Herbert
authors.affiliation: Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia.
authors.forename: L
authors.initials: L
authors.lastname: Demosthenous
authors.affiliation: Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia.
authors.forename: G
authors.initials: G
authors.lastname: Wiesner
authors.affiliation: Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia.
authors.forename: E
authors.initials: E
authors.lastname: Link
authors.affiliation: Department of Pathology, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia.
authors.forename: D A
authors.initials: DA
authors.lastname: Westerman
authors.affiliation: Department of Pathology, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia.
authors.forename: N
authors.initials: N
authors.lastname: Came
authors.affiliation: 1] Department of Haematology, Peter MacCallum Cancer Centre, St Andrew's Place, East Melbourne, Victoria, Australia [2] Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: D S
authors.initials: DS
authors.lastname: Ritchie
authors.affiliation: 1] Department of Haematology, Peter MacCallum Cancer Centre, St Andrew's Place, East Melbourne, Victoria, Australia [2] Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: S
authors.initials: S
authors.lastname: Harrison
authors.affiliation: 1] Department of Haematology, Peter MacCallum Cancer Centre, St Andrew's Place, East Melbourne, Victoria, Australia [2] Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: J F
authors.initials: JF
authors.lastname: Seymour
authors.affiliation: 1] Department of Haematology, Peter MacCallum Cancer Centre, St Andrew's Place, East Melbourne, Victoria, Australia [2] Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: H M
authors.initials: HM
authors.lastname: Prince
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D064592:Autografts; D001596:Benzylamines; D001781:Blood Component Removal / Q000379:methods; D000080027:Cyclams; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods*; D006571:Heterocyclic Compounds / Q000008:administration & dosage*; D006801:Humans; D008223:Lymphoma / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000628:therapy*; D036102:Peripheral Blood Stem Cell Transplantation; D011092:Polyethylene Glycols; D011994:Recombinant Proteins / Q000008:administration & dosage
chemical_list: D019380:Anti-HIV Agents; D001596:Benzylamines; D000080027:Cyclams; D006571:Heterocyclic Compounds; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069585:Filgrastim; C088327:plerixafor