High-dose melphalan at 200 mg/m 2 can be administered in 1 day or over 2 consecutive days before autologous hematopoietic cell transplantation (HCT) for multiple myeloma (MM). Limited data exist on the comparison of the two dosing schedules. A retrospective study of 278 consecutive MM patients receiving high-dose melphalan from January 2010 to December 2012 was conducted. Objectives were to compare the length of hospitalization, toxicity profile, response rates, PFS and OS. One hundred and eighty five patients received 2-day dosing and 93 received 1-day dosing. The two end points of the 95% confidence interval (CI) for the difference did not exceed the preselected margin, therefore the length of hospitalization was considered equivalent. No significant differences were found for response rates, PFS and OS. The toxicity profile was similar with the exception of more frequent ⩾ grade 3 oral mucositis in the 2-day group (13.5% vs 5.4%; odds ratio 3.07 (95% CI:1.11-8.48); P = 0.03). High-dose melphalan, given either in 1 day or over 2 days, produced comparable treatment outcomes except for increased grade 3/4 mucositis in the 2-day regimen. One-day dosing could shorten the hospital stay by 1 day and may allow better resource utilization. INTRODUCTIONMultiple myeloma (MM) is an incurable clonal B-cell neoplasm characterized by proliferation of malignant plasma cells in the BM, presence of monoclonal protein in the blood and/or urine and associated organ dysfunction. 1,2 MM comprises of~10% of all hematologic malignancies. OS of MM patients have steadily increased over the past few decades in part owing to the implementation of high-dose chemotherapy followed by autologous hematopoietic cell transplantation (HCT), availability of novel agents and improved supportive care. 3,4 Recent incorporation of lenalidomide to post-transplant maintenance therapy improved PFS, setting the stage for further incremental survival improvement. 5,6 Although high-dose melphalan 200 mg/m 2 is established as the standard conditioning regimen for autologous HCT, the practice variations exist on the dosing schedule. 7-9 High-dose melphalan can be administered over 1 day or given over 2 consecutive days (100 mg/m 2 /day). Adverse events deriving from high-dose melphalan occur in a dose-dependent fashion. Grazziutti et al. 10 found higher milligram per kilogram melphalan doses and renal dysfunction (both reflecting increased melphalan exposure) being the key pre-transplant factors for severe oral mucositis following autologous HCT in myeloma patients. Palumbo et al. 11 demonstrated a greater incidence of gastrointestinal side effects in patients with MM who received high-dose melphalan at 200 mg/m 2 vs patients who received melphalan 100 mg/m 2 as conditioning for tandem autologous HCT, where all doses of melphalan were given over 1 day. However, neither of the aforementioned studies compared toxicity profiles between

Background Current workforce shortages within the hematopoietic stem cell transplant field necessitate capitalizing on the role of oncology-trained pharmacists. Working within an agreed-upon protocol, pharmacists are able to expand patient care delivery through optimal medication therapy management. Methods An electronic survey was developed by the Advocacy & Policy Working Committee of the American Society for Blood and Marrow Transplantation Pharmacy Special Interest Group and distributed to pharmacists involved in the care of hematopoietic stem cell transplant patients. The primary objective was to assess the current state of collaborative practice agreements in the hematopoietic stem cell transplant setting. Results Forty-eight responses representing 41 institutions were returned. Respondents were mostly female (67%) and practiced in the adult setting (83%). Reponses represented a range of practice experience in hematopoietic stem cell transplant with the majority of the hematopoietic stem cell transplant positions (83%) funded by the department of pharmacy at an academic medical center. Of the 48 responses, 22 (46%) respondents reported having collaborative practice agreements in place; 10 (21%) respondents did not currently have collaborative practice agreements, but were planning to implement them; and 16 (33%) respondents did not have collaborative practice agreements at their institution. Clinical activities performed under a collaborative practice agreement included medication selection and dosing modifications, therapeutic drug monitoring, supportive care management, and management of comorbid conditions and chronic diseases. The most commonly cited barrier to establishing collaborative practice agreements was the inability to secure reimbursement for services provided. No respondents reported a negative impact on job satisfaction. Conclusions The results of this survey provide the pharmacy community with a robust understanding of the current landscape of hematopoietic stem cell transplant pharmacy collaborative practice agreements.

4060 Study Purpose and Methods: Following FDA approval of plerixafor, our institution developed practice guidelines using a risk-based algorithm to optimize the use of plerixafor for CD34 cell mobilization in autologous hematopoietic cell transplant (HCT) candidates. We defined patients (pts) at high risk for mobilization failure and eligible to receive G-CSF 10 mcg/kg/day for 4 days with plerixafor 0.24 mg/kg added on day 4 if they met any of the following criteria: 1) 3 or more lines of prior chemotherapy; 2) 2 or more lines of prior chemotherapy plus a radioimmunoconjugate or extensive field radiation therapy (XRT); 3) 4 or more cycles of hyper-CVAD, 4) 4 or more cycles of lenalidomide; or 5) hypocellular bone marrow (<25% cellularity) prior to mobilization. Apheresis began on day 5 of mobilization for all pts. Pts not meeting this criteria received G-CSF alone unless the first day apheresis yield was less than 0.5 million CD34 cells/kg or peripheral CD34 count was <10/μmL in which case plerixafor was added. In order to evaluate the efficacy of plerixafor in these high risk patients and validate the risk categories, we conducted a retrospective review of consecutive pts mobilized before and after guideline institution. The primary endpoint was the proportion of pts collecting 2 million CD34 cells/kg in one apheresis. Results: 415 pts were mobilized between 1/1/2008–8/31/10, 334 received G-CSF and 81 received G-CSF and plerixafor. G-CSF pts received 10 or 20 mcg/kg/day for 4 days, depending on institutional practice. This analysis includes those determined to be high risk by the above listed categories: 124 G-CSF pts and 72 plerixafor pts. The most common high risk categories represented were 3 or more lines of prior chemotherapy (group 1): 61 G-CSF pts and 27 plerixafor pts; 4 or more cycles of hyperCVAD (group 2): 14 G-CSF pts and 15 plerixafor pts; and 4 or more cycles of lenalidomide (group 3): 31 G-CSF pts and 27 plerixafor pts. For group 1 patients 38% of G-CSF pts collected >2 million in one apheresis compared to 67% of plerixafor pts (p=0.014). For group 2 pts, the respective proportions were 21% vs 47% (p=0.153) and for group 3 pts, the respective proportions were 39% vs 100% (p<0.001). Conclusions: Our results validate the risk categories used in our guidelines since less than 50% of high risk G-CSF patients analyzed were able to mobilize a sufficient number of CD34 cells with one apheresis. In addition, plerixafor was associated with a larger proportion of pts who collected 2 million CD34 cells/kg in one apheresis, suggesting superior efficacy in these high risk patients. We conclude that there are specific pts that should receive plerixafor in order to reduce the number of aphereses necessary to proceed to HCT. This may be a more reliable and efficient practice than assessing peripheral CD34 counts prior to apheresis as these counts may not always accurately predict CD34 yield or be available in a timely manner. Disclosures: Shapiro: Genzyme: Research Funding, Speakers Bureau. Perkins:Genzyme: Research Funding. Bookout:Genzyme: Research Funding. Fernandez:Genzyme: Membership on an entity's Board of Directors or advisory committees, Research Funding.

Primary central nervous system lymphoma (PCNSL) is a rare B-cell lymphoid neoplasm for which current regimens utilizing standard-dose chemotherapy and/or radiation therapy lead to high relapse rates and/or unacceptable neurologic sequelae. High-dose chemotherapy followed by hematopoietic stem cell transplantation may overcome limitations of current treatment schemas. A search was performed of all English-language literature (1968 to June 2009) within the MEDLINE, EMBASE and Cochrane Library databases to identify relevant clinical trials using the terms stem cell transplantation, bone marrow transplantation, primary central nervous system lymphoma, and PCNSL. Bibliographies were reviewed to extract other relevant articles. Use of high-dose chemotherapy followed by hematopoietic stem cell transplantation for the treatment of PCNSL in a predominantly elderly population is feasible. Use of this treatment modality for newly diagnosed and recurrent or relapsed disease is burdened by a paucity of data guiding patient selection, optimal induction regimen, stem cell mobilization and conditioning chemotherapy. Data are also sparse and confounding regarding timing of initiation of this procedure relative to the natural history of the disease and timing of each chemotherapy regimen relative to each other. High-dose chemotherapy followed by hematopoietic stem cell transplantation remains an experimental procedure with insufficient data to guide clinicians. However, the data are encouraging and merit continued research to guide patient selection and treatment regimens which may produce optimal outcomes.

No abstract