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

P. Shaughnessy, J. Uberti, S. Devine, R. T. Maziarz, Julie Marie Vose, I. Micallef, E. Jacobsen, J. McCarty, P. Stiff, A. Artz, E. D. Ball, R. Berryman, M. Dugan, R. Joyce, F. J. Hsu, D. Johns, P. McSweeney

Research output: Contribution to journalArticle

25 Citations (Scopus)

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 × 106 CD34+ cells/kg (median, 2 days apheresis, range 1-3); and among 54 MM patients, 89% met the target of ≥6 × 106 CD34+ cells/kg (median, 1 day apheresis, range 1-4). Overall, 93% of patients had ≥2 × 106 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.

Original languageEnglish (US)
Pages (from-to)777-781
Number of pages5
JournalBone marrow transplantation
Volume48
Issue number6
DOIs
StatePublished - Jun 1 2013

Fingerprint

Hematopoietic Stem Cell Mobilization
Multiple Myeloma
Hodgkin Disease
Granulocytes
Non-Hodgkin's Lymphoma
Blood Component Removal
Transplants
Phase III Clinical Trials
Phase II Clinical Trials
Blood Cell Count
JM 3100
Safety

Keywords

  • autologous transplant
  • mobilization
  • plerixafor

ASJC Scopus subject areas

  • Hematology
  • Transplantation

Cite this

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. / Shaughnessy, P.; Uberti, J.; Devine, S.; Maziarz, R. T.; Vose, Julie Marie; Micallef, I.; Jacobsen, E.; McCarty, J.; Stiff, P.; Artz, A.; Ball, E. D.; Berryman, R.; Dugan, M.; Joyce, R.; Hsu, F. J.; Johns, D.; McSweeney, P.

In: Bone marrow transplantation, Vol. 48, No. 6, 01.06.2013, p. 777-781.

Research output: Contribution to journalArticle

Shaughnessy, P, Uberti, J, Devine, S, Maziarz, RT, Vose, JM, Micallef, I, Jacobsen, E, McCarty, J, Stiff, P, Artz, A, Ball, ED, Berryman, R, Dugan, M, Joyce, R, Hsu, FJ, Johns, D & McSweeney, P 2013, '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', Bone marrow transplantation, vol. 48, no. 6, pp. 777-781. https://doi.org/10.1038/bmt.2012.219
Shaughnessy, P. ; Uberti, J. ; Devine, S. ; Maziarz, R. T. ; Vose, Julie Marie ; Micallef, I. ; Jacobsen, E. ; McCarty, J. ; Stiff, P. ; Artz, A. ; Ball, E. D. ; Berryman, R. ; Dugan, M. ; Joyce, R. ; Hsu, F. J. ; Johns, D. ; McSweeney, P. / 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. In: Bone marrow transplantation. 2013 ; Vol. 48, No. 6. pp. 777-781.
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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 × 106 CD34+ cells/kg (median, 2 days apheresis, range 1-3); and among 54 MM patients, 89{\%} met the target of ≥6 × 106 CD34+ cells/kg (median, 1 day apheresis, range 1-4). Overall, 93{\%} of patients had ≥2 × 106 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.",
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