RESUMO
BACKGROUND: Belantamab mafodotin had single-agent activity in patients with relapsed or refractory multiple myeloma, a finding that supports further evaluation of the agent in combination with standard-care therapies. METHODS: In this phase 3, open-label, randomized trial, we evaluated belantamab mafodotin, bortezomib, and dexamethasone (BVd), as compared with daratumumab, bortezomib, and dexamethasone (DVd), in patients who had progression of multiple myeloma after at least one line of therapy. The primary end point was progression-free survival. Key secondary end points were overall survival, response duration, and minimal residual disease (MRD)-negative status. RESULTS: In total, 494 patients were randomly assigned to receive BVd (243 patients) or DVd (251 patients). At a median follow-up of 28.2 months (range, 0.1 to 40.0), median progression-free survival was 36.6 months (95% confidence interval [CI], 28.4 to not reached) in the BVd group and 13.4 months (95% CI, 11.1 to 17.5) in the DVd group (hazard ratio for disease progression or death, 0.41; 95% CI, 0.31 to 0.53; P<0.001). Overall survival at 18 months was 84% in the BVd group and 73% in the DVd group. An analysis of the restricted mean response duration favored BVd over DVd (P<0.001). A complete response or better plus MRD-negative status occurred in 25% of the patients in the BVd group and 10% of those in the DVd group. Grade 3 or higher adverse events occurred in 95% of the patients in the BVd group and 78% of those in the DVd group. Ocular events were more common in the BVd group than in the DVd group (79% vs. 29%); such events were managed with dose modifications, and events of worsening visual acuity mostly resolved. CONCLUSIONS: As compared with DVd therapy, BVd therapy conferred a significant benefit with respect to progression-free survival among patients who had relapsed or refractory multiple myeloma after at least one line of therapy. Most patients had grade 3 or higher adverse events. (Funded by GSK; DREAMM-7 ClinicalTrials.gov number, NCT04246047; EudraCT number, 2018-003993-29.).
RESUMO
BACKGROUND: Social distancing guidelines for COVID-19 have caused a rapid transition to telephone and video technologies for delivering treatment for substance use disorders (SUDs). OBJECTIVE: This study examined the adoption of these technologies across the SUD service continuum, acceptance of these technologies among service providers, and intent of providers to use these technologies after the pandemic. Additional analysis using the validated technology acceptance model (TAM) was performed to test the potential applications of these technologies after the pandemic. The study objectives were as follows: (1) to assess the use of telehealth (telephone and video technologies) for different SUD services during COVID-19 in May-June 2020, (2) to assess the intended applications of telehealth for SUD services beyond COVID-19, (3) to evaluate the perceived ease of use and value of telehealth for delivering SUD services, and (4) to assess organizational readiness for the sustained use of telehealth services. METHODS: An online survey on the use of telephonic and video services was distributed between May and August 2020 to measure the current use of these services, perceived organizational readiness to use these services, and the intent to use these services after COVID-19. In total, 8 of 10 regional Addiction Technology Transfer Centers representing 43 states distributed the survey. Individual organizations were the unit of analysis. RESULTS: In total, 457 organizations responded to the survey. Overall, the technology was widely used; >70% (n>335) of organizations reported using telephone or video platforms for most services. The odds of the intent of organizations to use these technologies to deliver services post COVID-19 were significantly greater for all but two services (ie, telephonic residential counseling and buprenorphine therapy; mean odds ratio 3.79, range 1.87-6.98). Clinical users preferred video technologies to telephone technologies for virtually all services. Readiness to use telephone and video technologies was high across numerous factors, though telephonic services were considered more accessible. Consistent with the TAM, perceived usefulness and ease of use influenced the intent to use both telephone and video technologies. CONCLUSIONS: The overall perceived ease of use and usefulness of telephonic and video services suggest promising post-COVID-19 applications of these services. Survey participants consistently preferred video services to telephonic services; however, the availability of telephonic services to those lacking easy access to video technology is an important characteristic of these services. Future studies should review the acceptance of telehealth services and their comparative impact on SUD care outcomes.