Late Afternoon Dosing of Plerixafor for Stem Cell Mobilization: A Practical Solution

Cooper, Dennis; Pratt, Kathryn; Baker, Julie; Medoff, Erin; Conkling-Walsh, Ann; Foss, Francine M.; El, Snyder; Yen, Wu; Seropian, Stuart

doi:10.1016/j.clml.2011.03.014

Cited by 22 publications

(27 citation statements)

References 13 publications

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“…As previously reported, preplerixafor PB [CD34+] correlated well with (peak) postplerixafor [CD34+] (r = 0.78) as well as CD34+ product count (r = 0.76). Also as previously reported, prior treatment with lenalidomide did not exclude a successful collection, with all four such patients collecting more than 5 × 10 6 CD34 cells/kg.…”

Section: Discussionsupporting

confidence: 84%

“…The 17‐ to 18‐hour post‐ to preplerixafor ratio was lower than the peak post‐ to preplerixafor ratio, but this decrease did not reach clinical significance. In addition, the median of the 17‐ to 18‐hour post–pre [CD34+] ratio, 4.0, was the same as the 15‐hour post–pre [CD34+] ratio found in an earlier retrospective study and is comparable to the median 4.6 post–pre [CD34+] ratio seen at 17 hours in the earlier MM study …”

Section: Discussionsupporting

confidence: 81%

“…Pharmacodynamic studies in normal volunteers given plerixafor alone, and MM and NHL patients given G‐CSF and plerixafor, generally show increasing PB [CD34+] out to 10 to 11 hours after plerixafor. A retrospective study of 48 primarily MM and NHL patients, collected 15 hours after 5 p.m. plerixafor, found that 47 patients reached at least 2 × 10 6 CD34+ cells/kg with a median 2 days of apheresis . Recently, 22 of 31 MM patients prospectively collected approximately 17 hours after plerixafor reached at least 10 × 10 6 CD34+ cells/kg with one large‐volume leukapheresis procedure …”

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confidence: 99%

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Prospective study of mobilization kinetics up to 18 hours after late‐afternoon dosing of plerixafor

2013

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Background The current FDA-approved time interval between plerixafor dosing and apheresis initiation is ~ 11 hours, but this time interval is impractical for most care providers. Few studies have examined mobilization kinetics beyond 11 hours in multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL) patients. Therefore this study’s intent was to analyze an interval of 17–18 hours between plerixafor dosing and apheresis initiation. Study Design and Methods In 11 patients with MM or NHL, plerixafor 240 ug/kg was administered at 5pm on day 4 of G-CSF mobilization. Peripheral blood (PB) CD34+ and CD34+CD38− concentrations were enumerated every 2 hours until 7 AM and immediately pre-apheresis on day 5, for a total interval time of 17–18 hours post-plerixafor. Data was analyzed useing mixed model analysis of repeated measures and paired t-testing. Results Ten of the 11 subjects achieved a CD34+ product count of >2 × 106/kg with a single leukapheresis. All 10 had a pre-plerixafor PB CD34+ concentration of at least 10/uL. PB CD34+ concentrations were not different between 10–18 hours post-plerixafor (p≈0.8). In contrast, PB CD34+CD38− concentrations significantly increased from 10 to 18 hours post-plerixafor (p=0.03). Conclusions In MM and NHL patients with adequate pre-plerixafor CD34+ concentrations, leukapheresis initiated 14–18 hours after plerixafor/G-CSF mobilization may not impair adequate CD34+ collection and may increase more primitive CD34+CD38− collection. In this subset of patients, late afternoon dosing of plerixafor at 5 pm with initiation of next-day apheresis as late as 11 am appears feasible without loss of efficacy.

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Section: Discussionsupporting

confidence: 84%

Section: Discussionsupporting

confidence: 81%

mentioning

confidence: 99%

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Prospective study of mobilization kinetics up to 18 hours after late‐afternoon dosing of plerixafor

2013

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“…35 Other groups have reported similar findings. [36][37][38] However, such a strategy requires the presence of a accredited laboratory that can perform timely CD34+ counts to facilitate decision making. Further, as there are only retrospective reports of preemptive plerixafor, and little to guide the timing of its use, there may be centre-to-centre differences with respect to the optimal peripheral blood CD34 'cutoff' before plerixafor is administered.…”

Section: Discussionmentioning

confidence: 99%

A plerixafor-based strategy allows adequate hematopoietic stem cell collection in poor mobilizers: results from the Canadian Special Access Program

Sheppard

Bredeson

Huebsch

et al. 2014

Bone Marrow Transplant

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Plerixafor effectively mobilizes hematopoietic stem cells (HSCs). However, most patients' cells are successfully collected using traditional strategies and there is limited cost-effectiveness data. The objectives of this study were to: (1) summarize the published reports of mobilization using a plerixafor-based strategy during compassionate access programs and (2) describe the Canadian experience with plerixafor during its availability by Health Canada's Special Access Program. A literature search identified reports of plerixafor-based mobilization during compassionate access programs. Overall, successful collection of at least 2 × 10 6 CD34+ cells/ kg was achieved in~75% of patients, and about two-thirds of patients went on to HSCT. A greater proportion of patients had successful collections when plerixafor was used in the upfront or preemptive settings. Plerixafor was made available by Health Canada's SAP from September 2008 to December 2010. In 96 of 132 (73%) patients, there was successful collection of at least 2 × 10 6 CD34+ cells/kg. Ninety-nine (75%) patients went on to receive an autologous transplant. Plerixafor-based mobilization is effective in perceived poor mobilizers. The optimal way to incorporate plerixafor into a mobilization strategy, however, remains to be determined. Centre-specific analysis of resource utilization may help to identify the most cost-effective way to implement various plerixafor-based mobilization strategies.

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“…18, 20–25 However, the current schedule for plerixafor administration late in the evening prior to collection and the relatively narrow window for collecting the stem cells introduce logistical difficulties. 26 While the majority of the studies have used plerixafor by the subcutaneous route, and the current label indicates SQ route, intravenous administration has been studied in a limited fashion. Following SQ administration, plerixafor is absorbed rapidly with 70–80% bioavailability in healthy volunteer studies.…”

Section: Introductionmentioning

confidence: 99%

Phase 2 trial of intravenously administered plerixafor for stem cell mobilization in patients with multiple myeloma following lenalidomide-based initial therapy

Kumar

Mikhael

LaPlant

et al. 2013

Bone Marrow Transplant

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Initial therapy of multiple myeloma with lenalidomide-based regimens can compromise stem cell collection, which can be overcome with the addition of plerixafor. Plerixafor is typically given subcutaneously (SQ), with collection approximately 11 hours later for maximum yield. Intravenous (IV) administration may allow more rapid and predictable mobilization. This trial was designed to assess the efficacy and feasibility of IV plerixafor in patients receiving initial therapy with a lenalidomide-based regimen. Patients received G-CSF at 10 μg/kg/day for 4 days followed by IV plerixafor at 0.24 mg/kg/dose starting on day 5; plerixafor administered early in the morning with apheresis 4–5 hours later. Thirty-eight (97%) patients collected at least 3×106 CD34+ cells/kg within 2 days of apheresis. The median CD34+ cells/kg after 1 day of collection was 3.9×106 (range; 0.7–9.2) and after two days of collection was 6.99×106 (range: 1.1–16.5). There were no grade 3 or 4 non-hematological adverse events and one patient experienced grade 4 thrombocytopenia. The most common adverse events were nausea, diarrhea and abdominal bloating. IV plerixafor is an effective strategy for mobilization with low failure rate and is well tolerated. It offers flexibility with a schedule of early morning infusion followed by apheresis later in the day.

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Late Afternoon Dosing of Plerixafor for Stem Cell Mobilization: A Practical Solution

Cited by 22 publications

References 13 publications

Prospective study of mobilization kinetics up to 18 hours after late‐afternoon dosing of plerixafor

Prospective study of mobilization kinetics up to 18 hours after late‐afternoon dosing of plerixafor

A plerixafor-based strategy allows adequate hematopoietic stem cell collection in poor mobilizers: results from the Canadian Special Access Program

Phase 2 trial of intravenously administered plerixafor for stem cell mobilization in patients with multiple myeloma following lenalidomide-based initial therapy

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