Academic literature on the topic 'McMillen Inc'

Abstract Introduction: Before the emergence of new treatments, refractory immune thrombocytopenia (ITP) was defined as the failure to achieve a minimum response to splenectomy and the requirement of long-term treatments to reduce risk of significant bleeding events. These patients experience a significant morbidity and mortality rate (1). The first aim of this study was to describe the characteristics of patients with multirefractory ITP (multi-ref ITP) according to an updated definition, i.e., patients who failed to respond to splenectomy, monoclonal anti-CD20 antibodies (rituximab, RTX) and both thrombopoietin-receptor agonists (TPO-RAs), as well as to identify associated factors with this phenotype. The second aim was to examine the long-term outcome of these patients. Patients and Methods: We carried out a multicenter retrospective study in France. Inclusion criteria of patients with multi-ref ITP were failure to splenectomy, rituximab and the two marketed TPO-RAs, or presentation of an absolute contraindication to these treatments. Failure to treatment was defined according to standardized international criteria and bleeding score as described by Khellaf et al. Physicians were interviewed and patients' medical charts collected using the standardized form of the Referral Center for Adult ITP. In order to assess the variables associated with multirefractory occurrences, patients with multi-ref ITP were compared with non-multirefractory patients: for each case, 5 controls were randomly selected from the ITP clinical research database at Henri-Mondor Hospital, matched on the year of diagnosis. This database includes all ITP patients followed in the French national center for autoimmune cytopenias. Univariate and multivariate conditional logistic regression models were performed (backward procedure, α=5%). Results: Thirty-seven patients (12 men/25 women) with multi-ref ITP and 183 controls were included in the study. Patients with multi-ref ITP have presented more initial bleeding symptoms than controls (75.6% vs 52.75%, p=.012)), had more frequently secondary ITP (35% vs 8.74%, p<.001), presented more clinical/biological auto-immune abnormalities (59.46% vs 28.42%, p=0008) and had more frequently a monoclonal gammopathy of undetermined significance than controls (19% vs 2.89%, p<.001). Only 24 patients with multi-ref ITP (68.57%) achieved initial transient response to steroid therapy (CR: n=10, R: n=12), compared to 91.61% responders in controls (p<.0001). In multivariate analysis, 4 factors were found to be associated with multi-ref ITP occurrence: (1) secondary ITP (OR: 4.81, 95%CI [1.31-17.86], p=.018), (2) presence of monoclonal gammopathy (OR: 5.93, 95%CI [1.08-32.48], p<.04), (3) bleeding symptoms at diagnosis (OR: 3.54 95%CI [1.11-11.22], p=.032) and (4) no response to steroid therapy (OR: 0.38 95%CI [0.20-0.72], p= .003). After a median follow-up of 84 months (range: 12-455), patients with multi-ref ITP have received a median of 10.5 lines of treatments (range: 6-15) including splenectomy, TPO-RAs and RTX, 5 patients (14%) died (intracranial hemorrhage, n=2; sepsis, n=1; breast cancer, n=1; unknown, n=1). Throughout the course of ITP, all patients required hospitalization; 22 (60%) received platelet transfusion, and 6 red-blood cells transfusion, 9 (24%) were admitted to intensive care units, 15 (40%) presented at least one bacterial infection, and 9 experienced at least one thrombosis (arterial, n=3; venous, n=6). At the end of follow-up, 20 patients (54%) were still non responders. Nine patients achieved a complete response: one after autologous hematopoietic stem cell transplantation, 2 after chemotherapy for hematological malignancy, and 5 after a combination of immunosuppressive therapy and TPO-RA. Conclusion: Our study demonstrated that multirefractory ITP is an extremely serious condition, associated with a high morbidity and mortality. Factors significantly associated with this phenotype were secondary ITP, association with autoimmune disorders, monoclonal gammopathy and no response to steroids. Most of these patients remained non-responsive to alternative lines of rescue treatment, but some successes has been obtained with the combination of immunosuppressive therapy and TPO-RA. (1) McMillan R, Durette C. Long-term outcomes in adults with chronic ITP after splenectomy failure. Blood 2004;104(4):956-60 Disclosures Salles: Calistoga Pharmaceuticals, Inc.; Celgene Corporation; Genentech, Inc.; Janssen Pharmaceutica Products, L.P.; Roche: Consultancy; Celgene Corporation; Roche and Gilead Sciences: Research Funding; Celgene Corporation; Roche: Speakers Bureau. Cheze:Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees. Michel:GSK: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Roche: Research Funding; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; AMGEN: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Godeau:Roche: Research Funding; Amgen: Speakers Bureau; Novartis: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

Abstract Abstract 1373 The aim of this work was to establish a robust and simple method for the measurement of drug sensitivity in myeloma cells under conditions mimicking aspects of the bone marrow microenvironment. In particular we wanted to measure drug sensitivity in myeloma cells cultivated in the presence of stromal cells. The tumor microenvironment can profoundly affect tumor cell survival as well as alter antitumor drug activity, and it is generally believed that growth and survival of myeloma cells is critically dependent on the bone marrow microenvironment. Bone marrow stromal cells (BMSC) have been shown to protect myeloma cells from common cytostatic or cytotoxic drugs in vitro. Common in vitro assays used for high-throughput drug screening cannot easily discriminate between stromal and tumor cell responses in co-cultures. Although a few recent studies have overcome this problem (Ramasamy K. et al., 157(5):564–79,2012, McMillin D. et al., 16(4):483–9, 2010), the application of stable transfection for labeling of cells limits the practical application of these co-culture studies to cell lines, excluding primary myeloma cells that inherently may be hard to transduce even by retroviral vectors. Here, we analyzed survival of myeloma cells co-cultured with BMSC using an automated fluorescence microscope, ScanR. ScanR is a microscope based screening station. By staining the cell nuclei with DRAQ5, we were able to discriminate between BMSC and myeloma cells, based on their staining intensity and nuclear shape. Using the apoptotic marker YO-PRO-1, the effects of drug treatment on the viability of the myeloma cells in the presence of stromal cells could be measured. The main advantages of this method are the non-necessity of cell manipulation before co-culture and the low number of myeloma cells (5000 primary cells) that are needed per measurement, which makes the method ideal for experiments with primary myeloma cells. In fact, the analysis was easier and more robust when using slowly growing cells, i.e. by using primary myeloma cells compared to more rapidly proliferating myeloma cell lines. This method should be well-suited for high throughput analysis, as the cells are stained in situ with no washing, centrifugation, or fixation steps before analysis. The method was compared to a conventional method for detecting cell viability; flow cytometry where annexin V labeling was used to detect apoptotic cells. As shown in figure 1, the dose-response curves obtained for ANBL-6 cells treated with different doses of melphalan were similar and showed the same trends for both methods. However, the effects of melphalan treatment were more evident analyzed by the ScanR system than by flow cytometry (EC50 YO-PRO-1 = 11μM versus EC50Annexin V= 15μM). The stromal cell population applied in this study was able to support IL-6 dependent myeloma cell lines without addition of IL-6. This as IL-6 dependent INA-6 cells cultivated in the presence of BMSC survived in the absence of added IL-6. This study shows the importance of stromal cell support for primary myeloma cell survival in vitro, as half of the cell samples had a marked increase in their viability when cultured in the presence of BMSC. Stromal cell-induced protection against common myeloma drugs was also observed with this method. For instance, experiments with primary myeloma cells from patient MM7, showed that in the presence of BMSC, the EC50 for the common myeloma drug cyclophosphamide was increased from 5 μM to approximately 10 μM (figure 2). Figure 1 Figure 1. Figure 2 Figure 2. Disclosures: No relevant conflicts of interest to declare.

Abstract Abstract 2923 Midostaurin (PKC412; Novartis Pharmaceuticals) is a multi-targeted kinase inhibitor currently being evaluated in clinical trials in acute myelogenous leukemia (AML), because of its potent activity in cells expressing mutant FLT3. Prior preclinical studies from our groups have shown that PKC412 has FLT3-independent anti-MM activity, and the effects on AML cells is suppressed by the presence of conditioned media from bone marrow stromal cells (BMSCs), such as the immortalized BMSC line HS-5 (Weisberg et al. Mol Cancer Ther 2007). In this study, we evaluated whether the microenvironment-dependent drug resistance to PKC412 applies to not only AML cells, but also to cells from MM and other FLT3-negative malignant cells. We tested a panel of cells from MM (n=8), FLT-ITDneg AML (n=1), CML (n=2) and breast cancer (n=2) for their response to PKC412 in the presence or absence of BMSCs and other non-malignant accessory cells using tumor cell compartment-specific bioluminescence imaging (CS-BLI), as in our antecedent studies (McMillin et al. Nat Medicine 2010). We also compared the PKC412 response of the aforementioned neoplastic cells when cultured in vitro in the presence or absence of conditioned media (CM) from different types of BMSCs known to confer PKC412 resistance in FLT3-mutant AML cells. Consistent with our previous studies of PKC412 treatment in conventional cultures of MM cells in isolation, we observed that PKC412 exhibits an anti-proliferative effect within the first 24 hrs of treatment, with major reduction of the numbers of viable cells at 48 and 72 hrs. At sub-micromolar doses that did not significantly affect the viability of non-malignant accessory cells tested, PKC412 had similar (or for some MM cell lines had more pronounced) activity against the MM cells, both in the presence and absence of the non-malignant accessory cells tested (HS-5, HS-27a, NIH-3T3 cells with or without transfection with human CD40L, etc.). In contrast, under the same experimental conditions, coculture with either BMSCs or exposure to their conditional media, decreased the response of MM cells to dexamethasone. These results suggested in contrast to the impact on FLT3mut AML, that the anti-MM activity of PKC412 is preserved (and in some cases slightly enhanced) when the MM cells interact with microenvironmental accessory cells and/or their secreted growth/survival factors. To obtain insight on possible mechanistic foundations of these observations, we examined the pattern of kinases inhibited by PKC412 at sub-μM concentrations (using FLT3 and FGFR3, known targets of PKC412 as positive controls). The results of in vitro kinase activity assays showed that PKC412 potently suppresses the aforementioned positive controls, but also exerts >50% inhibitory effect on the in vitro activity of additional kinases such as Akt2, Pim1, GSK3a, PDK1, p70S6K, SRC and Aurora A. Many of these kinases are known to participate in proliferative/anti-apoptotic signaling cascades downstream of cytokine/growth factor receptors or cell adhesion-mediated events triggered during MM–stromal interactions. We therefore conclude that the influence of the tumor microenvironment on the anti-neoplastic effects of PKC412 may be tumor-type dependent. The anti-MM activity of PKC412 is not subject to drug resistance triggered by non-malignant accessory cells, and conversely is occasionally moderately enhanced by these MM-stromal interactions. Mechanistically, this observation may be attributed in part to the multi-targeted nature of this inhibitor and, in particular, its aggregate impact on several kinases known to mediate stroma-induced proliferative and antipoptotic signaling in MM. Disclosures: Griffin: Novartis Pharmaceuticals: Consultancy, Research Funding. Richardson:Millennium: ; Celgene: ; Johnson & Johnson: ; Novartis: ; Bristol Myers Squibb:. Anderson:Celgene: Consultancy, Honoraria; Millennium Pharmaceuticals, Inc.: Consultancy, Honoraria; Novartis: Consultancy, Honoraria. Mitsiades:EMD Serono: Research Funding; AVEO Pharma: Research Funding; Amgen: Research Funding; OSI Pharmaceuticals: Research Funding; PharmaMar: licensing royalties; Amnis Therapeutics: Consultancy, Honoraria; Centocor: Consultancy, Honoraria; Pharmion: Consultancy, Honoraria; Kosan: Consultancy, Honoraria; Merck: Consultancy, Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria; Novartis Pharmaceuticals: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Millennium Pharmaceuticals: Consultancy, Honoraria; Sunesis: Research Funding; Gloucester Pharmaceuticals: Research Funding; Genzyme: Research Funding; Johnson & Johnson: Research Funding.

Introduction: The antibody-drug conjugate polatuzumab vedotin (pola) targets CD79b on B-cell malignancies. Pola in combination with bendamustine and rituximab (BR) improved complete response (CR) rate and overall survival (OS) in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), compared with BR alone (CR rate: 40% vs 18%, respectively, p=0.026; median OS: 12.4 vs 4.7 months, respectively, p=0.0023; Sehn et al. ASH 2018). Based on these results, pola + BR was recently approved by the FDA for patients with R/R DLBCL after at least two prior therapies. NCCN guidelines (2019) suggest multiple second-line and subsequent treatment options for patients with R/R DLBCL; in practice, a wide range of options are used (Herrera et al. Hematol Oncol 2019). One recommended option is rituximab plus gemcitabine and oxaliplatin (R-GemOx; Mounier et al. Haematol 2013; Cazelles et al. Hematol Oncol 2019). Platinum-based chemotherapies such as oxaliplatin are a preferred salvage approach for patients with R/R DLBCL (Tilly et al. Ann Oncol 2015). The safety of pola combined with platinum-based therapies in R/R DLBCL has not yet been assessed, and both pola and platinum-based therapies are associated with neuropathy. In the POLARGO study, we will assess the safety and efficacy of pola in combination with R-GemOx, compared with R-GemOx alone, in patients with R/R DLBCL. Methods: POLARGO (MO40598) is a multicenter, open-label, Phase III study, comprising two stages: 1) a safety run-in stage evaluating pola + R-GemOx in 10 patients and 2) a randomized controlled trial (RCT) stage comparing pola + R-GemOx with R-GemOx alone in an expected 206 patients. In the RCT stage, patients will be recruited from 80─90 sites globally. Patients must have histologically confirmed R/R DLBCL, confirmed availability of archival or freshly collected tumor tissue (RCT stage), and ECOG performance status of 0-2. Relapse is defined as disease that recurs following a response lasting ≥ 6 months from completion of the last line of therapy. Refractory is defined as disease that progressed during previous therapy or stable disease for up to 6 months from completion of the last line of therapy. Patients will be excluded if they have had allogeneic stem-cell transplantation (SCT) and/or have planned autologous/allogeneic SCT. Patients with baseline peripheral neuropathy greater than grade 1 (as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 [NCI CTCAE v5.0]) will be excluded. The primary endpoint of the safety run-in stage is the safety and tolerability of pola (1.8mg/kg) + R-GemOx (R, 375mg/m2; Gem, 1000mg/m2; Ox, 100mg/m2) administered in 21-day cycles, as assessed by the incidence, nature, and severity of adverse events (AEs; NCI CTCAE v5.0), with a focus on peripheral neuropathy. If pola + R-GemOx is tolerable in the safety run-in stage, new patients will be enrolled in the RCT stage. At randomization, patients will be stratified by number of previous lines of systemic therapy for DLBCL, outcome of last systemic therapy (relapsed vs refractory), and age (≤70 years vs >70 years). Patients will be randomized (1:1) to receive up to eight 21-day cycles of either pola + R-GemOx or R-GemOx alone. The primary endpoint of the RCT stage is OS, defined as the time from randomization to death from any cause. The secondary efficacy endpoints are: best overall response, progression-free survival, duration of objective response, event-free survival, CR rate and objective response rate (according to Lugano 2014 criteria), as determined by the investigator and an independent review committee. Safety will be assessed by recording the incidence, nature, and severity of AEs (NCI CTCAE v5.0), with a focus on peripheral neuropathy. Dose interruptions, reductions, and intensity will be used to determine tolerability. The impact of treatment on health-related quality of life will be assessed. PET-CT and CT scans will be obtained at screening, during, and after the treatment period; 28 days after the last dose of study drug; and then every two (PET-CT), and six (CT) months during follow-up for up to 2 years. Disclosures McMillan: Sandoz: Honoraria; Novartis: Honoraria; Celgene: Honoraria, Speakers Bureau; Gilead: Honoraria; Pfizer: Honoraria, Research Funding; MSD: Honoraria; F. Hoffmann-La Roche Ltd: Honoraria, Speakers Bureau; BMS: Honoraria. Matasar:Bayer: Other: Travel, accommodation, expenses; Janssen: Honoraria, Research Funding; Pharmacyclics: Consultancy, Honoraria, Research Funding; GlaxoSmithKline: Honoraria, Research Funding; Daiichi Sankyo: Consultancy; Seattle Genetics: Consultancy, Honoraria, Other: Travel, accomodation, expenses, Research Funding; Rocket Medical: Consultancy, Research Funding; Genentech, Inc.: Consultancy, Honoraria, Other: Travel, accommodation, expenses , Research Funding; Bayer: Consultancy, Honoraria, Other; Roche: Consultancy, Honoraria, Other: Travel, accommodation, expenses , Research Funding; Merck: Consultancy, Equity Ownership; Juno Therapeutics: Consultancy; Teva: Consultancy. Sancho:Sandoz: Consultancy; F. Hoffmann-La Roche Ltd: Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Honoraria; Celltrion: Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squib: Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead: Consultancy, Honoraria, Other: Advisory board; Novartis: Honoraria; Kern Pharma: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Viardot:Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria; Kite/Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees; F. Hoffmann-La Roche Ltd: Honoraria, Membership on an entity's Board of Directors or advisory committees. Hernandez:F. Hoffmann-La Roche Ltd: Employment. Perretti:F. Hoffmann-La Roche Ltd: Employment. Haioun:Servier: Honoraria; Miltenyi: Honoraria; Takeda: Honoraria; F. Hoffmann-La Roche Ltd: Honoraria; Gilead: Honoraria; Amgen: Honoraria; Celgene: Honoraria; Novartis: Honoraria; Janssen: Honoraria. OffLabel Disclosure: Polatuzumab vedotin (POLIVY, Genentech, Inc.) is a CD79b-directed antibody-drug conjugate. It was approved by the FDA in June 2019 in combination with bendamustine and rituximab for the treatment of adults with relapsed/refractory diffuse large B-cell lymphoma after at least two prior therapies.

To improve online learning pedagogy within the field of paralegal education, this study investigated how paralegal students and paralegal instructors perceived the effectiveness of synchronous and asynchronous online paralegal courses. This study intended to inform paralegal instructors and course developers how to better design, deliver, and evaluate effective online course instruction in the field of paralegal studies.Survey results were analyzed using independent samples t-test and correlational analysis, and indicated that overall, paralegal students and paralegal instructors positively perceived synchronous and asynchronous online paralegal courses. Paralegal instructors reported statistically significant higher perceptions than paralegal students: (1) of instructional design and course content in synchronous online paralegal courses; and (2) of technical assistance, communication, and course content in asynchronous online paralegal courses. Instructors also reported higher perceptions of the effectiveness of universal design, online instructional design, and course content in synchronous online paralegal courses than in asynchronous online paralegal courses. Paralegal students reported higher perceptions of asynchronous online paralegal course effectiveness regarding universal design than paralegal instructors. No statistically significant differences existed between paralegal students’ perceptions of the effectiveness of synchronous and asynchronous online paralegal courses. A strong, negative relationship existed between paralegal students’ age and their perceptions of effective synchronous paralegal courses, which were statistically and practically significant. Lastly, this study provided practical applicability and opportunities for future research. Akyol, Z., & Garrison, D. R. (2008). 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In Veil and Vow, Aneeka Ayanna Henderson places familiar, often politicized questions about the crisis of African American marriage in conversation with a rich cultural archive that includes fiction by Terry McMillan and Sister Souljah, music by Anita Baker, and films such as The Best Man. Seeking to move beyond simple assessments of marriage as "good" or "bad" for African Americans, Henderson critically examines popular and influential late twentieth- and early twenty-first-century texts alongside legislation such as the 1996 Defense of Marriage Act and the Welfare Reform Act, which masked true sources of inequality with crisis-laden myths about African American family formation. Using an interdisciplinary approach to highlight the influence of law, politics, and culture on marriage representations and practices, Henderson reveals how their kinship veils and unveils the fiction in political policy as well as the complicated political stakes of fictional and cultural texts. Providing a new opportunity to grapple with old questions, including who can be a citizen, a "wife," and "marriageable," Veil and Vow makes clear just how deeply marriage still matters in African American culture.

Examines the ways that growing up in a supportive, ambitious community spurred Charlotte's young African Americans to question and then challenge inequality.Highlights key moments in Charlotte's civil rights history, including the furor sparked by Dorothy Counts' efforts to become the first black student at Harding High School in 1957, the sit-ins of 1960, the successful efforts to desegregate restaurants in 1963, and the bombs that exploded at the homes of four civil rights activist families in 1965. Follows Swann v. Charlotte-Mecklenburg, the landmark desegregation case filed by civil rights attorney Julius Chambers. In 1969, Chambers convinced federal judge James McMillan to issue a sweeping order that required Charlotte-Mecklenburg to fully desegregate every school in the countywide system, setting the stage for the nation's most comprehensive school busing plan.

This chapter analyses the dissemination of socialist aesthetics in the press up until 1914. During the 1890s, the rise of the ILP shifted the locus of such debates from London to northern manufacturing towns, as is evident from the contributions of Isabella Ford, Margaret McMillan, Robert Blatchford, and Alfred Orage to the Clarion, Labour Leaden and the Leeds Arts Club. The discussion focuses on the development of Orage's politics and aesthetics from his early work with Isabella Ford and Edward Carpenter in Leeds to the peak of his influence as editor of the New Age in 1914. Orage came to reject both the ‘sentimental’ aesthetics of the ILP and the compromises of the Parliamentary Labour Party in the early twentieth century; turning instead to the model of guild socialism.