title: Plerixafor and G-CSF for autologous stem cell mobilization in patients with NHL, Hodgkin's lymphoma and multiple myeloma: results from the expanded access program.
abstract: Before US regulatory approval, an expanded access program provided plerixafor to patients with non-Hodgkin's lymphoma (NHL), Hodgkin's lymphoma (HD) or multiple myeloma (MM) who had not previously failed mobilization and were otherwise candidates for auto-SCT. Patients received granulocyte-CSF (G-CSF) 10 mcg/kg daily and plerixafor 0.24 mg/kg starting on day 4 with apheresis on day 5; all repeated daily until collection was complete. Overall, 104 patients received 1 dose of plerixafor. The addition of plerixafor to G-CSF resulted in a median threefold increase in peripheral blood CD34+ cell count between days 4 and 5. Among 43 NHL patients, 74% met the target of 5 × 10(6) CD34+ cells/kg (median, 1 day apheresis, range 1-5 days); among 7 HD patients, 57% met the target of 5 × 10(6) CD34+ cells/kg (median, 2 days apheresis, range 1-3); and among 54 MM patients, 89% met the target of 6 × 10(6) CD34+ cells/kg (median, 1 day apheresis, range 1-4). Overall, 93% of patients had 2 × 10(6) CD34+ cells/kg collected within 1-3 days. Plerixafor-related toxicities were minimal. Engraftment kinetics, graft durability and transplant outcomes demonstrated no unexpected outcomes. Efficacy and safety results were similar to results in phase II and III clinical trials.
authors.affiliation: Adult Bone Marrow Transplant, Texas Transplant Institute, San Antonio, TX 78229, USA. paul.shaughnessy@mhshealth.com
authors.forename: P
authors.initials: P
authors.lastname: Shaughnessy
authors.forename: J
authors.initials: J
authors.lastname: Uberti
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authors.initials: S
authors.lastname: Devine
authors.forename: R T
authors.initials: RT
authors.lastname: Maziarz
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authors.lastname: Vose
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authors.lastname: Micallef
authors.forename: E
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authors.lastname: Jacobsen
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authors.lastname: McCarty
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authors.lastname: Stiff
authors.forename: A
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authors.lastname: Artz
authors.forename: E D
authors.initials: ED
authors.lastname: Ball
authors.forename: R
authors.initials: R
authors.lastname: Berryman
authors.forename: M
authors.initials: M
authors.lastname: Dugan
authors.forename: R
authors.initials: R
authors.lastname: Joyce
authors.forename: F J
authors.initials: FJ
authors.lastname: Hsu
authors.forename: D
authors.initials: D
authors.lastname: Johns
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authors.lastname: McSweeney
mesh_terms: D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001596:Benzylamines; D001781:Blood Component Removal; D000080027:Cyclams; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects; D019650:Hematopoietic Stem Cell Mobilization; D006412:Hematopoietic Stem Cells; D006571:Heterocyclic Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D006689:Hodgkin Disease / Q000097:blood / Q000628:therapy*; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000097:blood / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000097:blood / Q000628:therapy*; D036102:Peripheral Blood Stem Cell Transplantation; D012189:Retrospective Studies; D013997:Time Factors; D014182:Transplantation, Autologous; D014481:United States
chemical_list: D019380:Anti-HIV Agents; D001596:Benzylamines; D000080027:Cyclams; D006571:Heterocyclic Compounds; D016179:Granulocyte Colony-Stimulating Factor; C088327:plerixafor