Clinical Pathways and Standard Operating Procedures: Essential Tools for Outpatient Stem Cell Transplant Programs Treating Patients with AL Amyloidosis

Clinical pathways (CPs) and standard operating procedures (SOPs) are necessary for treating AL patients with high-dose melphalan and stem cell transplantation (HDM/SCT) in the outpatient setting. AL is a plasma cell dyscrasia in which abnormal proteins misfold, form fibrils and deposit in vital organs causing malfunction and death. HDM/SCT can produce hematologic remissions and prolong survival. HDM/SCT was developed for the treatment of AL at Boston University Medical Center in 1994. In 1996, treatment was moved to the outpatient setting. The program has been FACT-accredited since 2000. To date, we have performed 496 SCTs. 95% of patients are offered outpatient treatment. While patients with severe cardiac involvement are not candidates for HDM/SCT, patients with less severe cardiac disease can undergo HDM/SCT, with inpatient cardiac monitoring. The CP begins with an extensive multidisciplinary team evaluation involving members from hematology, nephrology, cardiology, pulmonology, neurology, psychiatry, nursing, nutrition, clinical research and the amyloid program. The evaluation involves 3 days of visits which assess organ involvement, performance status, support network including their ability to physically and emotionally adhere to an outpatient treatment program as well as to post-transplant follow-up, and candidacy for a research protocol. Weekly meetings are held to discuss evaluation results and determine eligibility before a patient can be scheduled. Once treatment begins, daily rounds, including toxicity evaluations, physical exams, medication review and reinforcement of the treatment plan are conducted. Oral and written instructions are provided regarding expected toxicities, symptom management and emergency contacts. Prophylactic treatment with antiemetic, antibacterial, antiviral, antifungal and growth factors are used. The most common reason for hospital admission is febrile neutropenia. Severe nausea, vomiting, diarrhea, dehydration may also necessitate hospitalization. CPs and SOPs were developed early on in the program and are adhered to with a mechanism to document any deviations. CPs are reviewed annually for revisions based on current peer-reviewed literature and program experience. Educational short courses are held regularly for staff to insure adherence to CPs and SOPs. In summary, outpatient HDM/SCT is a feasible treatment option for patients with AL amyloidosis, provided treatment is conducted in an experienced center. Clinical pathways (CPs) and standard operating procedures (SOPs) are necessary for treating AL patients with high-dose melphalan and stem cell transplantation (HDM/SCT) in the outpatient setting. AL is a plasma cell dyscrasia in which abnormal proteins misfold, form fibrils and deposit in vital organs causing malfunction and death. HDM/SCT can produce hematologic remissions and prolong survival. HDM/SCT was developed for the treatment of AL at Boston University Medical Center in 1994. In 1996, treatment was moved to the outpatient setting. The program has been FACT-accredited since 2000. To date, we have performed 496 SCTs. 95% of patients are offered outpatient treatment. While patients with severe cardiac involvement are not candidates for HDM/SCT, patients with less severe cardiac disease can undergo HDM/SCT, with inpatient cardiac monitoring. The CP begins with an extensive multidisciplinary team evaluation involving members from hematology, nephrology, cardiology, pulmonology, neurology, psychiatry, nursing, nutrition, clinical research and the amyloid program. The evaluation involves 3 days of visits which assess organ involvement, performance status, support network including their ability to physically and emotionally adhere to an outpatient treatment program as well as to post-transplant follow-up, and candidacy for a research protocol. Weekly meetings are held to discuss evaluation results and determine eligibility before a patient can be scheduled. Once treatment begins, daily rounds, including toxicity evaluations, physical exams, medication review and reinforcement of the treatment plan are conducted. Oral and written instructions are provided regarding expected toxicities, symptom management and emergency contacts. Prophylactic treatment with antiemetic, antibacterial, antiviral, antifungal and growth factors are used. The most common reason for hospital admission is febrile neutropenia. Severe nausea, vomiting, diarrhea, dehydration may also necessitate hospitalization. CPs and SOPs were developed early on in the program and are adhered to with a mechanism to document any deviations. CPs are reviewed annually for revisions based on current peer-reviewed literature and program experience. Educational short courses are held regularly for staff to insure adherence to CPs and SOPs. In summary, outpatient HDM/SCT is a feasible treatment option for patients with AL amyloidosis, provided treatment is conducted in an experienced center.