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Summary: Previous studies suggest that postautologous stem cell transplant (ASCT) recovery of polyclonal immunoglobulin from immunoparesis in patients with multiple myeloma is a positive prognostic marker. We performed a longitudinal analysis of polyclonal immunoglobulin concentrations and unique B‐cell sequences in patients enrolled in the phase 3 ATLAS trial that randomized 180 subjects to either carfilzomib, lenalidomide, dexamethasone (KRd) or lenalidomide (R) maintenance. In the KRd arm, standard‐risk patients with minimal residual disease negativity after six cycles de‐escalated to R alone after cycle 8. One year from the initiation of maintenance at least partial recovery of polyclonal immunoglobulin was observed in more patients on the R arm (58/66, p < 0.001) and in those who de‐escalated from KRd to R (27/38, p < 0.001) compared to the KRd arm (9/36). In patients who switched from KRd to R, the concentrations of uninvolved immunoglobulin and the number of B‐cell unique sequences increased over time, approaching values observed in the R arm. There were no differences in progression‐free survival between the patients with at least partial immunoglobulin recovery and the remaining population. Our analysis indicates that patients receiving continuous therapy after ASCT experience prolonged immunoparesis, limiting prognostic significance of polyclonal immunoglobulin recovery in this setting. [ABSTRACT FROM AUTHOR]

Introduction: There is little iterature data regarding neutropenic enterocolitis (NE) development after autologous hematopoietic cell transplantation (auto-HCT) in non-Hodgkin lymphoma (NHL) patients. The aim of this study was to determine the incidence, risk factors, and clinical outcome of NE after auto-HCT in NHL patients with respect to the impact of multidrug-resistant Gram-negative bacteria (MDRG) and vancomycin-resistant enterococci colonization on the early outcome after auto-HCT. Material and methods: This retrospective single-center analysis included a total of 65 NHL patients who underwent auto-HCT after BEAM (BCNU, etoposide, cytosine arabinoside, melphalan) conditioning (BEAM-auto-HCT). Results: NE was diagnosed in nine (13.8%) patients, a median four days after auto-HCT. In 6/9 (66%) patients, septic shock following NE was diagnosed. In univariate analysis, MDRG colonization before BEAM-auto-HCT was the only factor significant for NE development [odds ratio (OR) 2.4 (1.14-5.0), p = 0.027], although this was not confirmed in multivariate analysis. Additionally, NE [OR 5.2 (1.9-13.9), p = 0.001] and MDRG colonization prior to transplant [OR 2.7 (1.0-7.0), p = 0.041] were independent factors for septic shock development. Conclusions: Our findings suggest that NHL patients presenting with MDRG colonization before transplant should be kept under careful surveillance because of the high risk of the development of early severe infectious complications, including abdominal ones. [ABSTRACT FROM AUTHOR]

Introduction: Multiple myeloma (MM) is the leading indication for autologous stem cell transplantation (ASCT), with over 12,000 transplants per year in Europe. Due to low toxicity, an entirely outpatient procedure or an early discharge after ASCT can be considered as alternatives to inpatient transplantation. Thus, we launched an Early Discharge Program (EDP) for patients qualified for ASCT due to MM who were under 60 years of age, without significant comorbidities, who had a caregiver available 24/7, and who lived within a 60-minute drive of our hospital. Material and methods: Patients spent 72 hours in the hospital being administered melphalan 200 mg/m2 intravenous followed by an infusion of hematopoietic stem cells. They were eventually discharged and remained under outpatient care. The program was launched in September 2019 and was temporarily halted due to the coronavirus disease 19 (COVID-19) pandemic in early 2020. Five patients were enrolled to the EDP. Results: Non-hematological toxicity was mild and manageable in an outpatient setting. Only one patient was readmitted due to exacerbation of ulcerative colitis that was probably not related to ASCT. We observed neither infections nor bleeding. Due to hematological toxicity, three of the five patients received platelet transfusion on the 6th day after ASCT as outpatients. No packed erythrocytes were transfused. The EDP demonstrated lower costs compared to an inpatient approach. Conclusions: We believe that early discharge, which is an intermediate step to full at-home transplantation due to patients' wellbeing, reduction of infections caused by resistant microorganisms, and costs, will eventually replace a full inpatient procedure for a significant population of patients suffering from multiple myeloma and indeed other diseases. [ABSTRACT FROM AUTHOR]

Aim of the study: The aim of the study was to determine the incidence of second malignancies among patients with Hodgkin lymphoma (HL) treated with autologous ha ematopoietic stem cell trans plantation (ASCT) following a modi fied BEAM (BCNU, etoposide, cytarabine, melphalan, dexa methasone) regimen between 1992 and 2012 at our department. We also intended to define the risk factors for the occurrence of second neoplasm after ASCT. Material and methods: The long-term outcomes after transplant were evaluated in 170 patients, median age 31 years (range 17-61), who received amedian of two pre-transplant chemo therapy lines (range 1-5). Results: MOPP (me chlorethamine, vincristine, procarbazine, prednisone) or MOPP-type regimens were given to 12% of patients prior to ASCT. The median follow- up of the survivors was 73 (12-242) months. The 7-year overall survival and progression-free survival were 75% and 64%, respectively. Second malignancies occurred in 7 of the 170 patients, including 5 haematological malignancies, and 2 solid tumors. They developed at amedian of 8 years (range 0.4-13.5) from ASCT. The 10-year and 15-year cumulative incidence of developing a second malignancy were 7% and 13%, respectively. In multivariate analysis, age ≥40 years at transplant (HR = 8.8; p = 0.008) and pre-transplant MOPP-type chemotherapy (HR = 5.6; p = 0.030) were the only factors significant for developing a second malignancy. Conclusions: Our results indicate that age of patient and the type of pre-transplant chemotherapy contribute to the risk of the development of a second neoplasm after ASCT in patients with HL. We believe that better characterization of second malignancies and associated risk factors may be useful for clinicians who care for these patients. [ABSTRACT FROM AUTHOR]

Lenalidomide is a cornerstone of maintenance therapy in patients with newly diagnosed multiple myeloma after autologous stem-cell transplantation. We aimed to compare the efficacy and safety of maintenance therapy with carfilzomib, lenalidomide, and dexamethasone versus lenalidomide alone in this patient population. This study is an interim analysis of ATLAS, which is an investigator-initiated, multicentre, open-label, randomised, phase 3 trial in 12 academic and clinical centres in the USA and Poland. Participants were aged 18 years or older with newly diagnosed multiple myeloma, completed any type of induction and had stable disease or better, autologous stem-cell transplantation within 100 days, initiated induction 12 months before enrolment, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomly assigned (1:1) using permuted blocks of sizes 4 and 6 and a web-based system to receive up to 36 cycles of carfilzomib, lenalidomide, and dexamethasone (28-day cycles of carfilzomib 20 mg/m2 administered intravenously in cycle one on days 1 and 2 then 36 mg/m2 on days 1, 2, 8, 9, 15, and 16 in cycles one to four and 36 mg/m2 on days 1, 2, 15, and 16 from cycle five up to 36 [per protocol]; lenalidomide 25 mg administered orally on days 1–21; and dexamethasone 20 mg administered orally on days 1, 8, 15, and 22) or lenalidomide alone (10 mg administered orally for the first three cycles and then at the best tolerated dose [≤15 mg for 28 days in 28-day cycles]) until disease progression or unacceptable toxicity as maintenance therapy. After 36 cycles, patients in both treatment groups received lenalidomide maintenance. Randomisation was stratified by response to previous treatment, cytogenetic risk factors, and country. Investigators and patients were not masked to treatment allocation. Patients in the carfilzomib, lenalidomide, and dexamethasone group with no detectable minimal residual disease after cycle six (as per International Myeloma Working Group criteria) and standard-risk cytogenetics were switched to lenalidomide maintenance as of cycle nine. The primary endpoint was progression-free survival in the intention-to-treat population (defined as all randomly assigned patients). Safety was analysed in all randomly assigned patients who received at least one dose of study treatment. This unplanned interim analysis was triggered by the occurrence of 59 (61%) of the expected 96 events for the primary analysis and the results are considered preliminary. This trial is registered with ClinicalTrials.gov , NCT02659293 (active, not recruiting) and EudraCT, 2015–002380–42. Between June 10, 2016, and Oct 21, 2020, 180 patients were randomly assigned to receive either carfilzomib, lenalidomide, and dexamethasone (n=93) or lenalidomide alone (n=87; intention-to-treat population). The median age of patients was 59·0 years (IQR 49·0–63·0); 84 (47%) patients were female and 96 (53%) were male. With a median follow-up of 33·8 months (IQR 20·9–42·9), median progression-free survival was 59·1 months (95% CI 54·8–not estimable) in the carfilzomib, lenalidomide, and dexamethasone group versus 41·4 months (33·2–65·4) in the lenalidomide group (hazard ratio 0·51 [95% CI 0·31–0·86]; p=0·012). The most common grade 3 and 4 adverse events were neutropenia (44 [48%] in the carfilzomib, lenalidomide, and dexamethasone group vs 52 [60%] in the lenalidomide group), thrombocytopenia (12 [13%] vs six [7%]), and lower respiratory tract infections (seven [8%] vs one [1%]). Serious adverse events were reported in 28 (30%) patients in the carfilzomib, lenalidomide, and dexamethasone group and 19 (22%) in the lenalidomide group. One treatment-related adverse event led to death (respiratory failure due to severe pneumonia) in the carfilzomib, lenalidomide, and dexamethasone group. This interim analysis provides support for considering carfilzomib, lenalidomide, and dexamethasone therapy in patients with newly diagnosed multiple myeloma who completed any induction regimen followed by autologous stem-cell transplantation, which requires confirmation after longer follow-up of this ongoing phase 3 trial. Amgen and Celgene (Bristol Myers Squibb). [ABSTRACT FROM AUTHOR]