Single versus tandem autologous stem-cell transplantation in patients with newly diagnosed multiple myeloma and high-risk cytogenetics. A retrospective, open-label study of the PETHEMA/Spanish Myeloma Group (GEM).

Tandem ASCT has been suggested as a valid approach to improve the prognosis of patients with MM and HR cytogenetic. In this observational, retrospective study, 213 patients with newly diagnosed MM and HR cytogenetic in 35 hospitals from the Spanish Myeloma Group underwent single or tandem ASCT between January 2015 and December 2019 after induction with VTD/VRD. HR cytogenetic was defined as having ≥1 of the following: del17p, t(4;14), t(14;16) or gain 1q21. More patients in the tandem group had R-ISS 3 and >1 cytogenetic abnormality at diagnosis. With a median follow-up of 31 months (range, 10-82), PFS after single ASCT was 41 months versus 48 months with tandem ASCT (p = 0.33). PFS in patients with del17p undergoing single ASCT was 41 months, while 52% of patients undergoing tandem ASCT were alive and disease free at 48 months. In conclusion, tandem ASCT partly overcomes the bad prognosis of HR cytogenetic.

Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study).

BACKGROUND: Ibrutinib demonstrated remarkable efficacy and favorable tolerability in patients with untreated or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), including those with high-risk genetic alterations. The IBRORS-CLL study assessed the characteristics, clinical management and outcome of CLL patients receiving ibrutinib in routine clinical practice in Spain. PATIENTS: Observational, retrospective, multicenter study in CLL patients who started single-agent ibrutinib as first-line treatment or at first or second relapse between January 2016 and January 2019. RESULTS: A total of 269 patients were included (median age: 70.9 years; cardiovascular comorbidity: 55.4%, including hypertension [47.6%] and atrial fibrillation [AF] [7.1%]). Overall, 96.7% and 69% of patients underwent molecular testing for del(17p)/TP53 mutation and IGHV mutation status. High-risk genetic features included unmutated IGHV (79%) and del(17p)/TP53 mutation (first-line: 66.3%; second-line: 23.1%). Overall, 84 (31.2%) patients received ibrutinib as first-line treatment, and it was used as second- and third-line therapy in 121 (45.0%) and 64 (23.8%) patients. The median progression-free survival and overall survival were not reached irrespective of del(17p)/TP53, or unmutated IGHV. Common grade ≥3 adverse events were infections (12.2%) and bleeding (3%). Grade ≥3 AF occurred in 1.5% of patients. CONCLUSION: This real-world study shows that single-agent ibrutinib is an effective therapy for CLL, regardless of age and high-risk molecular features, consistent with clinical trials. Additionally, single-agent ibrutinib was well tolerated, with a low rate of cardiovascular events. This study also emphasized a high molecular testing rate of del(17p)/TP53 mutation and IGHV mutation status in clinical practice according to guideline recommendations.

Health, disability, and consumption of psychoactive substances among people in a homeless situation in León (Nicaragua).

Nicaragua is one of the countries in Latin America with lowest levels of development. In Nicaragua, people in a homeless situation are one of the most socially excluded groups, and there is a lack of data regarding their characteristics, circumstances, and needs. This study examines the state of health, disability, and substance use among people living homeless (n = 68) in the city of León (Nicaragua). Sixty percent of the homeless people contacted responded to a questionnaire which was administered with the respondents by means of an interview. The findings showed that people living homeless in León had very negative states of health and disability, worse than those observed in other socially excluded groups in the same city and homeless people in more developed countries. The interviewees also presented a high level of substance abuse - mainly of alcohol and inhaled glue.

Results of an Early Access Treatment Protocol of Daratumumab Monotherapy in Spanish Patients With Relapsed or Refractory Multiple Myeloma.

Daratumumab is a human CD38-targeted monoclonal antibody approved as monotherapy for heavily pretreated relapsed and refractory multiple myeloma. We report findings for the Spanish cohort of an open-label treatment protocol that provided early access to daratumumab monotherapy and collected safety and patient-reported outcomes data for patients with relapsed or refractory multiple myeloma. At 15 centers across Spain, intravenous daratumumab (16 mg/kg) was administered to 73 patients who had ≥3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug, or who were double refractory to both. The median duration of daratumumab treatment was 3.3 (range: 0.03-13.17) months, with a median number of 12 (range: 1-25) infusions. Grade 3/4 treatment-emergent adverse events were reported in 74% of patients and included lymphopenia (28.8%), thrombocytopenia (27.4%), neutropenia (21.9%), leukopenia (19.2%), and anemia (15.1%). Common (>5%) serious treatment-emergent adverse events included respiratory tract infection (9.6%), general physical health deterioration (6.8%), and back pain (5.5%). Infusion-related reactions occurred in 45% of patients. The median change from baseline in all domains of the EQ-5D-5L and EORTC QLQ-C30 was mostly 0. A total of 18 (24.7%) patients achieved a partial response or better, with 10 (13.7%) patients achieving a very good partial response or better. Median progression-free survival was 3.98 months. The results of this early access treatment protocol are consistent with previously reported trials of daratumumab monotherapy and confirm its safety and antitumoral efficacy in Spanish patients with heavily treated relapsed or refractory multiple myeloma. European Clinical Trials Database number: 2015-002993-19.

Homeless people in León (Nicaragua): Conceptualizing and measuring homelessness in a developing country.

Homelessness is a global phenomenon that affects groups in situations of poverty and social exclusion, in both developed and developing nations. However, the scientific literature on homeless people in developing countries is scant. This work shows the difficulties defining homelessness and examines the necessary criteria for who will be deemed a homeless person in a developing country. Furthermore, the results of the Point-In-Time (PIT) count of homeless people-a measure of the number of homeless people on a specific day-done in the city of León, Nicaragua (population: 185,000). Throughout the PIT count, 82 unduplicated people living in homelessness were tallied (76% male, 23% female), of which 47 answered a questionnaire. Most of the homeless people in León are male, mestizo, of Nicaraguan nationality, with a primary level education or less, and in a situation of chronic homelessness. Results showed a mean age of 47 years for these individuals. Most of the homeless people showed a bad physical appearance, had poor personal hygiene, and wore dirty clothing. Around half of the homeless observed seemed to have problems related to mental health, alcohol, and/or drugs. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Stressful life events among homeless people in León (Nicaragua): Quantity, types, timing, and perceived causality.

Nicaragua is one of Latin America's least developed countries and has a lack of data on homeless people, a stigmatized group living in extreme poverty. We conducted structured interviews with homeless people living in the city of León (Nicaragua; n = 41) to obtain data on the quantity, types, timing, and perceived causality of stressful life events (SLEs) experienced during their childhood and adolescence as well as throughout their adult lives. The findings showed that our participants had experienced a high number of extremely severe SLEs at very early ages and most of these SLEs occurred before they first became homeless. In terms of the perceived causal relationship between SLEs and homelessness, the interviewees mainly attributed being homeless to material, affective, or relationship factors, or an excessive consumption of alcohol and/or drugs. Suffering from multiple and serious SLEs, largely due to living in socioeconomically disadvantaged environments, appears to be an important vulnerability factor in both becoming homeless and chronic homelessness.

Retraction of Complaints Among Female Victims of Intimate Partner Violence Living in Poverty in Nicaragua.

Retraction among female victims of intimate partner violence (IPV) who report their abuser is a major problem in all societies. This article describes a study of 136 female victims of physical IPV living in poverty in Nicaragua, one of the countries with the lowest levels of development in Central America. This article analyses the aspects that differentiate women living in poverty who retracted after reporting IPV from those who did not. The results show that retraction is widespread among female victims of IPV living in poverty in León (Nicaragua). Although it is difficult to predict the retraction behaviour of the respondents, some differences between the women who retracted their complaint and those who did not were observed. A combination of five variables (including personal circumstances and beliefs about the intimate partner relationship and family) was the best alternative for discriminating between women who had retracted and those who had not.

Renin expression in hematological malignancies and its role in the regulation of hematopoiesis.

It has been demonstrated that some myeloid blasts express renin, but normal bone marrow (BM) does not display this expression. The aim of the present work was to analyze the renin expression in different hematological malignancies and different myeloid cell lines. We investigated the expression of renin by RT-PCR in BM from patients with hematological malignancies (106 patients), in nine normal BM from healthy donors and in leukemic cell lines (K562, KU812, MEG-01, U-937 and HL60), as well in K562 cell line subjected to differentiation treatments. We have observed renin expression in cells from acute myeloid leukemia (AML), chronic myelogenous leukemia (CML) and acute lymphoblastic leukemia (ALL) cases. The highest frequency was observed in AML-non acute promyelocytic leukemia(APL) cases (47.2% of the cases). The disappearance of this expression was associated with the status of complete remission of AML. Renin is expressed in some myeloid human leukemia cell lines such as K562, KU812 and MEG-01. However, when K562 cells were treated with inducers of growth inhibition and/or differentiation, the expression did not disappear, indicating that renin expression is associated with a blastic phenotype rather than with cell proliferation. The obtained findings suggest that the renin expression could have a role on the disease development and could be used as an aberrant marker of leukemia.