Meeting Highlights:
Safety and efficacy of ciltacabtagene autoleucel for relapsed/refractory multiple myeloma: a CIBMTR study.
In this study, researchers evaluated the safety and efficacy of ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen (BCMA)–targeting chimeric antigen receptor T-cell (CAR-T) therapy, as standard of care (SOC) for the treatment of relapsed/refractory multiple myeloma (RRMM). A total of 595 patients in the Center for International Blood and Marrow Transplant Research (CIBMTR) registry who received cilta-cel between April 2022 and December 2023 were included for analysis. Median age was 64 years, and most patients were male (57%) and had one or more clinically significant comorbidities (70%). Fifty patients (13%) had marrow plasma cell burden (PCB) of 50 percent or greater. Fifty-five percent of patients had pentaclass exposure, and the median number of previous lines of therapy was seven (range: 4–24); 45 patients (8%) received previous BCMA therapy, and five received prior CAR-T therapy. At a median follow-up of 12 months, the rates of any-grade cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS) were 80 and 22 percent, respectively; Grade 3 or greater CRS and ICANS were rare, both occurring at a rate of four percent. The rate of non-ICANS neurotoxicity was also low, at five percent. Forty-seven percent of patients experienced clinically significant infections. PCB of 50 percent or greater was identified as an independent risk factor for CRS of Grade 2 or greater. Best overall response rate (ORR) was 87 percent, with 35 percent of patients achieving complete response (CR)/stringent CR and 40 percent achieving very good partial response. Estimated 12-month progression-free survival (PFS) was 73 percent and overall survival (OS) was 85 percent. According to multivariable analysis, male sex, high-risk cytogenetics, PCB of 50 percent or greater, prior BCMA therapy, ferritin levels of 150ng/mL or higher, and elevated baseline lactate dehydrogenase (LDH) were associated with decreased PFS. The mortality rate was 15 percent at last follow-up, with a nonrelapse mortality rate of five percent. These findings showed that cilta-cel has a favorable safety and efficacy profile, even in heavily pretreated patients.
An examination of perceived gaps in multiple myeloma education for nurses.
In this study, researchers explored perceived and unrecognized educational gaps regarding MM among oncology nurses. A live continuing education symposium was held, and 601 oncology nurses attended; collectively, they saw 6,700 patients with MM each month and had over 80,000 patient interactions per year. Before the symposium, 56 questions covering 83 topics were submitted by registrants. Common themes included advancements in treatment (n=15), cellular therapy (n=12), side effects (n=10), prognosis (n=8), and laboratory testing (n=8). Attendees were asked four pre- and posttest questions on CRS, transitions of care, the importance of quadruplet therapies, and disparities in MM, and knowledge was gained with each question. Nurses showed a 36.6-percent improvement in correct responses on understanding the impact of quadruplet therapy in achieving minimal residual disease (MRD) negativity. There was a 42.5-percent observed gain on disparities, with a remaining gap of 51.2 percent. These findings illustrate the ongoing need for further MM education for oncology nurses, particularly regarding topics such as treatment strategies and disparities in care.
Quality improvement intervention, the addition of lifestyle medicine group sessions in multiple myeloma population. Lifestyle interventions, such as tailored physical activity and nutrition interventions, are recommended for patients with cancer, but education specifically for patients with MM is limited. As such, researchers conducted a pilot quality improvement lifestyle medicine education intervention, aiming to reduce side effects and improve quality of life. Seven patients participated in the six-week intervention, which included weekly virtual education group sessions on various topics, including physical activity, healthy eating, and social connections. Postintervention survey responses showed that participants agreed or strongly agreed that the intervention “motivated me to take better care of myself” and was “a valuable addition” to their care at the healthcare center. Patients reported healthy behavior changes after the intervention, such as adding 30 minutes of physical activity each day, intentional eating, making more time for social interactions, and meditation. This pilot study demonstrated the potential benefits of a group lifestyle medicine education program for patients with MM.
Clonal hematopoiesis of indeterminate potential (CHIP) does not impact the efficacy of BCMA-directed chimeric antigen receptor (CAR)-T cells in patients with relapsed/refractory multiple myeloma.
In this retrospective, single-center study, researchers evaluated the impact of clonal hematopoiesis of indeterminate potential (CHIP) on CAR-T therapy in patients with RRMM. Of 68 identified patients, 21 (31%) had CHIP mutations. Mean age was comparable between groups, at 66 years for patients with CHIP and 63 years for those without CHIP, and the median number of prior lines of therapy was four for both groups. Additionally, a similar proportion of patients with and without CHIP had high-risk cytogenetics (45% and 50%, respectively). Among patients with CHIP mutations, 15 had only one mutation, and six had two or more mutations. The ORR was similar between groups, at 95 percent for patients with CHIP mutations and 91 percent for those without CHIP mutations (p=0.99). Likewise, the CR rate did not significantly differ, at 81 percent in the CHIP group and 61 percent in the no CHIP group (p=0.10). Survival outcomes were similar across groups. PFS was 1.3 years in the CHIP group and 1.5 years in the no CHIP group (hazard ratio [HR]: 0.95; 95% confidence interval [CI]: 0.41–2.23; p=0.91). Patients with CHIP mutations had a one-year OS rate of 87 percent, compared to 86 percent for patients without CHIP mutations (HR: 0.84; 95% CI: 0.22–3.26; p=0.80). The incidence of CRS was significantly higher among patients with CHIP mutations versus those without CHIP mutations, occurring in all patients versus 70 percent of patients, respectively (p=0.007); similarly, the rate of tocilizumab use for CRS was increased among patients with CHIP mutations compared to those without CHIP mutations (90% vs. 60%; p=0.01). ICANS incidence did not significantly differ between groups, occurring in 33 percent of patients with CHIP mutations and 17 percent of those without CHIP mutations (p=0.20). At Days 90 and 120, the rate of cytopenias was comparable between groups, but patients with CHIP mutations experienced a greater increase in granulocyte colony-stimulating factor use between Days 90 and 120, at 27.8 percent versus five percent for patients without CHIP (p=0.02). CAR-T therapy showed comparable efficacy and survival outcomes regardless of CHIP mutation status, but patients with CHIP mutations should be closely monitored for CRS.
Enhancing patient education and support in multiple myeloma: a toolkit-based nursing intervention.
Nurses are well-positioned to deliver tailored education on treatment and ongoing disease management to patients with MM. This pilot study describes a nurse-led education intervention for patients with newly diagnosed MM (NDMM) and RRMM. Topics covered included disease overview, laboratory and test monitoring, treatment goals, and support resources for NDMM and treatment plan, mechanism of action, side effects, when to seek help, and a treatment calendar for RRMM. Follow-up plans and contact with the care team were emphasized in the intervention. Ten patients completed pre- and postintervention surveys; respondents reported high satisfaction with the education intervention, indicating that the program was supportive, respectful, and clear. The highest-rated item was respect from the care team (mean: 5.0). The lowest-rated item was feeling listened to, but the rating was still favorable (mean: 4.8). Advanced practice providers (APPs) most commonly provided education (63.6%), followed by nurses (54.5%) and pharmacists (45.5%). Patient distress scores did not significantly change from pre- to postintervention (p=0.87). Respondents indicated a preference for visual (100%) and reading/writing (81.8%) educational styles. Nurse surveys indicated stable satisfaction with the standardized education program. Limitations included small sample size and low variability, which illustrate real-world clinical challenges. Furthermore, most participating nurses had been hired within one year of participation, which might have affected confidence in providing education.