Washington university nursing experience coordinating patient care on a phase III trial evaluating AMD3100 (MOZOBIL™), a novel drug for stem cell mobilization

Abstract

AMD3100 (MOZOBIL™) is a novel agent which induces a rapid increase in the number of stem cells in peripheral blood. It appears to be safe and when combined with G-CSF may increase the yield of stem cells compared to G-CSF alone. The optimum mobilization occurs when the drug is scheduled the evening prior to apheresis, creating a number of potential logistical difficulties managing trials evaluating this agent. As we commenced accrual to a phase III placebo controlled study comparing G-CSF alone to its combination with MOZOBIL, we worked diligently to ensure there were no gaps in patient care. Patient teaching strategies included verbal instruction contrasting historical methods of stem cell mobilization with this novel procedure as well as printed BMT literature. All patients and their caregivers were offered involvement in a patient education class. The RN coordinator was instrumental in creating the patient’s mobilization schema and further collaborating with the clinical research associate, apheresis department, stem cell laboratory, and the inpatient and outpatient treatment areas. Since our medical center does not have an after hours outpatient clinic, our patients received MOZOBIL/placebo on a designated inpatient unit. Challenges with this approach occurred when the inpatient unit was understaffed or had high acuity patients. Additionally, the inpatient RNs expressed concern regarding their unfamiliarity with this new method of stem cell mobilization. The patients appreciated the inpatient RN’s assistance in this protocol but were initially dissatisfied with the lack of privacy on a busy inpatient unit. A private area on the inpatient unit was later secured for study patients to be assessed and monitored. The administration schedule created some frustration on the part of the patients due to the long delay between study drug injection and apheresis. Nevertheless, accrual to this trial at our institution has been relatively brisk. Patient education, nursing coordination, and collaboration with members of the BMT team were paramount in our successful implementation of this study. Designated nursing staff committed to clinical trials, as well as detailed, mandatory inservices need to occur in order to implement a complex BMT trial such as this. Our experience with this trial leads us to conclude that in order to determine whether patients may benefit from novel BMT strategies, effective nursing teamwork, education, and collaboration will be essential. AMD3100 (MOZOBIL™) is a novel agent which induces a rapid increase in the number of stem cells in peripheral blood. It appears to be safe and when combined with G-CSF may increase the yield of stem cells compared to G-CSF alone. The optimum mobilization occurs when the drug is scheduled the evening prior to apheresis, creating a number of potential logistical difficulties managing trials evaluating this agent. As we commenced accrual to a phase III placebo controlled study comparing G-CSF alone to its combination with MOZOBIL, we worked diligently to ensure there were no gaps in patient care. Patient teaching strategies included verbal instruction contrasting historical methods of stem cell mobilization with this novel procedure as well as printed BMT literature. All patients and their caregivers were offered involvement in a patient education class. The RN coordinator was instrumental in creating the patient’s mobilization schema and further collaborating with the clinical research associate, apheresis department, stem cell laboratory, and the inpatient and outpatient treatment areas. Since our medical center does not have an after hours outpatient clinic, our patients received MOZOBIL/placebo on a designated inpatient unit. Challenges with this approach occurred when the inpatient unit was understaffed or had high acuity patients. Additionally, the inpatient RNs expressed concern regarding their unfamiliarity with this new method of stem cell mobilization. The patients appreciated the inpatient RN’s assistance in this protocol but were initially dissatisfied with the lack of privacy on a busy inpatient unit. A private area on the inpatient unit was later secured for study patients to be assessed and monitored. The administration schedule created some frustration on the part of the patients due to the long delay between study drug injection and apheresis. Nevertheless, accrual to this trial at our institution has been relatively brisk. Patient education, nursing coordination, and collaboration with members of the BMT team were paramount in our successful implementation of this study. Designated nursing staff committed to clinical trials, as well as detailed, mandatory inservices need to occur in order to implement a complex BMT trial such as this. Our experience with this trial leads us to conclude that in order to determine whether patients may benefit from novel BMT strategies, effective nursing teamwork, education, and collaboration will be essential.