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Stem Cell Procurement

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 volume 48, pages 777–781 (2013)Cite this article

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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 × 106 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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Acknowledgements

We thank Monica Nicosia, PhD, and Angela Partisano, PharmD, MS (Sanofi) for editorial assistance in preparing this manuscript.

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Authors and Affiliations

  1. Adult Bone Marrow Transplant, Texas Transplant Institute, San Antonio, TX, USA

    P Shaughnessy

  2. Karmanos Cancer Institute, Detroit, MI, USA

    J Uberti

  3. Department of Internal Medicine/Hematology/Oncology, Ohio State University, Columbus, OH, USA

    S Devine

  4. Adult Bone Marrow Transplant, Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA

    R T Maziarz

  5. Adult Bone Marrow Transplant, University of Nebraska Medical Center, Omaha, NE, USA

    J Vose

  6. Mayo Clinic, Rochester, MN, USA

    I Micallef

  7. Dana Farber Cancer Institute, Boston, MA, USA

    E Jacobsen

  8. Adult Bone Marrow Transplant, Virginia Commonwealth University, Richmond, VA, USA

    J McCarty

  9. Loyola University Medical Center, Maywood, IL, USA

    P Stiff

  10. Adult Bone Marrow Transplant, University of Chicago, Chicago, IL, USA

    A Artz

  11. Adult Bone Marrow Transplant, University of California San Diego, La Jolla, CA, USA

    E D Ball

  12. Baylor Blood and Marrow Transplant Center, Dallas, TX, USA

    R Berryman

  13. Indiana Blood and Marrow Transplantation, Beech Grove, IN, USA

    M Dugan

  14. Beth Israel Deaconess Medical Center, Boston, MA, USA

    R Joyce

  15. Sanofi Oncology, Cambridge, MA, USA

    F J Hsu & D Johns

  16. Rocky Mountain Cancer Center, Denver, CO, USA

    P McSweeney

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  1. P Shaughnessy
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Correspondence to P Shaughnessy.

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Competing interests

This study was sponsored by Sanofi Oncology (previously Genzyme Corporation). PS, RTM, JMC, SD, MD and PMS received honoraria and research funding from Genzyme. IM, JV and PS received research funding from Sanofi/Genzyme. FJH is a former Genzyme employee and is now an employee of Zyngenia, Inc. DJ is an employee of Sanofi Oncology (formerly Genzyme). All the other author declare no conflicts of interest.

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Shaughnessy, P., Uberti, J., Devine, S. et al. 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 Transplant 48, 777–781 (2013). https://doi.org/10.1038/bmt.2012.219

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