Clinical characteristics and outcomes in risk-stratified patients with smoldering multiple myeloma: data from the Czech Republic Registry of Monoclonal Gammopathies.

Smoldering multiple myeloma (SMM) is an asymptomatic precursor to active multiple myeloma (MM). The aim of this study was to report clinical characteristics and outcomes of patients with SMM stratified based on their risk of progression to MM using the Mayo 20/2/20 criteria. Data were leveraged from the Czech Myeloma Group Registry of Monoclonal Gammopathies (RMG). Key outcomes included progression-free survival from SMM diagnosis to active MM diagnosis or death (PFS), progression-free survival from SMM diagnosis to progression on first line (1 L) MM treatment or death (PFS2), and overall survival (OS). Of 498 patients, 174 (34.9%) were classified as high risk and 324 (65.1%) as non-high risk. Median follow-up was approximately 65 months. During follow-up, more patients in the high-risk vs non-high-risk group received 1 L MM treatment (76.4% vs 46.6%, p < 0.001). PFS, PFS2, and OS were significantly shorter in high-risk vs non-high-risk patients (13.2 vs 56.6 months, p < 0.001; 49.9 vs 84.9 months, p < 0.001; 93.2 vs 131.1 months, p = 0.012, respectively). The results of this study add to the growing body of evidence that patients with high-risk vs non-high-risk SMM have significantly worse outcomes, including OS.

Indirect Treatment Comparison of Daratumumab, Pomalidomide, and Dexamethasone Versus Standard of Care in Patients with Difficult-to-Treat Relapsed/Refractory Multiple Myeloma.

INTRODUCTION: The phase 3 APOLLO study demonstrated significantly better progression-free survival (PFS) and clinical responses with daratumumab, pomalidomide, and dexamethasone (D-Pd) versus pomalidomide and dexamethasone (Pd) in patients with relapsed/refractory multiple myeloma (RRMM). On the basis of these results and those from the phase 1b EQUULEUS trial, D-Pd was approved in this patient population. In the absence of head-to-head data comparing D-Pd with further standard of care (SOC) therapies, indirect treatment comparisons (ITCs) can provide important information to help optimize treatment selection. The objective of this study was to indirectly compare PFS improvement with D-Pd versus daratumumab, bortezomib, and dexamethasone (D-Vd) and D-Pd versus bortezomib and dexamethasone (Vd) in patients with RRMM. METHODS: Patient-level data were from APOLLO, EQUULEUS, and CASTOR. Three methods of adjusting imbalances in baseline characteristics including stabilized inverse probability of treatment weighting (sIPTW), cardinality matching (CM), and propensity score matching (PSM) were initially considered. CM offers mathematically guaranteed largest matched sample meeting pre-specified maximum standardized mean difference criteria for matching covariates. sIPTW and PSM were based on propensity scores derived from logistic regression. Feasibility assessment of the PSM method returned too low effective sample size to support a meaningful comparison. CM was chosen as the base case and sIPTW as a sensitivity analysis. RESULTS: After harmonized eligibility criteria were applied, 253, 104, and 122 patients from the D-Pd, D-Vd, and Vd cohorts, respectively, were included in the ITC analyses. Some imbalances in baseline characteristics were identified between D-Pd and D-Vd/Vd cohorts that remained after adjustment. PFS hazard ratios showed significant improvement for D-Pd over D-Vd and Vd for CM and sIPTW analyses. CONCLUSIONS: Results showed consistent PFS benefit for D-Pd versus D-Vd and Vd regardless of the adjustment technique used. These findings support the use of D-Pd versus D-Vd or Vd in patients with difficult-to-treat RRMM. TRIAL REGISTRATION: NCT03180736; NCT02136134, NCT01998971.

Balance of academic responsibilities of clinical track pharmacy faculty in the United States: a survey of select American College of Clinical Pharmacy Practice and Research Network Members.

STUDY OBJECTIVES: To characterize the balance of clinical and academic responsibilities of clinical track pharmacy faculty in the United States and evaluate organizational structures that promote satisfactory balance between these responsibilities. DESIGN: Prospective cross-sectional survey. SETTING: A 22-item online survey was developed and distributed via Qualtrics software. PARTICIPANTS: Clinical faculty members of the American College of Clinical Pharmacy Adult Medicine, Ambulatory Care, Cardiology, Critical Care, Gastrointestinal/Liver/Nutrition, Immunology/Transplantation, Infectious Disease, and Pediatrics Practice and Research Networks (PRNs) were invited to participate via the PRN electronic mailing list. MEASUREMENTS AND MAIN RESULTS: The survey comprised questions related to demographics, organizational structure, and balance of clinical and academic responsibilities. A total of 344 participants responded to some or all of the survey questions. The demographics were relatively equally balanced between faculty at state and private academic institutions, academic rank, and practice setting. Expected and actual effort allocations were similar for each of the clinical and academic responsibilities, with direct patient care and clinical teaching representing more than 50% effort allocation cumulatively. Clinical faculty at state institutions devoted a larger proportion of time to clinical service, whereas clinical faculty at private institutions devoted a greater proportion of time to didactic teaching. When asked about time constraints, 157 (69.8%) of the 225 survey participants responding to this question did not believe they had sufficient time to fulfill their nonclinical academic needs. Clinical faculty who were provided "protected time" away from clinical service had a significantly more favorable opinion of this question. CONCLUSION: Most of the clinical track pharmacy faculty indicated that they have insufficient time to fulfill their nonclinical academic responsibilities. Provision of protected time may alleviate some of these time constraints.

Anticoagulation patient self-monitoring in the United States: considerations for clinical practice adoption.

Systematic management models such as anticoagulation clinics have emerged in order to optimize warfarin effectiveness and to minimize related complications. Most of these models are structured so that patients come to a clinic for in-person testing and evaluation, thus making this model of care difficult to access and time consuming for many patients. The emergence of portable instruments for measuring anticoagulant effect in capillary whole blood made it possible for patients receiving warfarin to self-monitor the effect of their anticoagulant therapy. Self-monitoring empowers patients, offers the advantage of more frequent monitoring, and increases patient convenience by allowing testing at home and avoiding the need for frequent laboratory and clinic visits. Self-monitoring can entail patient self-testing (PST) and/or patient self-management (PSM). Several studies have evaluated and shown the benefit of both PST and PSM models of care when compared with either routine medical care or anticoagulation clinic management of anticoagulation therapy. Self-monitoring (PSM and/or PST) of anticoagulation results in lower thromboembolic events, lower mortality, and no increase in major bleeding when compared with standard care. Despite favorable results and enhanced patient convenience, the adoption of self-monitoring into clinical practice in the United States has been limited, especially in higher risk, disadvantaged populations. Although the emergence of a multitude of novel oral anticoagulants will permit clinicians to better individualize anticoagulant therapy options by choosing the optimum regimen based on individual patient characteristics, it is also expected that traditional agents will continue to play a role in a significant subset of patients. For those patients treated with traditional anticoagulants such as warfarin, future models of care will entail patient-centered management such as PST and PSM. The incorporation of technology (i.e., Web-based expert systems) is expected to further improve the outcomes realized by PST and PSM. Further studies are needed to explore factors that influence the adoption of self-monitoring in the United States and to evaluate the feasibility and implementation in real-life clinical settings.