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OBJECTIVES: Findings from a brief geriatric assessment (GA) in a cohort of adults with multiple myeloma (MM) are presented, with particular attention to the utility of the GA in identifying important deficits in adults judged to have a normal Karnofsky Performance Status (KPS ≥ 80). MATERIALS AND METHODS: Adults age 18 and older with MM were recruited into an observational study from 2018 to 2020. A modified Cancer and Aging Research Group (CARG) GA was administered at enrollment. Enrollees also completed the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients Core 30 questionnaire (QLQ-C30), with subscales of physical, social, role, and cognitive functioning (range 0-100; higher values indicate better function). Data were analyzed using descriptive statistics for the full cohort and stratified by concurrent KPS (score < 80 vs ≥ 80). RESULTS: Among 89 adults, the mean age was 69.1 years, 68% were aged ≥ 65 years, and 70% were white. In this cohort, 78% had KPS ≥ 80. Among those with KPS ≥ 80, functional impairments (Timed Up and Go ≥ 14 seconds and dependence in ≥ 1 instrumental activity of daily living) were seen in 30% and 21%, respectively, with 11% reporting ≥ 1 fall in the prior 6 months. At least two GA-identified deficits were detected in 50% of the overall cohort and in 41% of those with KPS ≥ 80. Among those with KPS ≥ 80, self-reported physical impairment on EORTC QLQ-C30 was noted by 34%. CONCLUSION: Using a modified CARG GA and EORTC questionnaire, functional impairments were identified among adults considered to have a good performance status based on a KPS (≥ 80). Future studies should focus on using GA measures for therapy assignment and identifying opportunities for intervening upon GA-identified deficits.

e20004 Background: Multiple myeloma (MM) and immunoglobulin light chain (AL) amyloidosis are clonal plasma cell disorders (PCDs) of aging, with median ages at diagnosis of 69 and 76 years, respectively. The care of adults with these disorders is often challenging due to the higher prevalence of vulnerabilities with advancing age. We examined the prevalence of physical or cognitive impairments and associations with quality-of-life (QoL) ratings in a longitudinal cohort of adults with PCDs. Methods: Adults undergoing treatment for PCDs were recruited to a longitudinal observational study (NCT03717844) from 2018 to 2020. A modified Cancer and Aging Research Group (CARG) geriatric assessment (GA) was administered at enrollment. Patients also completed the European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC QLQ-C30), which provided subscales of physical function, cognitive function, and global QoL (range 0-100; higher values indicate better function or QoL). Univariate linear regression was used to evaluate associations at the time of enrollment. Results: Among 121 consecutive adults, the mean age was 69 years, 65.8% were aged ≥ 65 years, and 71.9% were white. Diagnoses included MM in 73.6%, AL amyloidosis in 14.0%, and both disorders in 7.4%. The remaining 5.0% had another PCD warranting chemotherapy. Time from diagnosis at enrollment was ≤ 6 months for 25.6%, 6 to 24 months for 18.1%, and ≥ 24 months for 56.3%. In this cohort, 80.2% had a clinician-assessed Karnofsky Performance Status (KPS) score ≥ 80. GA-identified impairments (Timed Up and Go ≥ 14 seconds and dependence in ≥ 1 instrumental activity of daily living [IADL]) were seen in 29.8% and 35.6%, respectively, with 13.5% reporting ≥ 1 fall in the prior 6 months. Polypharmacy (≥ 5 medications) was identified in 80.0%. Self-reported physical and cognitive impairments on QLQ-C30 were described by 48.7% and 20.2%, respectively. Patients with functional deficits had worse EORTC QoL scores compared to those without deficits: dependence in ≥ 1 IADL (mean QoL score 66.3 vs. 79.9, p = 0.0009), ≥ 1 fall (56.7 vs. 76.8, p = 0.0009), self-reported physical impairment on QLQ-C30 (64.0 vs. 84.5, p < 0.0001), and self-reported cognitive impairment on QLQ-C30 (61.2 vs. 77.7, p = 0.0012). Conclusions: Using a modified CARG GA and the EORTC QLQ-C30, we identified physical and cognitive impairments among adults undergoing treatment for PCDs. GA-identified impairments in physical function were more prevalent than clinician-assessed KPS would suggest. Patients with physical and cognitive impairments had worse QoL scores than those without deficits. Future research involving this cohort will investigate the longitudinal trajectory of physical and cognitive functioning, evaluate trends in QoL measurements, and test the feasibility of implementing GA-guided interventions for this population.

e18540 Background: Multiple myeloma (MM) is a disease of aging, associated with one of the greatest black-white disparities in incidence and mortality among all US cancer types. Clinical trials provide the critical evidence-base to inform clinical management in all cancers, including MM. However, clinical trial participants are often younger (age < 65 years) and white, limiting the generalizability of published data to real-world MM care. Although geographical and financial barriers to clinical trial participation are well recognized, less is known about the association of county-level social vulnerability with MM trial availability. We examined county-level variation in the number of registered myeloma trials per 10,000 North Carolina (NC) residents age ≥ 65 years as a function of social vulnerability and the presence of a National Cancer Institute Comprehensive Cancer Center (CCC). Methods: We conducted a cross-sectional study using data from ClinicalTrials.gov to identify all registered interventional myeloma trials involving adults age ≥ 65 years with sites in NC. Records were downloaded on January 24th, 2021. This strategy yielded 456 non-unique NC sites for 223 trials. We obtained county locations for all trial sites by matching city, zip code, or institution name. We obtained NC population data for residents age ≥ 65 years (in 2019) from the American Community Survey. The four themes (socioeconomic status, household composition, ethnic and racial minority status/language, housing/transportation) within the Centers for Disease Control Social Vulnerability Index (CDC SVI) (composite score: 0-1, with a higher number indicating more vulnerability) were used to characterize county-level social vulnerability. We performed negative binomial regression and tabulations using R, version 3.6.1. A p-value < 0.05 was considered statistically significant. Results: Across 100 counties in NC, trial site counts by county per 10,000 residents age ≥ 65 years ranged from 0 to 23.2 (mean: 1.5, median: 0; IQR, 0-0.7). Controlling for the 4 SVI themes, counties with CCCs (Durham, Forsyth, Orange) had 77% more trials than those without CCCs [Incidence Rate Ratio (IRR): 7.74; p = 0.05]. We observed a 3.3% reduction in trial counts with each percentile increase in socioeconomic vulnerability (IRR: 0.97; p = 0.008). Counties with higher representation by racial and ethnic minorities had similar trial site counts to counties with lower minority populations (IRR: 1.01; p = 0.08). Sub-group analyses of early-stage studies (phase 1/2 and phase 2; n = 268) and late-stage studies (phase 2/3 and phase 3; n = 168) were similar. Conclusions: Our preliminary results suggest county-level socioeconomic status is associated with the distribution of MM clinical trial sites across NC. Further work is planned to explore whether additional variances in trial distribution could be explained by site- and study-specific characteristics.

INTRODUCTION High dose chemotherapy (HDC) followed by Autologous stem cell transplant (ASCT) has been shown to provide curative benefit in patients with relapsed lymphoma and multiple myeloma, often times requiring hematopoietic support until marrow engraftment. Due to Jehovah's Witnesses (JW), refusal of blood products treatment challenges arise. This prospective study represents 125 JW with lymphoma (n= 55), multiple myeloma (MM) (n= 68) or amyloidosis (n=2), treated with HDC and ASCT without transfusions. PATIENTS AND METHODS All patients with diagnoses of MM and lymphoma were considered eligible for enrollment, irrespective of prior regimens or complete remissions. Patients were primed pre-transplant with intravenous iron and erythropoietin at a dose of 60,000 units weekly. Cytokine mobilization of stem cells was used preferentially over chemo-mobilization to facilitate apheresis. HDC post apheresis was delayed until hemoglobin (Hb) and platelets approached 11g/dl and 100 x 103/ μL respectively. All patients with multiple myeloma received standard dose Melphalan 200mg/m2, with dose adjustment to 140-150mg/m2 in patients with severe kidney dysfunction. Lymphoma patients received BCNU 300mg/m2 on day 1, Cyclophosphamide 1500mg/m2 day 2-5, and VP16 700mg/m2/day on days 2-4. Post-transplant, blood management techniques included minimization of unnecessary phlebotomy, limitation of potential sources of blood loss, namely from the gastrointestinal tract, by the utilization of proton pump inhibitors and stool softeners and avoidance of antiplatelet agents wherever possible. In menstruating females progestational agents were given to cease menstrual flow. All patients received granulocyte colony stimulating factor (G-CSF) and erythropoietin. Thrombocytopenia was managed with the antifibrinolytic agent aminocaproic acid, phythonadione and rarely cryoprecipitate. RESULTS Ninety percent of patients (n=113) were alive at 100 days post transplantation, and 12 patients had died prior to 100 days. Six patients (4.8%) died prior to day 30 and were considered transplant-related mortalities (TRMs). The etiologies were as follows: profound anemia (n=1), severe sepsis (n=1), multi-organ failure due to pancytopenia (n=1) or cardiac events (n=3). Since March 2010 there have been no additional TRMs. There were 2 life threatening (grade 3 – 4) but non-fatal bleeding complications, 2 grade 2 bleeding complications and minor bleeding (grade 1) in 15 patients. The median decrease in Hb was 5.0 g/dL (range 0-10) for all patients, with a median Hb nadir of 7.0 g/dL. The median total number of days with a platelet count < 10 x 103/μL was 3 days (range 0–14) with a median platelet nadir of 5.0 x 103/μL. Cardiac complications occurred in 40 patients (32%), most commonly arrhythmias (n=23). CONCLUSION ASCT can safely be performed without transfusion support in JWs with acceptable bleeding complications. Though demonstrating a TRM which is higher than that of the national average this appears acceptable for this unique patient population. Furthermore the bloodless approach may be appropriate in a select patient population undergoing HDC followed by ASCT, an approach which would reduce blood transfusion and its associated complications through the utilization of techniques and alternatives such as erythropoietin, aminocaproic acid, phytonadione and iron. Additionally the absence of bleeding complications at platelet counts > 5 x 103/μL, suggest use of a prophylactic platelet transfusion trigger of ≥ 5 x 103/μL, may be appropriate in select patients. | | No. | Median | Range | | ----------------------------------------------------------------------------------------------- | --------------- | ------------ | --------------------- | | Neutrophils | | | | | Days to ANC ≥1,000/mL | 125 | 10 | 4 - 19 | | Hemoglobin | | | | | Hemoglobin at onset of conditioning, g/dL | 125 | 11.8 | 7.0 – 11.8 | | Hemoglobin decrease to nadir, g/dL | 124 | 4.9 | 0.5 – 10.2 | | Hemoglobin nadir, g/dL | 123 | 7.0 | 2.0 – 11.6 | | Duration of grade 3/4 anemia hemoglobin < 8 g/dL | 125 | 9 | 1 - 28 | | Hemoglobin at day +30, g/dL | 98 | 10.9 | 3.5 – 14.9 | | Platelets | | | | | Platelets at onset of conditioning, /mL | 124 | 148 | 65 - 502 | | Platelet nadir, /mL | 123 | 5 | 1 - 50 | | Duration of Grade 4 thrombocytopenia platelets 20,000/µL | 125 125 | 4 11 | 0 – 20 0 - 23 | | Platelet count at day + 30, /mL | 97 | 137 | 17 - 557 | Table 1. Engraftment Parameters Disclosures No relevant conflicts of interest to declare.

Introduction High dose chemotherapy (HDC) followed by autologous stem cell transplant (ASCT) is considered the standard of care for patients with high-risk or relapsed lymphoma and multiple myeloma (MM). With most patients requiring both red cell transfusion ,and platelet support until marrow engraftment. Jehovah’s Witnesses (JW), based on religious convictions, refuse blood products, and therefore are frequently denied transplants in most centers, due to the presumed fear of death from bleeding and anemia. We present a series of 119 JW diagnosed with lymphoma (n= 54), (MM) (n= 63) and amyloidosis (n=2) who received treatment with HDC and ASCT without transfusion support. Methods All JW undergoing HDC and ASCT at Pennsylvania Hospital between May 1996 and March 2013 were included. Patients were primed pre-transplant with IV iron and erythropoietin to a target Hemoglobin (Hb) > 11g/dl.Cryopreservation of collected cells, was performed using normal saline and albumin instead of fresh frozen plasma. Post apheresis, HDC was delayed to allow Hb levels to rise to ≥ 11 g/dl and platelets ≥100,000. Post-transplant, patients received granulocyte colony-stimulating factor, erythropoietin and initially interleukin-11 which was later discontinued, as there was no benefit observed in the length of time to platelet engraftment. Thrombocytopenia was managed with antifibrinolytic agents (Amicar) and vitamin K, the avoidance of anticoagulation and aspirin, and rarely cryoprecipitate, desmopressin, and nasal vasoconstrictors. Results Engraftment The median number of days to neutrophil engraftment, with absolute neutrophil count ≥1,000/μL, was 10.0 days. The median Hb at the onset of chemotherapy was 11.8 g/dL, (range 7-15.3 g/dL), and the average decrease in Hb was 5.0 g/dL, with an average nadir of 6.8 g/dL. The median number of days with Hb under 8 g/dL was 5.5 days. The median platelet count at onset of chemotherapy was 148 x 103/μL (range of 65 to 502 x 103/μL). The median number of days with a platelet count under 10 x 103/μL was 3.0 days (range 0 to 14 days) with a median platelet nadir of 4.0 x 103/μL (range 1-50 x 103/μL). Patients with lymphoma experienced a lower drop in Hb post cytotoxic regimen than myeloma patients (ΔHb = 4.5g/dl for MM, 6.0g/dl for lymphoma, p < 0.05).The average length of stay (LOS) was 19.0 days. Bleeding Complications Bleeding complications were classified using the WHO criteria. Patients with platelet counts greater than 5 x 103/μl experienced no bleeding complications or death due to hemorrhage. There was one grade 4 hemorrhage, a temporal infarct leading to temporary vision loss and confusion, one grade 3 hemorrhage, a major gastrointestinal bleed, and one grade 2 hemorrhage which was hematuria. Sixteen patients experienced grade 1 bleeding episodes consisting of subconjunctival hemorrhage (n=5), epistaxis (n=6), minor vaginal bleeding (n=2), minor oral bleeding (n=1) a thigh hematoma (n=1), and a minor retinal bleed (n=1). Cardiac Complications Forty two of the one hundred and nineteen patients who underwent HDC and ASCT, experienced cardiac complications.These included new onset arrhythmias (n=19), profound hypotension (n=15), congestive heart failure (n=10) and acute myocardial infarction (n=1). The mean Hb nadir for patients who experienced a cardiac complication was 6.6 g/dL .Additionally the median age was 56 years (range 21-71years) and the average change in hemoglobin was 5.0g/dl. Mortality The 100 day transplant related mortality was 5%.The six deaths recorded were due to sepsis, multi-organ failure due to pancytopenia and cardiac events. Conclusion Based on our study we conclude that HDC followed by ASCT, can safely be performed without the need for transfusion support, with low mortality rates and low incidences of major bleeding complications .Anticipated anemia may be managed by ensuring priming of Hb with the use of IV iron and erythropoietin to Hb ≥11 g/dl, and simple patient blood management techniques. Thrombocytopenia may be managed similarly, by allowing platelet recovery post apheresis to ≥ 100, 000. We also believe that Amicar and Vitamin K offer as good and effective, an alternative to prophylactic platelet transfusion in the management of thrombocytopenia. Additionally these agents may be used to achieve homeostasis in patients who develop platelet refractoriness, and similarly the use in all transplant patients may be appropriate. Disclosures: No relevant conflicts of interest to declare.