Original Article

Bone Marrow Transplantation (2008) 41, 331–338; doi:10.1038/sj.bmt.1705908; published online 12 November 2007

Stem Cell Collection

AMD3100 plus G-CSF can successfully mobilize CD34+ cells from non-Hodgkin's lymphoma, Hodgkin's disease and multiple myeloma patients previously failing mobilization with chemotherapy and/or cytokine treatment: compassionate use data

G Calandra1, J McCarty2, J McGuirk3, G Tricot4, S-A Crocker1, K Badel1, B Grove1, A Dye1 and G Bridger1

  1. 1AnorMED Corp of Genzyme Corp, Langley, British Columbia, Canada
  2. 2Department of Internal Medicine, Hematology/Oncology, Virginia Commonwealth University, Richmond, VA, USA
  3. 3Blood and Bone Marrow Transplant Clinic, Kansas City Cancer Center, Kansas City, MO, USA
  4. 4Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock, AR, USA

Correspondence: Dr G Calandra, Clinical Development, AnorMED (Genzyme) Corporation, 200-20353, 64th Avenue, Langley, British Columbia, Canada V3Y 1N5. E-mail: gcalandra@anormed.com

Received 24 August 2007; Revised 21 September 2007; Accepted 25 September 2007; Published online 12 November 2007.

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Abstract

AMD3100 given with G-CSF has been shown to mobilize CD34+ cells in non-Hodgkin's lymphoma (NHL), multiple myeloma (MM), and Hodgkin's disease (HD) patients who could not collect sufficient cells for autologous transplant following other mobilization regimens. These poor mobilizers are usually excluded from company-sponsored trials, but have been included in an AMD3100 Single Patient Use protocol, referred to as a Compassionate Use Protocol (CUP). A cohort of 115 data-audited poor mobilizers in CUP was assessed, with the objective being to collect greater than or equal to2 × 106 CD34+ cells per kg following AMD3100 plus G-CSF mobilization. The rates of successful CD34+ cell collection were similar for patients who previously failed chemotherapy mobilization or cytokine-only mobilization: NHL—60.3%, MM—71.4% and HD—76.5%. Following transplant, median times to neutrophil and PLT engraftment were 11 days and 18 days, respectively. Engraftment was durable. There were no drug-related serious adverse events. Of the adverse events considered related to AMD3100, two (1.6%) were severe (one patient—headache, one patient—nightmares). Other AMD3100-related adverse events were mild (84.8%) or moderate (13.6%). The most common AMD3100-related adverse events were gastrointestinal reactions, injection site reactions and paresthesias. AMD3100 plus G-CSF offers a new treatment to collect CD34+ cells for autologous transplant from poor mobilizers, with a high success rate.

Keywords:

stem cells, autologous transplant, PBSC