Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: subgroup analysis of CASTOR based on cytogenetic risk

BACKGROUND: Multiple myeloma (MM) patients with high cytogenetic risk have poor outcomes. In CASTOR, daratumumab plus bortezomib/dexamethasone (D-Vd) prolonged progression-free survival (PFS) versus bortezomib/dexamethasone (Vd) alone and exhibited tolerability in patients with relapsed or refractory MM (RRMM). METHODS: This subgroup analysis evaluated D-Vd versus Vd in CASTOR based on cytogenetic risk, determined using fluorescence in situ hybridization and/or karyotype testing performed locally. High-risk patients had t(4;14), t(14;16), and/or del17p abnormalities. Minimal residual disease (MRD; 10-5 sensitivity threshold) was assessed via the clonoSEQ\uae assay V2.0. Of the 498 patients randomized, 40 (16%) in the D-Vd group and 35 (14%) in the Vd group were categorized as high risk. RESULTS: After a median follow-up of 40.0\u2009months, D-Vd prolonged median PFS versus Vd in patients with standard (16.6 vs 6.6\u2009months; HR, 0.26; 95% CI, 0.19-0.37; P < 0.0001) and high (12.6 vs 6.2\u2009months; HR, 0.41; 95% CI, 0.21-0.83; P = 0.0106) cytogenetic risk. D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk. The safety profile was consistent with the overall population of CASTOR. CONCLUSION: These updated data reinforce the effectiveness and tolerability of daratumumab-based regimens for RRMM, regardless of cytogenetic risk status. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02136134 . Registered 12 May 2014

PF596 EFFICACY AND SAFETY OF DARATUMUMAB, BORTEZOMIB, AND DEXAMETHASONE (D-VD) IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM): UPDATED SUBGROUP ANALYSIS OF CASTOR BASED ON CYTOGENETIC RISK

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Daratumumab plus bortezomib and dexamethasone versus bortezomib and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of CASTOR

Daratumumab, a CD38 human monoclonal antibody, demonstrated significant clinical activity in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone alone in the primary analysis of CASTOR, a phase 3 study in relapsed and/or refractory multiple myeloma. A post hoc analysis based on treatment history and longer follow-up is presented. After 19.4 (range: 0 to 27.7) months of median follow-up, daratumumab plus bortezomib and dexamethasone prolonged progression-free survival (median: 16.7 versus 7.1 months; hazard ratio, 0.31; 95% confidence interval, 0.24-0.39; P 12, 646, or >6 months), or cytogenetic risk. Minimal residual disease-negative rates were >2.5-fold higher with daratumumab across subgroups. The safety profile of daratumumab plus bortezomib and dexamethasone remained consistent with longer follow-up. Daratumumab plus bortezomib and dexamethasone demonstrated significant clinical activity across clinically relevant subgroups and provided the greatest benefit to patients treated at first relapse

Beyond the Classroom: Implementing Academic Service-Learning

Businesses struggle with complicated issues that were not discussed and/or did not exist 25 years ago, and “higher education has not adequately responded to the need to prepare students for this complex environment” (Dallimore, 2002:86). Experiential teaching methods, including academic service-learning, address some of these challenges in higher education. The purpose of this paper is to assist management educators and practitioners in understanding the academic service-learning pedagogy and its worth and applicability to management education

Academic Service-Learning in the Human Resource Development Curriculum

Academic service-learning is a relatively new pedagogy that uses service activities to support traditional teaching methods, giving students a better understanding and ability to remember and carry out functions/skills taught in class. Although its use in human resource development courses has rarely been reported in the literature, preliminary research appears to suggest that academic service-learning would be an ideal teaching method for instilling in students the skills and/or traits necessary to be successful in human resource development (e.g., intellectual versatility, adult learning insight, and industry understanding)

Teaching Citizenship Through Service-Learning

Academic service-learning has been described as a way to respond to the continual concerns regarding the loss of a sense of community in this country. This paper will discuss this pedagogy and present the results of a qualitative research study that explored the citizenship-related perceptions, experiences, and reflections of students who participated in a service-learning project for a business management course in 2003 and 2004. The paper will also provide implications for faculty interested in facilitating learning through this teaching methodology

Academic Service Learning Experiences of Compensation and Benefit Course Students

The purpose of this phenomenological study was to explore the perceptions and experiences of human resource students who had recently and successfully completed a service learning project for an undergraduate compensation and benefits course. Four specific themes or categories emerged from the 10 in-depth student interviews: pedagogical differences, student learning, personal benefits, and challenges and problems. Findings support the premise that academic service learning in human resource coursework is effective and beneficial for students. In fact, all felt that they learned and benefited more from this project or assignment than from any other they had undertaken

Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: Subgroup analysis of CASTOR based on cytogenetic risk

Background: Multiple myeloma (MM) patients with high cytogenetic risk have poor outcomes. In CASTOR, daratumumab plus bortezomib/dexamethasone (D-Vd) prolonged progression-free survival (PFS) versus bortezomib/dexamethasone (Vd) alone and exhibited tolerability in patients with relapsed or refractory MM (RRMM). Methods: This subgroup analysis evaluated D-Vd versus Vd in CASTOR based on cytogenetic risk, determined using fluorescence in situ hybridization and/or karyotype testing performed locally. High-risk patients had t(4;14), t(14;16), and/or del17p abnormalities. Minimal residual disease (MRD; 10-5 sensitivity threshold) was assessed via the clonoSEQ\uae assay V2.0. Of the 498 patients randomized, 40 (16%) in the D-Vd group and 35 (14%) in the Vd group were categorized as high risk. Results: After a median follow-up of 40.0 months, D-Vd prolonged median PFS versus Vd in patients with standard (16.6 vs 6.6 months; HR, 0.26; 95% CI, 0.19-0.37; P < 0.0001) and high (12.6 vs 6.2 months; HR, 0.41; 95% CI, 0.21-0.83; P = 0.0106) cytogenetic risk. D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk. The safety profile was consistent with the overall population of CASTOR. Conclusion: These updated data reinforce the effectiveness and tolerability of daratumumab-based regimens for RRMM, regardless of cytogenetic risk status. Trial registration: ClinicalTrials.gov, NCT02136134. Registered 12 May 201