Search

PURPOSE Idecabtagene vicleucel (ide-cel) is an autologous B-cell maturation antigen–directed chimeric antigen receptor T-cell therapy approved for relapsed/refractory multiple myeloma (RRMM) on the basis of the phase II pivotal KarMMa trial, which demonstrated best overall and ≥ complete response rates of 73% and 33%, respectively. We report clinical outcomes with standard-of-care (SOC) ide-cel under the commercial Food and Drug Administration label. METHODS Data were retrospectively collected from patients with RRMM who underwent leukapheresis as of February 28, 2022, at 11 US institutions with intent to receive SOC ide-cel. Toxicities were graded per American Society for Transplantation and Cellular Therapy guidelines and managed according to each institution's policies. Responses were graded on the basis of the International Myeloma Working Group response criteria. RESULTS One hundred fifty-nine of 196 leukapheresed patients received ide-cel by data cutoff. One hundred twenty (75%) infused patients would have been ineligible for participation in the KarMMa clinical trial because of comorbidities at the time of leukapheresis. Any grade and grade ≥ 3 cytokine release syndrome and neurotoxicity occurred in 82/3% and 18/6%, respectively. Best overall and ≥ complete response rates were 84% and 42%, respectively. At a median follow-up of 6.1 months from chimeric antigen receptor T infusion, the median progression-free survival was 8.5 months (95% CI, 6.5 to not reached) and the median overall survival was 12.5 months (95% CI, 11.3 to not reached). Patients with previous exposure to B-cell maturation antigen–targeted therapy, high-risk cytogenetics, Eastern Cooperative Oncology Group performance status ≥ 2 at lymphodepletion, and younger age had inferior progression-free survival on multivariable analysis. CONCLUSION The safety and efficacy of ide-cel in patients with RRMM in the SOC setting were comparable with those in the phase II pivotal KarMMa trial despite most patients (75%) not meeting trial eligibility criteria.

Which career path will enable me to see the impact of my work in real time in improving a patient's life? I wondered this until I earned my first nursing degree, followed by a nurse practitioner degree. Soon after, two highly competitive opportunities, a year-long advanced practice RN fellowship and a month-long National Institute of Nursing Research Summer Genetics Institute at the National Institutes of Health, really helped me to have the necessary training and knowledge to shape my career. So, when I got an opportunity to become a research nurse practitioner and manage chimeric antigen receptor (CAR) T-cell therapy clinical trials for patients with multiple myeloma, I knew I had found an answer to my question.

Problem identification A lack of testing options for the diagnosis and prognosis of chronic graft-versus-host disease (cGVHD) is a barrier to clinical management. Studies that have investigated the role of blood proteins as diagnostic and prognostic biomarkers for cGVHD were reviewed. Literature search PubMed and Scopus databases were searched for articles published from January 1, 2000, to May 31, 2019. 660 articles were retrieved. Data evaluation The authors appraised seven articles based on the inclusion and exclusion criteria to summarize identified blood protein biomarkers for cGVHD. Synthesis Several blood proteins were identified as potential diagnostic and prognostic biomarkers. Most of these proteins are thought to be key contributors in cGVHD pathogenesis and, therefore, could be ideal biomarkers to guide clinical management. Implications for practice These biomarkers could aid providers in diagnosing cGVHD, identifying patients at high risk for development of cGVHD, and initiating preemptive therapy.

8042 Background: Ide-cel, a BCMA directed CAR T-cell therapy, was FDA approved 3/26/2021 for the treatment of RRMM after 4 prior lines of therapy. We evaluated the real-world outcomes of patients treated with standard of care ide-cel under the commercial FDA label. Methods: Ten US academic centers contributed data to this effort independent of the manufacturer. As of 1/10/2022, 138 patients were leukapheresed with overall manufacturing failure in 6 (4%). 108 patients were infused ≥ 30 days prior to data-cut off and constitute the study population for this retrospective analysis. Results: Table describes the study population compared to the pivotal KarMMa-1 trial (Munshi et al, NEJM 2021). Patients in our study were less likely to have ECOG PS of 0/1 (77%) and more likely to be penta-refractory (41%). 67% of patients would not have met eligibility criteria for KarMMa. Common reasons for ineligibility (> 1 reason in 22% patients) were co-morbidities (28%), cytopenias (22%), prior therapy with alloSCT/CAR-T/other BCMA therapy (19%), CNS myeloma/non-measurable disease/plasma cell leukemia (13%), and fitness (12%). 81% of patients received bridging therapy. Toxicity was comparable to that seen in KarMMa-1. Cytokine release syndrome (CRS) was seen in 82% (> grade 3: 4%) and immune effector cell-associated neurotoxicity syndrome (ICANS) in 15% (> grade 3: 5%) of patients, respectively. Tocilizumab and steroids were used in 72% and 25% of patients, respectively. Infections were seen in 34% of patients. Day 30 response was evaluable in 104 patients. Response rates were: ≥ partial response, 83%; ≥ very good partial response, 64%; and ≥ complete response (CR), 34%. 11% of patients have died by data cut-off, 7 due to disease progression and 5 due to other causes (1 grade 5 CRS, 1 hemophagocytic lymphohistiocytosis, 1 progressive neurological weakness, 2 COVID-19). Conclusions: This multicenter retrospective study delineates the real-world outcomes of ide-cel CAR T-cell therapy for RRMM. Despite more patients being penta-refractory and less fit compared to the pivotal KarMMa trial, safety and 30-day responses in the real-world setting (overall response rate: 83%, CR: 34%) are comparable to the clinical trial population. Follow-up is ongoing and updated data will be presented. [Table: see text]

Background Pharmacokinetics (PK) is the study of the absorption, distribution, metabolism, and excretion of drugs. Many chemotherapeutic agents have a sensitive PK index, in which a small margin in blood concentrations is the difference between nontherapeutic, therapeutic, and adverse outcomes. Objectives This article will provide an overview of evidence-based approaches to the collection of PK samples, monitoring of PK levels, and the resulting management of patients undergoing PK testing. Methods A case study involving busulfan, an alkylating agent used in the pre-stem cell transplantation setting, will highlight the cross-contamination of samples while a drug is being infused through a central venous catheter with PK sample collection from a proximal peripherally inserted central catheter. The influence of false elevations in drug concentrations on PK-guided dose adjustments will also be emphasized. Findings Imprecise blood collections or cross-contamination of samples may lead to inaccurate drug concentration results and, subsequently, undesired low or high drug dosage calculations.

Background After allogeneic hematopoietic stem cell transplantation, one of the major barriers to clinical management of acute graft-versus-host disease (aGVHD) is a lack of reliable and validated noninvasive tests for diagnosis and prognosis. Proteomic studies have indicated a strong correlation between the level of certain body fluid proteins and clinical outcomes after aGVHD. Specific proteins have been identified that could be robust biomarkers for overall prognosis or for differential diagnosis of target organs in aGVHD. Objectives The authors aimed to evaluate the literature related to proteomic biomarkers that are indicated in the occurrence, severity, and management of aGVHD. Methods PubMed and CINAHL® databases were searched for articles published from January 2004 to June 2014. Eight articles matching the inclusion criteria were identified, and the findings of these articles were summarized and their clinical implications noted. Findings Proteomics appears to be a promising tool to assist oncology nurses and nurse practitioners with patient education, develop personalized plans of care to reduce morbidity, initiate communication regarding end-of-life decisions, and improve overall nursing management of the population of patients with aGVHD.

ONF, 42(4), 415–419. doi: 10.1188/15.ONF.415-419 A 36-year-old man presented to an emergency room with fever, fatigue, and severe rectal pain. He was subsequently found to be pancytopenic with a perirectal abscess. A bone marrow examination revealed 58% blasts consistent with acute myeloid leukemia. The patient was initiated on clofarabine, idarubicin, and cytarabine therapy. The first cycle of therapy was complicated by neutropenic fever, bacteremia, and pneumonia. The second cycle was complicated by delayed platelet recovery. As a result, the patient was referred for possible stem cell transplantation. The patient was enrolled in a phase III trial using standard of care double umbilical cord blood transplantation with myeloblative conditioning to include fludarabine and melphalan, with rabbit antithymocyte globulin. Filgrastim injections were initiated at 600 mcg daily. The patient’s post-transplantation phase was complicated by sustained rigors and recurrent febrile episodes. The patient experienced 1–6 episodes of rigors daily. During this period, the patient also reported severe lower back pain with a majority of the episodes of rigor. The patient then developed neutropenic fever on Day 17 with persistent fever daily ranging from 38.1°–39.5°C through Day 50, with only six days in which he was afebrile. Filgrastim injections were administered at 4 pm daily, and the febrile episodes were noted to occur primarily in the early to late evening hours, with rigors preceding the febrile events by about 30–60 minutes. By Day 30, the patient’s engraftment had plateaued with a white blood cell count of 1.2 and an absolute neutrophil count of 0.89. As a result, the filgrastim dose was increased to 600 mcg twice daily. Diagnostic Workup

MicroRNAs are novel biomolecules with a crucial function in normal cellular physiology and in pathophysiologic conditions, including cancer. Since the first report on the link between microRNAs and cancer was published in 2002, research has revealed the potential clinical implications of microRNAs. Oncology nurses play an important role in educating patients and their families about possible applications of microRNAs in oncology. .

Many epidemiologic and laboratory studies in the recent past suggested that the physiology of the eye may be affected by alterations in sex steroid homeostasis due to ageing and pathogenesis. This hypothesis is again strengthened by the presence of specific receptors for steroid hormones in various ocular tissues. However their involvement in pathological process is not yet clearly established. This review deals with a viewpoint on the possible beneficial and detrimental effects of sex steroids on ocular physiopathology. Since sex steroids are different in males and females, an interesting concept of sexual dimorphism in human eye also emerges from this information.