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Psoriasis is a skin condition that affects over 100 million people worldwide, while multiple myeloma (MM) accounts for 10% of all hematologic malignancies in the US. There has been limited research on the intersection of psoriasis and MM, and clinicians often face difficult decisions in treating patients diagnosed with both conditions. For instance, the management of psoriasis with systemic immunotherapies in MM patients can be challenging because of concern about immunosuppression and possible worsening of MM. Online crowdsourcing platforms have recently become innovative tools that can actively empower patients in scientific research by enabling the contribution of health data. One such platform, HealthTree®, helps MM patients find optimal myeloma treatments and has registered > 6000 patients, many of whom have uploaded medical records and genetic profiles. By taking advantage of patient health data available on HealthTree, researchers can gain a greater understanding of the clinical characteristics and treatment responses of patients diagnosed with psoriasis and MM. In this case series, we first report a psoriasis and MM patient treated with the IL-17 inhibitor ixekizumab who demonstrated a temporary, 2-month improvement in MM biomarkers (M-protein, kappa, and kappa:lambda ratio). We then report on the clinical characteristics of 18 patients with verified profiles on HealthTree indicating concurrent psoriasis and MM conditions. We surveyed gender, age, psoriasis type, psoriasis treatment history, myeloma type, myeloma genetic features, and myeloma association with bone damage, hypercalcemia, or osteopenia. Four patients were treated with systemic immunomodulators for psoriasis, with responses suggesting that these therapies did not worsen MM progression. Our results validate crowdsourcing as a way to assess patient demographics and treatment responses for use in dermatology research. We examine the demographics of patients diagnosed with psoriasis and MM and investigate the use of systemic immunomodulators for treatment of psoriasis in MM patients. Electronic supplementary material The online version of this article (10.1007/s13555-020-00416-5) contains supplementary material, which is available to authorized users.

PURPOSEThe study of rare diseases, such as multiple myeloma (MM), often experiences unique research hurdles that can delay or prevent lifesaving discoveries. HealthTree Cure Hub is a first-in-class software program designed to overcome these potential research hurdles.METHODSWe assessed whether HealthTree Cure Hub improved four commonly experienced research hurdles such as (1) small numbers of patient accrual to clinical trials and research studies, (2) shallow and isolated data sets, (3) high costs to answer research questions, and (4) lack of long-term follow-up patient data.RESULTSAs of June 2021, HealthTree Cure Hub, with its unique portal features, has attracted 9,225 patients with MM and diverse demographic backgrounds. While completing an online health profile, patients shared comprehensive data, as well as provided consent to contribute data from electronic medical records. Portal use answered research questions using patient-driven real-world data. This also cultivated relationships with patients and established communication channels that enabled continual patient contact to allow for long-term follow-up.CONCLUSIONThese results suggest that a patient-driven data capture tool such as HealthTree Cure Hub will help alleviate common research hurdles, which, in turn, will accelerate MM research, develop new hypotheses, and ultimately improve survival.

BACKGROUND: Learning about a new multiple myeloma (MM) or smoldering MM (SMM) diagnosis is an important but difficult first step of a cancer journey. However, the education process can be overwhelming, especially within ethnic minorities and the medically underserved. Moreover, recent studies suggest that too much information may lead to confusion, frustration, and could negatively impact the decision-making process. Therefore, the primary purpose of this survey was to capture the common questions and concerns of MM and SMM patients when they were newly diagnosed and since diagnosis within the Mexican, Hispanic and Latino ethnicities and compare their responses to non-Hispanic or Latino ethnicities. METHODS: We utilized HealthTree® Cure Hub and invited patients with MM or SMM to participate in an online survey consisting of selecting from a list of 20 topics of what their questions were at diagnosis and since diagnosis. RESULTS: Of the 36 myeloma patients identified as Mexican, Hispanic or Latino 86% had MM and 14% had SMM, 95% were diagnosed before 2019, 91% saw a specialist, 66±8 years, 53% female, 56% retired, 31% reported currently working, and 97% had health insurance. The non-Hispanic or Latino group consisted of 248 patients, 78% with MM and 26% with SMM, 81% were diagnosed before 2021, 78% saw a specialist, 65±8 years, 58% female, 52% retired, 29% reported currently working and 98% had health insurance. The top 5 questions at diagnosis were identical between groups: What are the myeloma treatment options?, What is my life expectancy?, What is myeloma?, What can I expect during treatment?, and Can myeloma be treated? However, since diagnosis the top 5 concerns changed and a key divergence between groups occurred. Importantly, the top new concern for both groups was, Is a clinical trial right for me?, and both groups added the question: What side effects would I experience? The two groups did differ, the non-Hispanic group added one additional question: What can I do to prevent further spread of the disease? While, in contrast, the Mexican, Hispanic and Latino group added two questions, within a similar domain, which was not previously observed: Should I consider a second opinion?, and Does my doctor have sufficient experience? DISCUSSION & CONCLUSION: These results identified major concerns of MM and SMM patients at and since diagnosis and this study documents critical ethnicity divergence that occurs as patients become more experienced with managing their myeloma. Interestingly, both ethnicities shared the same top 5 concerns at diagnosis and had some similarities of new concerns since diagnosis. However, the Mexicans, Hispanics, and Latinos reported new concerns that involved questioning their doctors’ competence and the desire of a second medical opinion for medical decisions. In conclusion, although ethnic groups largely have similar questions and concerns at and since diagnosis, Mexican, Hispanics and Latinos express interest in assuring they are being treated by experienced doctors and highly value second medical opinions. Citation Format: Jay R. Hydren, Nathan W. Sweeney, David F. Barton, Jorge Arturo Hurtado Martinez, Jennifer M. Ahlstrom. What are the top myeloma patient concerns at and since diagnosis of Mexicans, Hispanics and Latinos? [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr A004.

Background: Although Black Americans have 2-3 times multiple myeloma (MM) incidence and mortality as compared to Whites, increasingly research is demonstrating that many may have genetic characteristics that have better survival outcomes. Yet delayed diagnoses and inappropriate first lines of therapy often wipe out whatever “advantages” they may have had, keeping mortality statistics higher than would be expected (PMID: 25469920). For underserved populations, a number of commonly accepted disparities exist in myeloma, and more broadly, cancer care. Patients who receive treatment by a high-volume provider (myeloma specialist) is a factor that can help patients with MM to have a longer life expectancy (PMID: 31487686). Therefore, we analyzed whether there is a disparity between race and receiving care from a myeloma specialist which may contribute to the differences in survival that is being seen. Methods: Validated real-world (RW) MM patient data was collected through HealthTree Cure Hub for Multiple Myeloma (healthtree.org). We examined the patient’s race which was either Caucasian American or Black American and whether or not they were being treated by a myeloma specialist. The association between race and specialist was examined by a chi-squared (X2) test. Results: In this retrospective analysis of 2,871 MM patients, we compared Caucasian Americans (n= 2716) and Black Americans (n=155). Our analysis revealed a significant association between the two races and whether or not they had a myeloma specialist, X2(1, N = 2,871) = 5.85, p = 0.015. Black Americans were less likely to be treated by a myeloma specialist. Conclusion: The findings of this RW analysis identify a glaring disparity in Black American MM patients and receiving care from a myeloma specialist. Addressing the underlying cause of the findings could extinguish other MM-related issues, such as delays in getting a correct diagnosis, lack of access to myeloma specialists, and many other non-medical issues leading to less-than-optimal outcomes from the majority of these Black American patients. Citation Format: Christian S. Cheung, Nathan W. Sweeney, Zena M. Tiu, Cynthia Chmielewski, Jennifer M. Ahlstrom. Comparison of multiple myeloma provider for Black Americans and Caucasian Americans [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 6287.

Background: Multiple Myeloma (MM) is a rare cancer affecting plasma cells. Patients with MM have several lines of treatment options and overall survival has increased with current treatments, nonetheless, MM remains currently incurable. It has been recently noted that ABO blood types may influence the survival of MM patients (PMID: 33362882). The purpose of this study is to find if there is a relationship between the survival of MM patients and their ABO blood type. Methods: Patients were drawn from the self-reported HealthTree Cure Hub database which included 1,173 individuals. 458 patients reported having A blood type, 56 patients reported having AB blood type, 155 patients reported having B blood type, and 504 patients reported having O blood type. Patients who did not report a blood type were excluded from this analysis. An analysis of variance was conducted to analyze the relationship between the survival time (total time to next treatment) and a patient's ABO blood type. A t-test was conducted to compare the survival time of O blood group with other blood types. Additionally, an analysis of variance was conducted to determine the relationship between ABO blood groups and a patient's likelihood of being considered high risk. Results: We found that there was a relationship between total time to next treatment and ABO blood type. On average the total time to next treatment of MM patients with O blood type was longer compared to other blood types with an average of 2027 days. Patients with A blood type had an average of 1762 days, AB blood type had an average of 1882 days, and B blood type had an average of 1747 days. While the difference in average survival time was not statistically significant (p-value = 0.138), it is still worth noting that there is a difference in average total survival time for patients with O blood type. We further compared the average total time to next treatment between O blood group and all other blood types. We saw that there was a statistical significance (p-value = 0.040) and concluded that on average the survival time of patients with O blood type is higher than other blood groups by 250 days. We also investigated whether or not patients in certain ABO blood groups are more inclined to have high-risk mutations. We categorized patients as high risk and standard risk-based on guidelines defined by Mayo Clinic’s mSMART. We found that there was no statistical significance (p-value = 0.797) and concluded that patients are equally likely to be considered high risk for all ABO blood groups. Conclusion: Our results indicated that MM patients with blood type O have a longer survival time on average than patients with blood type A, AB, and B. We saw that a patient’s likelihood of having a high-risk mutation is the same across all ABO blood groups. Our results may help lead to further research investigating why despite having a similar proportion of patients who are considered high risk, patients with O blood type differ in average survival time. Citation Format: Zena M. Tiu, Nathan W. Sweeney, Christian S. Cheung, Cynthia Chmielewski, Jennifer M. Ahlstrom. Relationship of ABO blood groups and length of survival of multiple myeloma patients [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 6286.

8046 Background: As treatments advance in multiple myeloma (MM) and increasingly deeper and longer responses are achieved, the definition of what a cure is becomes increasingly relevant. While many physicians quote that patients may achieve a “functional cure”, understanding the patient perspective on the concept of cure has yet to be explored. Methods: HealthTree Cure Hub by the HealthTree Foundation represents an online portal for patients with plasma cell dyscrasias to help navigate their disease. It is the largest single database of patients with multiple myeloma with over 10,200 patients as of January 2022. Using this platform, we surveyed patients online from November 11th 2021 to Feb 7th 2022. Varying scenarios incorporating toxicity, disease status, and being on/off treatment were presented, and participants were asked to rate them from 1-5, with 5 being an ideal cure. Patient awareness of the term functional or operational cure was also. Results: A total of 1525 participants completed the survey. Table lists characteristics of the patients who completed this survey. The majority of the patients were female (55.5%), college educated (88.5%) and non-Hispanic White (70.7%). Most patients rated being off treatment permanently and having no evidence of disease as a cure (1116/1469, 75.5%), with a median score of 5 amongst respondents, indicating an ideal version of cure. Continuing to take the same pill or injection with significant toxicity and no evidence of disease had a median score of 1, a score lower than either “continuing to take same pill or injection without significant toxicity even in the evidence of disease” (median score 2) or “stopping treatment permanently even with some detectable disease” (median score 2). The majority of patients (76.3%) reported being unfamiliar with the term functional or operational cure. Conclusions: In the first study of patients with plasma cell dyscrasias in which patients were asked about their perceptions of what a cure is, our results highlight that drug toxicity and being on treatment profoundly impacts patient's perception of cure. Furthermore, most patients are not familiar with the term functional or operational cure. Future efforts should recruit more diverse patient populations and incorporate patient preferences in approaches to defining cure in myeloma, as well as explaining cure in easily comprehensible terms to patients. [Table: see text]

8058 Background: Previous studies have observed smoldering multiple myeloma (SMM) patients with a biomarker criteria of > 20% bone marrow plasma cells, > 2 g/dL M protein spike, and > 20 free light chain ratio, also known as 20/2/20, are at a higher risk of progressing to multiple myeloma (MM) than others. These findings have ignited interest in pursuing early intervention for these high-risk patients. However, we asked if early intervention would be beneficial for all SMM patients regardless of the progression risk level. Methods: We utilized real-world data from HealthTree Cure Hub for Multiple Myeloma to first, determine whether 20/2/20 resulted in a higher risk of progression and second, analyze whether early intervention delayed progression from SMM to MM. A 2-sample t-test was used to compare 20/2/20 to non-20/2/20 patients, as well as in the comparison between SMM patients who received early intervention with treatment to without early intervention. Results: We found that patients who met at least two of the criteria of 20/2/20 had a tendency to progress to MM 35% faster than patients who did not meet the criteria (n = 36, p-value < 0.10). While not significant, it’s still worth noting that there is a difference in the mean time to progression for these patients. Next, we found SMM patients who do not receive early intervention with treatment develop MM two times faster than those who do receive early intervention with treatment, regardless of progression risk level (n = 129, p-value < 0.001). Conclusions: Our results revealed that at least two of the biomarker criteria could aid in the identification of patients with a higher risk of progression. However, a casual approach of “sit and wait” for patients to develop 20/2/20 is not warranted since our findings revealed that all SMM patients benefited from treatment intervention regardless of the progression risk level.

e20003 Background: People that live in rural areas experience significant health disparities from higher incidences of disease and disability, increased mortality rates, and lower life expectancies. Rural risk factors for health disparities include geographic isolation, lower socioeconomic status, limited access to healthcare specialists and sub-specialists, and limited job opportunities. Interestingly, we often see other, non-white, races experience delays in care, are under-treated, and lack of access to MM specialists. We, therefore, investigated whether there was a relationship between race and where one lives geographically. Methods: Validated real-world (RW) MM patient data was collected through HealthTree Cure Hub for Multiple Myeloma (healthtree.org). We examined the patient’s race which was either Caucasian American (White) or any other race (Black American, Asian, American Indian, East Indian, Middle Eastern, or Native Hawaiian) which was categorized as “non-White” and where they lived geographically (Rural, Urbanized Cluster, or Urban Areas). The association between race and geographic classification was compared by using a chi-squared test. Results: In this retrospective analysis of 2,687 MM patients, we compared the geographical classification of Whites (n = 2403) and non-Whites (n = 284). Our analysis revealed a significant association between the two groups and where they lived with a chi-square value of 20.455 (2, n = 2,687, p < 0.001). We found that Whites are 1.9 times more likely to live in urbanized cluster areas and 2.7 times more likely to live in a rural area compared to non-Whites. Conclusions: The results of this RW analysis identified a disparity among races and where one lives geographically. While there is strong evidence of health disparities our findings revealed that where one lives geographically is not a probable reason why non-Whites experience delays in care, are under-treated, or lack access to MM specialists.

Background Plasma cell disorders (PCDs) are chronic incurable conditions with an opportunity to positively impact outcomes with nutritional changes. Epidemiologic studies show that inflammatory/insulinemic diets are linked to PCDs (Lee IJC 2020), while vegetarians/vegans have a reduced risk (Key AJCN 2014). MGUS/SMM present a unique opportunity for early intervention, given the standard of care is observation. Though patients often inquire about the role of nutrition and whether they should alter habits to eat healthfully, their oncologists are frequently not prepared to address these concerns. The purpose of this survey was to provide insights into patient nutrition perceptions/practices and identify areas for further research. Methods We utilized HealthTree® Cure Hub (HealthTree® Foundation, Lehi, Utah, USA) and invited participants with PCDs to answer questions pertaining to their diet/nutrition and related experience with their oncologist in an online survey. De-identified aggregated responses were reviewed. Results Of 421 participants, 82% reported having dietary questions post-diagnosis, yet 23% stated this was not addressed by their oncologists despite asking. Among those who discussed it with their oncologist, 50% received no specific advice or were recommended a ‘balanced diet’ lacking details. Of the participants that received clear guidance from their oncologists, 88% attempted to follow it, reflecting the positive influence their oncologists can have. Lack of knowledge/conflicting advice were barriers to change for 23%. Although the American Institute of Cancer Research (AICR) has published dietary guidelines, only 34% were aware of them. Patients also more frequently reported following a healthier diet after diagnosis – 75% pre-diagnosis vs 88% post-diagnosis. 78% patients with unhealthy diets pre-diagnosis improved their diet post-diagnosis and 7% with healthy diets pre-diagnosis worsened their diet post-diagnosis. Post-diagnosis, more patients reported consuming whole fruits and vegetables ≥1 times/day and whole grains and seafood ≥3 times/week. Post-diagnosis dietary changes were based on online/media information and advice from non-medical friends in 47%, compared to advice from PCPs/oncologists/nutritionists in 22%. Conclusions Patients with PCDs are interested in dietary advice and make dietary changes when faced with a cancer diagnosis. Most patients currently receive this advice from non-medical sources and report barriers related to lack of consistent information. Oncologists who provide clear guidance can positively impact dietary changes among patients. Our results reflect a missed opportunity between patients’ need for dietary advice and the potential for oncologists to provide helpful counsel. Our findings highlight a need for further research into standardized guideline (AICR) implementation as well as for the development of PCD-specific guidelines. Further disease focused dietary studies are needed to fill this gap.

Background: Patients with multiple myeloma (MM) are uniquely susceptible to viral and bacterial illnesses, including COVID-19, due to their immunocompromised state, age, treatments, and comorbidities. With the advent of COVID-19, changes to treatment were recommended whenever possible, in order to reduce visits to the clinic. The total effect of these changes on cancer patients with multiple myeloma remains unclear. The aim of this project was to assess treatment management by changes to treatment of patients with MM during the COVID-19 pandemic. Methods: We utilized HealthTree ® Cure Hub for Multiple Myeloma (healthree.org) and invited patients with active MM cancer or precursor conditions to participate in an online survey. We analyzed patient responses to questions regarding their myeloma treatments during the COVID-19 pandemic. Results: 978 MM patients participated in the survey between February to June 2021. Since March 2020, 151 patients (15%) either delayed, postponed, or stopped a myeloma treatment because of COVID-19. The four most common treatments were daratumumab (20%), lenalidomide (15%), stem cell transplant (13%) and zoledronic acid (11%). There were 110 patients that canceled a planned myeloma treatment. Of these patients, 55 (50%) canceled a planned chemotherapy, 15 (14%) canceled a stem cell transplant, 1 (1%) canceled radiation and 39 (35%) indicated other. Eight patients replaced an intravenous or subcutaneous treatment with an oral treatment because of COVID-19. There were 9 patients that started a new myeloma treatment because of COVID-19, the most common being daratumumab (44%), ixazomib (22%), lenalidomide (22%) and carfilzomib (11%). Finally, 15 patients had their lenalidomide (50%), steroid (42%) and carfilzomib (8%) dose changed. Conclusions: Our results show that decision-making regarding treatment changes were made on an individual basis and that patients who required a change in treatment were the minority. Aggregating real-world data can provide evidence that despite the changes, patients with MM still received and efficacious treatment and avoided putting these patients at risk or mortality. Disclosures Ahlstrom: Bristol Myers Squibb: Other: Patient Advisory; Janssen: Other: Patient Advisory; Pfizer: Other: Patient Advisory; Takeda: Other: Patient Advisory.

Background: A question that was commonly investigated during the COVID-19 pandemic was which clinical characteristics would make one more susceptible to contracting COVID-19? This was especially a concern for those who were considered "high risk" as they would be more prone to suffering from more severe COVID-19 symptoms and at times even death. In this abstract, we investigated which clinical characteristics of multiple myeloma (MM) cancer patients could make them more prone to contracting COVID-19. We also investigated which of these conditions make patients more at risk for experiencing more severe COVID-19 symptoms (PMID: 32950467, PMID: 32353254). Knowing what medical conditions that would make a patient more at risk for contracting or experiencing a more severe case of COVID-19 has been a concern for many, especially for those who suffer from more severe health conditions such as cancer. Methods: MM patient data and demographics were collected through HealthTree ® Cure Hub for Multiple Myeloma. We analyzed medical conditions including hypertension, heart condition, neuropathy condition, and BMI. We also looked into lung condition, kidney condition, diabetes, stroke, smoking history, drug use history, HIV, and Mediterranean descent but did not include in the figure due to small population sizes. We determined whether a patient had to be hospitalized, admitted to the ICU, needed oxygen therapy, or needed a D-dimer test as a severe COVID-19 case. Multivariable logistic regressions were performed to quantify the risk for contracting COVID-19 for patients with specific medical conditions and which medical conditions made COVID-19 positive patients more at risk for experiencing a more severe case of COVID-19. Results: Out of the 962 patients that were involved in this study, we found that patients who were overweight were 2% more likely to contract COVID-19 than those who were not overweight. Other medical conditions did not increase the risk of contracting COVID-19. Furthermore, there were 35 patients that were involved in investigating how certain medical conditions may affect the severity of COVID-19 symptoms. We found that overweight patients were 12% more likely to suffer from more severe COVID-19 than those not overweight. Patients who suffered from neuropathy conditions were 3% more likely to experience a more severe COVID-19 case than those who do not have that condition. It is important to note that these results were not statistically significant, although are still informative. Conclusion: Our results show that MM patients who are overweight have a greater tendency to not only contract COVID-19 but experience a more severe case of COVID-19. Somewhat surprisingly, we found that patients who experience neuropathy, common among MM patients, had a higher tendency to experience a more severe case of COVID-19. We speculate whether MM patients, a high-risk group due to their immunocompromised state, took extra care to follow safety recommendations and caution to avoid contracting COVID-19. A logical next step would be to compare medical condition interactions to examine whether patients with more than one condition experience additive or synergistic risk, as well as comparing out results to other high-risk groups. These findings, although not statistically significant, may help MM patients identify which of their own medical conditions may put them more at risk for contracting COVID-19 and thus take precautionary measures. Figure 1 Figure 1. Disclosures Ahlstrom: Takeda: Other: Patient Advisory; Pfizer: Other: Patient Advisory; Janssen: Other: Patient Advisory; Bristol Myers Squibb: Other: Patient Advisory.

Background: Since the start of the COVID-19 pandemic, "high-risk" patients, such as cancer patients, have had to reconsider their current medical treatments and other treatment alternatives to best minimize their risk for contracting COVID-19. Lenalidomide has immunomodulatory properties that stimulate the production of T-cells which help combat against infections which may include diseases such as COVID-19. In this abstract, we investigate whether lenalidomide protects multiple myeloma (MM) patients from contracting COVID-19 and whether lenalidomide decreases the severity of COVID-19 events (including hospital or intensive care unit [ICU] admissions, and need of assisted ventilation) for patients that contract the virus (PMID: 32950467, PMID: 32353254). Methods: MM patient data was collected through HealthTree ® Cure Hub for Multiple Myeloma (healthtree.org) and the relative risk was calculated to compare the risk of contracting COVID-19 between patients taking lenalidomide and those who were not at the time of contracting COVID-19. The odds ratio was calculated to measure lenalidomide's effect on the severity of COVID-19 if contracted. These events include whether a patient was hospitalized, had to go to the ICU, or required oxygen therapy. Results: There were 1,123 patients involved in comparing lenalidomide with the risk of contracting COVID-19, including patients that never tested positive for COVID-19. Surprisingly, our results showed that patients who are taking lenalidomide have a 10% higher risk for contracting COVID-19 than those who are not; however, these findings were insignificant. Furthermore, 40 patients were involved in investigating lenalidomide's effect on decreasing severe COVID-19 symptoms for MM patients. Our results showed that the odds of patients experiencing severe COVID-19 were 1.95 times more for those on lenalidomide than those who were not. Conclusions: Despite the insignificance of lenalidomide during COVID-19, our results indicated that taking lenalidomide may not be beneficial in lowering the risk for MM patients in contracting COVID-19. Furthermore, lenalidomide may also not decrease the severity of COVID-19 symptoms for MM patients that did contract COVID-19. Our results may help MM patients and their providers decide whether to continue their use of lenalidomide or to seek alternative treatment options. Disclosures Ahlstrom: Pfizer: Other: Patient Advisory; Janssen: Other: Patient Advisory; Takeda: Other: Patient Advisory; Bristol Myers Squibb: Other: Patient Advisory.

Purpose Nonalcoholic fatty liver disease (NAFLD) is considered the most common form of silent liver disease in the United States and obesity is associated with increased risk of NAFLD. Obstructive sleep apnea (OSA) which is common in obese individuals is associated with a greater incidence of NAFLD, which in turn, increases the risk for hepatocellular carcinoma (HCC). It is unclear how obesity, OSA and NAFLD interrelate nor how they collectively contribute to an increased risk for developing HCC. Patients and methods Male BALB/c mice were exposed to diethylnitrosamine and phenobarbital followed by 48 weeks of either standard chow diet (chow), chow with hypoxia, high-fat diet, or a combination of hypoxia and high-fat diet. We noninvasively monitored tumor development using micro-CT imaging. We tracked the total weight gained throughout the study. We evaluated liver histology, fat accumulation, carbonic anhydrase 9 (CA9) and hypoxia-inducible factor 1-alpha (HIF-1α) expression, as well as, serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Results A high-fat diet without hypoxia led to the development of obesity that induced hepatic steatosis and promoted tumorigenesis. Animals on a high-fat diet and that were also exposed to hypoxia had lower total weight gain, lower steatosis, lower serum AST and ALT levels, and fewer number of hepatic adenomas than a high-fat diet without hypoxia. Conclusion These findings suggest that hypoxia abrogates obesity, hepatic steatosis, and hepatic tumorigenesis related to a high-fat diet.

Micro-computed tomography (micro-CT) coupled with tissue, or vascular, specific contrast agent has emerged as a powerful tool for detecting and monitoring tumor growth in the liver of murine animals. Intravenous injections of contrast agents can be technically challenging and lead to errors that can considerably influence the outcome of a preclinical study, prompting an alternative method. Here we assessed the effectiveness of intraperitoneal injections of polyiodinated triglycerides emulsions (Fenestra LC) in micro-CT imaging of young SCID (8 weeks) and old BALB/c (48 weeks) mice with xenograft or carcinogen-induced liver tumors, respectively, and determined an optimal acquisition time. Utilizing an intraperitoneal injection is a viable alternative administration route for using Fenestra in detection and quantification of murine liver tumor burden.

Background:The rapid outbreak of coronavirus disease 2019 (COVID-19) led to delays of non-urgent or routine medical care. Regulatory waivers and policy changes from the Centers of Medicare and Medicaid Services (CMS) for the use of telehealth came as a solution to help fight the outbreak. The aim of this project was to survey the change in the frequency of use of telehealth services among multiple myeloma (MM) patients during the COVID-19 pandemic. Methods:We utilized HealthTree Cure Hub For Multiple Myeloma (healthree.org) and invited patients with active MM cancer or precursor conditions to participate in an online survey. We analyzed patient responses to doctor visits, the use of telehealth before and after the COVID-19 pandemic, and whether they had sufficient access to their doctor. Results:1,301 MM pts participated in the survey between April 15, 2020, and June 8, 2020. During the pandemic, 36% of patients indicated visiting with their physician less often than before, 2% visited more often, and 62% had no change in the frequency of their visits. The percent of patients responding “Sometimes” or “Yes” to the use of telehealth are reported here. Before the pandemic, 10% of patients used telehealth, while 62% of patients indicated using telehealth during the pandemic, a 523% increase. When asked if they had sufficient access to their MM healthcare provider 90% of patients indicated that they did, while 10% indicated they did not. Conclusions:There were significantly fewer in-person visits during the COVID-19 pandemic likely due to the CDC-recommended physical distancing practices. During this time, telehealth use among MM patients dramatically increased compared to telehealth use before the pandemic. It is reasonable to assume that patients indicated having sufficient access to their healthcare provider as a result of patients receiving care through telehealth visits. The authors encourage readers to think more broadly about the benefits of telehealth. Maintaining sufficient access to one healthcare provider addressed in this abstract is only a fraction of the benefits telehealth offers. MM is a rare cancer and as a result, some states have few if any specialists. Maintaining telehealth policy changes made during the pandemic would remove geographical barriers and open access to specialists across the country. Citation Format: Nathan W. Sweeney, Scott R. Goldsmith, Jennifer M. Ahlstrom. Telehealth use among multiple myeloma patients during the COVID-19 pandemic [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 716.

e20024 Background: Chimeric antigen receptor (CAR) T-cell therapies are in clinical development for multiple myeloma (MM). Patient-reported outcomes (PRO) can provide valuable insights into how patients perceive the relative risks and benefits of these new therapies. This study aimed to evaluate CAR T-cell therapy in relapsed/refractory MM (RRMM) patients. Methods: We utilized HealthTree Cure Hub for Multiple Myeloma to analyze patient-reported data from 17 patients who participated in CAR T-cell clinical trials. In this study, we examined total prior lines of therapy, time to next treatment (TNT), overall survival (OS), patient-reported toxicity and severity, and patient-reported outcomes (myeloma reduction or no myeloma reduction). The Kaplan-Meier model was used to calculate overall survival. The severity of toxicity was assessed using a 1 to 10 scale (1 = minimal and 10 = severe). Results: Our analysis of the 17 patients found a median of 10 lines of therapy prior to CAR T-cell treatment. Ten patients had no new treatments to report at the time of this study, 5 patients reported new treatment with a median TNT of 15.9 months, and for 2 patients we did not have data. The median OS was 24 months (95% CI 21-30 months). The probability that a patient remained alive at 2 years was 0.48 (95% CI: 0.195, 1). Four of the 17 patients died with a median of 22.5 months post-CAR T-cell therapy. Two of these patients died without reporting a change in treatment. There was a total of 36 different side effects reported by patients as a result of the therapy. Table lists the side effects experienced by 2 or more patients and the corresponding average severity. Finally, 76% of patients treated with CAR T-cell therapy reported a reduction in their myeloma, four of these patients had m-protein levels reported and saw an average decrease of 93%. Of the remaining patients, three (18%) reported little to no reduction in their myeloma, and one patient (6%) did not know their response at the time of this analysis. Conclusions: Our investigation of patient-reported results suggests an emerging and viable immunotherapy treatment option for RRMM, with encouraging outcomes and manageable side effects. Future directions include analysis of genetics and treatment options post CAR T-cell therapy. These data highlight the expedited benefit of using PROs via an online platform, like HealthTree Cure Hub, to assess new therapeutics in the research community.[Table: see text]

e20022 Background: Patient-reported data play a critical role in assessing clinical benefit from therapeutic interventions and are increasingly used in clinical trials. Internet-based platforms such as HealthTree Cure Hub for Multiple Myeloma ( www.healthtree.org ) provide the opportunity to obtain such real-world patient-reported data, while also providing valuable insights into high-yield areas to focus on quality-improvement efforts. For example, proteasome inhibitor (PI)-based maintenance after autologous stem cell transplantation (ASCT) is a consensus recommendation in many practice guidelines for high-risk multiple myeloma (MM) yet real-world adherence to this practice remains uncertain (PMID 23541011, 30932732). Methods: We examined post-ASCT maintenance therapy in patients with high-risk MM, as defined per mSMART criteria, using patient-reported treatment data from the HealthTree Cure Hub for Multiple Myeloma database. Patients who received an ASCT prior to 2014 were excluded. Results: Our analysis identified 110 MM patients with high-risk MM. Of those, only 48 (44%) received PI-based maintenance therapy. Additionally, 60 (55%) received IMiD (immunomodulatory imide drug) maintenance, 1 (< 1%) received ‘other’, and 1 (< 1%) did not report maintenance therapy. Conclusions: The benefits of PI-based maintenance in MM are well established for high-risk MM. However, analysis of patient-reported data using an online patient portal, HealthTree Cure Hub for Multiple Myeloma, suggests a disparity between practice recommendations and real-world practice patterns. These findings, and others from online patient portals, can serve as a springboard in helping investigators to identify areas for quality-improvement initiatives.

e20044 Background: Recent advancements in the treatment of plasma cell disorders (PCD) have led to a revolution in treatment options. Despite improved outcomes, patients have unmet symptom management needs. Integrative medicine (IM) is a method for addressing symptoms in cancer, but its use and efficacy is poorly defined in PCD patients. This analysis describes the utilization of IM among myeloma patients and explores associations with symptom burden. Methods: For 3 months, a 70-question online survey was hosted on HealthTree.org, an online resource for myeloma patients and researchers created by the HealthTree Foundation. The survey included questions about demographics, PCD type, disease stage, complementary practice use, PHQ-2 score (depression screen), and quality of life (sum of 6 interference items; possible score range 0-6). Mean outcome values were compared between IM users and non-users using two-sample t-tests. Proportions of supplement users and IM users were compared between patients currently on myeloma-specific treatment and patients not currently on treatment using chi-square tests. Results: Of 195 total respondents, 17 were excluded for not completing the survey section on IM practices. Median age range was 60-69 years old, 61% were female, 91% were non-Hispanic white, and 57% were overweight or obese. Plasma cell subtypes were active myeloma (81%), smoldering myeloma (12%), MGUS (3%), amyloidosis (2%), and plasmacytoma (1%), and 72% of patients were currently on cancer-specific treatment. On a scale of 1-10 (1=very uncomfortable; 10=very comfortable), patients reported a mean score of 3.7 when discussing IM therapies with their oncologist. The top 10 IM modalities reported were aerobic exercise (83%), nutrition (67%), natural products (60%), strength exercise (52%), support groups (48%), breathing exercises (44%), meditation (42%), yoga (40%), mindfulness-based stress reduction (38%), and massage (38%). Those who participated in meditation had significantly higher PHQ-2 scores (worse depression) than non-participants (1.1 vs. 0.8; p=0.05). Users of support groups (3.4 vs. 2.7; p=0.04), medicinal marijuana (4.0 vs. 2.9; p=0.03), or vitamin C (3.6 vs. 2.7; p=0.01) reported higher mean interference (worse quality of life) than non-users. Compared to patients currently on cancer treatment for PCD, untreated patients were significantly more likely to use curcumin (58% vs. 41%; p=0.04) or green tea (44% vs. 17%; p

e20026 Background: Whether tandem autologous stem cell transplant (ASCT) is superior to single ASCT for new diagnosed multiple myeloma (MM) patients remains a subject of discussion in the era of novel agents. This project analyzed patient-reported outcomes to single ASCT and tandem ASCT utilizing an online patient-centered platform. Methods: We analyzed patient-reported treatment outcomes pertaining to tandem ASCT and single ASCT from HealthTree Cure Hub ( www.healthtree.org ). In this study, we examined whether patients reported a reduction or no reduction in their myeloma after their tandem or single ASCT. The association between stem cell transplant and myeloma outcome was compared by chi-squared test. Results: In this retrospective analysis of 945 MM patients, we compared two groups, those that reported receiving a tandem ASCT (n = 75) and those that reported receiving a single ASCT (n = 870). Our analysis revealed an association between patients who reported receiving a tandem ASCT and a reduction of their myeloma (chi-square (1) = 3.87, p = .04), compared to patients who reported receiving a single ASCT. Conclusions: Tandem ASCT was perceived by patients to be superior over single ASCT in regard to myeloma reduction for the HealthTree patient population. A more in-depth analysis of the patient-provided health data from HealthTree could aid in determining factors related to survival as well as help to quickly answer lingering questions related to tandem ASCT, such as timing, genetic factors, progression free survival, and more.[Table: see text]

e20025 Background: Patients with multiple myeloma (MM) are uniquely susceptible to viral and bacterial illnesses. In addition, MM and its treatments lead to immune deficiency, putting patients at a high risk for infection, including the novel coronavirus (COVID-19). The emotional impact of COVID-19 on high-risk groups, such as MM patients, remains unclear. The purpose of this project was to understand psychosocial distress and unmet needs among patients with active MM during the acute and chronic phase of COVID-19 and its impact in the United States. Methods: We utilized the HealthTree Cure Hub (healthtree.org) and invited patients with active MM cancer or precursor conditions to participate in an online CancerSupportSource distress screening questionnaire by the Cancer Support Community. Participants were asked to rate their level of concern (Not at All to Very Seriously) on 12 items assessing physical, psychosocial, and practical needs during the acute and chronic phase of the COVID-19 pandemic. De-identified responses were aggregated and reviewed. Results: 1,079 MM patients analyzed during the acute phase of the pandemic (April 15, 2020, to June 8, 2020) and 246 were analyzed during the chronic phase (January 8, 2021, to February 12, 2021). The percent of patients responding moderately to very seriously concerned are reported here. While eating and nutrition increased 3% from acute (71%) to chronic (74%) phases, physical needs overall decreased 2%. Psychosocial needs (worrying about the future, family concerns, feeling irritable, sad, nervous, or lonely, and relationship concerns) decreased 4% between the two phases, despite the 2% increase in problems with your spouse/partner. Additionally, practical needs (health insurance or money worries) decreased 4% between the acute and chronic phases of the pandemic. Conclusions: Respondents to our survey maintain a concern for eating and nutrition during the acute and chronic phases of the pandemic. Between the three types of needs examined in this survey, physical needs had the smallest change over time. This information can inform patients and medical professionals of the type of distress experienced by patients and help investigators assess the needs of the patient community to enhance patient outcomes.[Table: see text]

Background: The rapid outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to the delay of non-urgent or routine medical appointments, placing tremendous burden on cancer patients. Meanwhile, the emotional effect of the novel coronavirus (COVID-19) on high-risk groups, such as multiple myeloma (MM) patients, remains unclear. The purpose of this project was to understand psychosocial distress and unmet needs among patients with active MM during the acute phase of social distancing and COVID-19 impact in the United States. Methods: We utilized HealthTree (healthtree.org) and invited patients with active MM cancer or precursor conditions to participate in an online survey curated through a partnership with the Cancer Support Community (CSC). Participants were asked to rate their level of concern (Not at All to Very Seriously) on 12 items assessing psychosocial, practical, and physical needs (selected from CSC’s CancerSupportSource® distress screening tool) during the COVID-19 pandemic. De-identified responses were aggregated and reviewed. The survey was determined to be exempt by the Western Institutional Review Board. Results: 1,079 MM pts participated in the survey between April 15, 2020 and June 8, 2020. The percentages of patients responding moderately to very seriously concerned are reported here. Eating and nutrition (71%), sleep problems (49%), pain and/or physical discomfort (46%), and feeling too tired to do the things you need or want to do (44%) made up the physical/health concerns. Psychosocial/emotional concerns included worrying about the future and what lies ahead (46%), worry about family, children, and/or friends (44%), feeling irritable (37%), feeling sad or depressed (30%), feeling nervous or afraid (25%), feeling lonely or isolated (20%), and relationship problems with your spouse/partner (11%). Finally, 32% reported insurance or money concerns. Conclusions: Respondents to our survey were most concerned with eating and nutrition, sleep problems, pain and/or physical discomfort, and worrying about the future. Informing patients and medical professionals of physical and psychosocial distress experienced by patients could create a unified approach to decreasing distress levels and increase patient overall health, even during a pandemic or when care is delayed. Patient-reported surveys via an online portal, like HealthTree, can help investigators assess the patient community and result in hypothesis-generating research questions to enhance patient outcomes. Citation Format: Nathan W. Sweeney, Jenny Ahlstrom. Cancer-related distress among multiple myeloma patients during the COVID-19 pandemic [abstract]. In: Proceedings of the AACR Virtual Meeting: COVID-19 and Cancer; 2020 Jul 20-22. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(18_Suppl):Abstract nr PO-009.

e20565 Background: Multiple myeloma (MM) prognostic risk factors include cancer genetics as well as imaging characteristics. In order to engage the patient (pt) community regarding genetic testing and diagnostic imaging we utilized a patient-centered platform, HealthTree (www.healthtree.org), to evaluate the patient understanding of cancer genetic characteristics as well as evaluation of radiology methods used to evaluate their disease. Methods: An investigator-submitted online survey asking pts about myeloma genetic testing and imaging was fielded via HealthTree to 4,944 pts from May 10, 2019, to January 9, 2020. De-identified responses were aggregated and reviewed. The study was determined to be exempt by the Western Institutional Review Board. Results: 558 MM pts participated in the surveys. Pts who received more than one imaging or genetic test were able to indicate by selecting more than one option, this total response is indicated in the tables. Abbreviated questions and simplified responses are noted in the Table including: 1. At your diagnosis (or any time), did you receive any of the following tests to better understand the genetic profile of your disease? 2. At diagnosis (or any time), what imaging (radiology) tests were performed? Conclusions: Patient self-reported data registries are limited by patient perception or recall; however, these engaged and online MM pts may also be more biased toward knowing more about their medical history than the average pt. There are certainly real or perceived gaps in optimized genetic and imaging testing, which may reflect a communication or education gap. Pt reported interventions via an online portal can help investigators survey the pt community and result in hypothesis generating research questions including the actual use of testing, communication and education about testing and testing options, and MD trends in testing. [Table: see text][Table: see text]

e20567 Background: Multiple myeloma (MM) is a cancer of the immune system. Infection is a major cause of morbidity and mortality in MM. Vaccines are the first line of prevention for infectious diseases. Anti-microbial prophylaxis may improve patient (pt) outcomes, but real-world use has not been well characterized. In order to engage the pt community regarding vaccination we utilized HealthTree (www.healthtree.org). Methods: An investigator-submitted online survey asking about infection prophylaxis and vaccinations was fielded to 4,944 pts from May 10, 2019, to January 9, 2020. The HealthTree platform queries pts about sharing data for research purposes. De-identified responses were aggregated and reviewed. The study was determined to be exempt by the Western Institutional Review Board. Results: 458 MM pts participated in the surveys and were able to select more than one option with the total response indicated below. Abbreviated questions and simplified responses are noted in Table including: 1. Have you ever been vaccinated in the last 5 years with a pneumococcal vaccine (PV)? 2. In the last 3 flu seasons, have you received the influenza vaccine (FV)? 3. After you began myeloma treatment, did you ever receive the anti-Varicella Zoster Virus (VZV, shingles) vaccine? 4. Were you (or are you currently) treated with anti-viral prophylaxis? 5. Were you (or are you currently) treated with antibiotic bactrim? 6. Were you (or are you currently) treated with levofloxacin prior to stem cell transplant or at the beginning of your MM therapy? Conclusions: Both FV and PV were fairly high in this self-selected cohort of volunteers compared with a large health system ( http://ow.ly/O8Dx30b9Wuc ) and a global registry ( http://ow.ly/Uofg30h6Qen ). Most did not receive an anti-VZV vaccine, but a few received a live vaccine. Anti-viral prophylaxis was common, but not universal. Anti-PJP and levofloxacin use were reported by a minority of participants. Pt reported interventions via an online portal can help investigators survey the pt community and result in hypothesis generating research questions including investigating vaccine: types, dosing, sequencing, and use of anti-infective interventions. [Table: see text]

Primary liver cancer is the 3rd leading cause of cancer mortality worldwide. Eighty-five percent of liver cancers is comprised of hepatocellular carcinoma (HCC). Risk of developing HCC increases when patients have obesity related comorbidities, involving non-alcoholic steatohepatitis (NASH), hepatic inflammation, or lipid accumulation. Additionally, obesity is generally regarded as a prime risk factor for the development of obstructive sleep apnea (OSA), a repeated obstruction of the upper airway during sleep leading to oxygen deficiency (OD), which also increases the incidence of NASH. The connection of these morbidities presume that patients suffering from obesity induced OSA have an increased risk of developing HCC. To examine obesity and OSA's role in HCC we combined three generally accepted methods: A one-time injection of tumor initiator diethylnitrosamine followed by continuous administration of the promoter phenobarbital, a high fat diet, and a hypoxia chamber to house the mice for regulation of their oxygen intake, allowing us to mimic the OD seen in OSA. Utilizing these treatment methods and applying microCT imaging to non-invasively and repeatedly monitor the liver, we have been able to examine the effects of obesity and/or OD. Preliminary result indicate that a high fat diet results in obesity, lipidosis and liver damage. Interestingly, OD seems to inhibit obesity while still generating hepatic inflammation. Furthermore, we have observed that obesity and OD together cause severe damage to the liver, enhancing the risk of developing HCC. This study will be a significant preclinical step in distinguishing mechanisms that may explain obesities and OSA's combined consequence in HCC. Citation Format: Nathan W. Sweeney, Cecil J. Gomes, Sairam Pathasarthasy, Jesse D. Martinez. The consequence of obesity and obstructive sleep apnea in liver cancer. [abstract]. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2016 Apr 16-20; New Orleans, LA. Philadelphia (PA): AACR; Cancer Res 2016;76(14 Suppl):Abstract nr 4329.

Abstract 2129 Objectives: T cell lineage is an independent high risk factor in acute lymphoblastic leukemia (ALL). T-ALL requires high dose multi-agent chemotherapy, conferring many toxic side effects. T-ALL treatment therefore needs new, targeted agents that preserve or improve current treatment efficacy, yet cause fewer side effects than existing chemotherapeutic regimens. To identify such drugs, we pioneered an in vivo screen using transgenic zebrafish with T cell-specific green fluorescent protein (GFP) expression. We reasoned that immature T cells in 5-day-old zebrafish larvae are developmentally analogous to T-ALL lymphoblasts, and likely rely upon similar signaling pathways. Hence, compounds that specifically eliminate T cells in zebrafish larvae might likewise selectively target T-ALL cells. An added benefit of our in vivo screen is that drugs added to the water housing fish larvae must cross an epithelial barrier, can be metabolized by the liver, and can be renally cleared, characteristics not assessed in in vitro-based screening strategies. In addition, by using early larvae as our subjects, drugs lacking T cell specificity will likely impair normal development and/or survival, which we postulate is a predictor of unwanted toxicities. In these ways, our screen mimicked the scenario encountered in patients. Our use of the transgenic p56lck::EGFP zebrafish line facilitated rapid visual assessment of efficacy of a large number of compounds in 96-well format. Materials and Results: In a proof-of-principle experiment, we identified several known anti-T-ALL drugs, most prominently glucocorticoids, from the “Spectrum” library (MicroSource Discovery Systems, Inc., Gaylordsville, CT) of well-characterized compounds. We then screened 39,200 small molecules from the “ChemBridge DIVERSet” combinatorial chemistry library (ChemBridge Corp., San Diego, CA) for those active against zebrafish larval T cells. Of 20 novel “hits” identified, one compound, dubbed Lenaldekar (“LDK”), met additional prioritization criteria. LDK does not impair the cell cycle of developing zebrafish, is well tolerated and orally bioavailable with favorable pharmacokinetic properties in mice. In addition, pilot studies with LDK indicate it is efficacious in treating T-ALL in juvenile and adult fish from an established transgenic rag2::ER-human cMyc T-ALL model. LDK kills all of several murine T-lymphocytic malignancies, induces apoptosis in all human T-ALL lines tested, and shows some activity in human B-ALL lines. However, glioblastoma, colon carcinoma, melanoma, or immortalized human embryonic kidney cell lines are not affected by LDK, even at high concentration (up to 25μM). Using the recently established “phosflow” technique we measured phosphorylation status of key signaling proteins in permeabilized T- and B-ALL lines. Regardless of PTEN status, PDK1, AKT and mTOR downstream targets p4EBP1 and p70S6kinase were dephosphorylated by LDK treatment, as was the p65 subunit of NFκB on serine 529. Results were corroborated by conventional Western blots. However, phosphorylation of STAT3, STAT5, pERK1-2, and p38 were not affected by LDK. LDK's action is distinguished from other AKT/mTOR inhibitors by its lack of activity against AKT-dependent glioblastoma and melanoma cell lines, and its lack of effect on cell size. Finally, LDK decreased tumor burden of human T-ALL in murine xenografts. Conclusions: In view of its apparent lymphocyte selectivity, we posit that LDK modulates a pathway relatively unique to ALL (and immature lymphoblast) cells. This suggests that LDK can serve as a novel molecular tool for studies of normal and malignant lymphocyte biology. Moreover, with its favorable pharmacokinetics, apparent lack of toxicity, and in vivo efficacy in two vertebrate ALL models, LDK is an attractive molecule for development into a targeted treatment for ALL and perhaps other lymphocytic malignancies. Disclosures: No relevant conflicts of interest to declare.