المؤلفون: Soler, Alfons, Garcia Sanchez, Ricarda, Pérez Persona, Ernesto, Arnao Herraiz, Mario, García-Guiñón, Antoni, Domingo, Abel, González Pardo, Miriam, de la Rubia, Javier, Mateos, María-Victoria, Ríos-Tamayo, Rafael

المساهمون: Ríos-Tamayo R Department of Hematology, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain. Soler JA Department of Hematology, HospitalUniversitari Parc Taulí de Sabadell, Catalonia, Spain. García-Sánchez R Department of Hematology, Hospital Virgen de la Victoria, Málaga, Spain. Pérez Persona E Department of Hematology, Hospital Universitario de Navarra, Pamplona, Spain. Arnao M Department of Hematology, Hospital Universitari i Politècnic La Fe, Valencia, Spain. García-Guiñón A Department of Hematology, Hospital Universitari Arnau de Vilanova, Lleida, Spain. Domingo A Department of Hematology, Hospital General de Granollers, Granollers, Spain. González-Pardo M Medical Department, Janssen-Cilag España, Spain. de la Rubia J Hospital Universitari i Politècnic La Fe, Valencia, Spain. Hematology Department, Universidad Católica“San Vicente Mártir”, Valencia, Spain. CIBERONC CB16/12/00284,Valencia, Spain. Mateos MV Instituto de Investigación Biomédica de Salamanca (IBSAL), Centro de Investigación del Cancer (IBMCC-USAL, CSIC), Hospital Universitario de Salamanca, Salamanca, Spain, Hospital General de Granollers

المصدر: Scientia

مصطلحات موضوعية: Mieloma múltiple, Anticossos monoclonals, Medicaments - Eficàcia, DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Plasma Cell::Multiple Myeloma, CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal, PUBLICATION CHARACTERISTICS::Study Characteristics::Multicenter Study, ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias de células plasmáticas::mieloma múltiple, COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales, CARACTERÍSTICAS DE PUBLICACIONES::características del estudio::estudio multicéntrico

الوصف: Relapsed-refractory multiple mieloma; Monoclonal antibodies; Observational multicenter study ; Mieloma múltiple recidivant-refractari; Anticossos monoclonals; Estudi observacional multicèntric ; Mieloma múltiple recidivante-refractario; Anticuerpos monoclonales; Estudio multicéntrico observacional ; Objectives: To describe the incorporation of monoclonal antibodies (mAb) in real-world (RW) practice for the treatment of patients with relapsed refractory multiple myeloma (RRMM) in a setting with other treatment alternatives. Methods: This was an observational, multicenter, ambispective study of RRMM treated with or without a mAb. Results: A total of 171 patients were included. For the group treated without mAb, the median (95% CI) progression-free survival (PFS) to relapse was 22.4 (17.8-27.0) months; partial response or better (≥PR) and complete response or better (≥CR) was observed in 74.1% and 24.1% of patients, respectively; and median time to first response in first relapse was 2.0 months and in second relapse was 2.5 months. For the group of patients treated with mAb in first or second relapse, the median PFS was 20.9 (95% CI, could not be evaluated) months; the ≥ PR and ≥ CR rates were 76,2% and 28.6%, respectively; and the median time to first response in first relapse was 1.2 month and in second relapse was 1.0 months. The safety profiles for the combinations were consistent with those expected. Conclusions: The incorporation of mAb in RW practice for the treatment of RRMM has shown good quality and speed of response with a similar safety profile shown in randomized clinical trials. Keywords: Relapsed-refractory multiple myeloma; daratumumab; monoclonal antibodies; real-world; standard of care.

وصف الملف: application/pdf

العلاقة: Hematology;28(1); https://doi.org/10.1080/16078454.2023.2178997Test; Ríos-Tamayo R, Soler JA, García-Sánchez R, Pérez Persona E, Arnao M, García-Guiñón A, et al. A glimpse into relapsed refractory multiple myeloma treatment in real-world practice in Spain: the GeminiS study. Hematology. 2023 Dec;28(1):2178997.; https://hdl.handle.net/11351/9425Test

الإتاحة: https://doi.org/10.1080/16078454.2023.2178997Test
https://hdl.handle.net/11351/9425Test

المؤلفون: Ríos-Tamayo, R., Soler, Joan Alfons, García-Sánchez, Ricarda, Pérez Persona, Ernesto, Arnao‐Herráiz, Mario, Garcia-Guiñon, Antonio, Domingo, Abel, González-Pardo, Miriam, Rubia, Javier de la, Mateos, Maria Victoria

المساهمون: Janssen Biotech

مصطلحات موضوعية: Relapsed-refractory multiple myeloma, Real-world, Monoclonal antibodies, Daratumumab, Standard of care

الوصف: Objectives: To describe the incorporation of monoclonal antibodies (mAb) in real-world (RW) practice for the treatment of patients with relapsed refractory multiple myeloma (RRMM) in a setting with other treatment alternatives. Methods: This was an observational, multicenter, ambispective study of RRMM treated with or without a mAb. Results: A total of 171 patients were included. For the group treated without mAb, the median (95% CI) progression-free survival (PFS) to relapse was 22.4 (17.8-27.0) months; partial response or better (≥PR) and complete response or better (≥CR) was observed in 74.1% and 24.1% of patients, respectively; and median time to first response in first relapse was 2.0 months and in second relapse was 2.5 months. For the group of patients treated with mAb in first or second relapse, the median PFS was 20.9 (95% CI, could not be evaluated) months; the ≥ PR and ≥ CR rates were 76,2% and 28.6%, respectively; and the median time to first response in first relapse was 1.2 month and in second relapse was 1.0 months. The safety profiles for the combinations were consistent with those expected. Conclusions: The incorporation of mAb in RW practice for the treatment of RRMM has shown good quality and speed of response with a similar safety profile shown in randomized clinical trials. ; This study was sponsored by Janssen-Cilag.

وصف الملف: application/pdf

العلاقة: Publisher's version; http://dx.doi.org/10.1080/16078454.2023.2178997Test; Sí; Hematology 28(1): 2178997 (2023); http://hdl.handle.net/10261/337306Test

الإتاحة: https://doi.org/10.1080/16078454.2023.2178997Test
http://hdl.handle.net/10261/337306Test

المؤلفون: Asensi Cantó, Pedro, Arnao Herraiz, Mario, de la Rubia Comos, Javier

المصدر: Medicina Clínica (ScienceDirect); May 2024, Vol. 162 Issue: 10 p485-493, 9p

مستخلص: Los pacientes con mieloma múltiple que presentan una enfermedad refractaria o en recaída tras recibir las principales clases de fármacos disponibles —inmunomoduladores, inhibidores del proteosoma y anticuerpos frente a CD38— no disponen de alternativas terapéuticas satisfactorias. Los nuevos tratamientos basados en la redirección de los linfocitos T para que actúen directamente contra las células tumorales, como los anticuerpos biespecíficos y las células T con receptores antigénicos quiméricos, están cambiando este escenario. La información disponible confirma una actividad antitumoral de estos agentes sin precedentes en los pacientes con mieloma refractario y, con seguridad, formarán la columna vertebral del tratamiento de estos pacientes en un futuro inmediato. Sin embargo, estas terapias también presentan características específicas y toxicidades a medio o largo plazo que plantean nuevos retos asistenciales. En esta revisión abordamos los resultados actuales y desafíos futuros de la administración de estos tratamientos en los pacientes con mieloma múltiple en recaída o refractario.

المؤلفون: Puig, Noemi, Hernandez, Miguel T., Rosiñol, Laura, Gonzalez, Maria-Esther, Arriba, Felipe de, Oriol, Albert, Gonzalez-Calle, David, Escalante, Fernando, Rubia, Javier de la, Gironella, Mercedes, Ríos, Rafael, García-Sánchez, Ricarda, Arguiñano, José M., Alegre, Adrian, Martín, Jesús, Gutiérrez, Norma Carmen, Calasanz, Mª Jose, Martín, María L., Couto, María del Carmen, Casanova, María, Arnao‐Herráiz, Mario, Pérez-Persona, Ernesto, Garzón, Sebastián, González, Marta S., Martín-Sánchez, Guillermo, Ocio, Enrique M., Coleman, Morton, Encinas, Cristina, Vale, Ana M., Teruel, Ana-Isabel, Cortés-Rodríguez, María, Paiva, Bruno, Cedena, Maria-Teresa, San Miguel, Jesús F., Lahuerta, Juan José, Bladé, Joan, Niesvizky, Ruben, Mateos, Maria Victoria

مصطلحات موضوعية: Myeloma, Randomized controlled trials

الوصف: © The Author(s) 2021. ; Although case-control analyses have suggested an additive value with the association of clarithromycin to continuous lenalidomide and dexamethasone (Rd), there are not phase III trials confirming these results. In this phase III trial, 286 patients with MM ineligible for ASCT received Rd with or without clarithromycin until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). With a median follow-up of 19 months (range, 0–54), no significant differences in the median PFS were observed between the two arms (C-Rd 23 months, Rd 29 months; HR 0.783, p = 0.14), despite a higher rate of complete response (CR) or better in the C-Rd group (22.6% vs 14.4%, p = 0.048). The most common G3–4 adverse events were neutropenia [12% vs 19%] and infections [30% vs 25%], similar between the two arms; however, the percentage of toxic deaths was higher in the C-Rd group (36/50 [72%] vs 22/40 [55%], p = 0.09). The addition of clarithromycin to Rd in untreated transplant ineligible MM patients does not improve PFS despite increasing the ≥CR rate due to the higher number of toxic deaths in the C-Rd arm. Side effects related to overexposure to steroids due to its delayed clearance induced by clarithromycin in this elderly population could explain these results. The trial was registered in clinicaltrials.gov with the name GEM-CLARIDEX: Ld vs BiRd and with the following identifier NCT02575144. The full trial protocol can be accessed from ClinicalTrials.gov. This study received financial support from BMS/Celgene.

العلاقة: Publisher's version; http://dx.doi.org/10.1038/s41408-021-00490-8Test; Sí; Blood Cancer Journal 11 (2021); http://hdl.handle.net/10261/261640Test

الإتاحة: https://doi.org/10.1038/s41408-021-00490-8Test
http://hdl.handle.net/10261/261640Test

المؤلفون: Gonzalez-Rodriguez, Ana Pilar, Lopez-Corral, Lucia, Fajardo, David Fernando Moreno, Gonzalez-Huerta, Ana Julia, Palomo, Pilar, Bermudez, Arantxa, Ripa, Teresa Zudaire, Santos-Diaz, Patricia, Gonzalez-Muñiz, Soledad, Zanabilli, Joud, Jimenez Ubieto, Ana, de Arriba, Felipe, Arnao-Herraiz, Mario, Sordo-Bahamonde, Christian, López-Soto, Alejandro, Gonzalez, Segundo, Rosiñol, Laura, Mateos, María-Victoria

المساهمون: Ministry of Economy and Competitiveness | Instituto de Salud Carlos III

المصدر: Bone Marrow Transplantation ; volume 55, issue 2, page 461-463 ; ISSN 0268-3369 1476-5365

مصطلحات موضوعية: Transplantation, Hematology

الإتاحة: https://doi.org/10.1038/s41409-019-0525-1Test
https://www.nature.com/articles/s41409-019-0525-1.pdfTest
https://www.nature.com/articles/s41409-019-0525-1Test

المؤلفون: Ríos-Tamayo, R., Soler, Joan Alfons, García-Sánchez, Ricarda, Pérez Persona, Ernesto, Arnao‐Herráiz, Mario, Garcia-Guiñon, Antonio, Domingo, Abel, González-Pardo, Miriam, Rubia, Javier de la, Mateos, Maria Victoria

المساهمون: Janssen-Cilag, Consejo Superior de Investigaciones Científicas https://ror.org/02gfc7t72Test

مصطلحات موضوعية: Relapsed-refractory multiple myeloma, Real-world monoclonal, Antibodies, Daratumumab, Standard of care

الوصف: To describe the incorporation of monoclonal antibodies (mAb) in real-world (RW) practice for the treatment of patients with relapsed refractory multiple myeloma (RRMM) in a setting with other treatment alternatives. This was an observational, multicenter, ambispective study of RRMM treated with or without a mAb. A total of 171 patients were included. For the group treated without mAb, the median (95% CI) progression-free survival (PFS) to relapse was 22.4 (17.8-27.0) months; partial response or better (≥PR) and complete response or better (≥CR) was observed in 74.1% and 24.1% of patients, respectively; and median time to first response in first relapse was 2.0 months and in second relapse was 2.5 months. For the group of patients treated with mAb in first or second relapse, the median PFS was 20.9 (95% CI, could not be evaluated) months; the ≥ PR and ≥ CR rates were 76,2% and 28.6%, respectively; and the median time to first response in first relapse was 1.2 month and in second relapse was 1.0 months. The safety profiles for the combinations were consistent with those expected. The incorporation of mAb in RW practice for the treatment of RRMM has shown good quality and speed of response with a similar safety profile shown in randomized clinical trials. ; This study was sponsored by Janssen-Cilag. Janssen-Cilag participated in the study design, data analysis and drafting of the manuscript ; Peer reviewed

وصف الملف: application/msword

العلاقة: Publisher's version; Ríos-Tamayo, R.; Soler, Joan Alfons; García-Sánchez, Ricarda; Pérez Persona, Ernesto; Arnao‐Herráiz, Mario; Garcia-Guiñon, Antonio; Domingo, Abel; González-Pardo, Miriam; Rubia, Javier de la; Mateos, Maria Victoria. A glimpse into relapsed refractory multiple myeloma treatment in real-world practice in Spain: the GeminiS study. http://dx.doi.org/10.1080/16078454.2023.2178997Test . http://hdl.handle.net/10261/337306Test; https://doi.org/10.6084/m9.figshare.22794424.v1Test; Sí; Ríos-Tamayo, R.; Soler, Joan Alfons; García-Sánchez, Ricarda; Pérez Persona, Ernesto; Arnao‐Herráiz, Mario; Garcia-Guiñon, Antonio; Domingo, Abel; González-Pardo, Miriam; Rubia, Javier de la; Mateos, Maria Victoria; 2023; A glimpse into relapsed refractory multiple myeloma treatment in real-world practice in Spain: the GeminiS study [Dataset]; Taylor & Francis; https://doi.org/10.6084/m9.figshare.22794424.v1Test; http://hdl.handle.net/10261/360735Test

الإتاحة: https://doi.org/10.6084/m9.figshare.22794424.v110.1080/16078454.2023.2178997Test
http://hdl.handle.net/10261/360735Test

المؤلفون: Villalba, Ana, Gonzalez-Rodriguez, Ana Pilar, Arzuaga-Mendez, Javier, Puig, Noemi, Arnao‐Herráiz, Mario, Arguiñano, José M., Jiménez, María, Canet, Marta, Teruel, Ana-Isabel, Sola, María, Díaz, Francisco J., Encinas, Cristina, García, Antonio, Rosiñol, Laura, Suárez, Alexia, Gonzalez, Marta-Sonia, Izquierdo, Isabel, Hernandez, Miguel T., Infante, María Stefania, Sánchez, María José, Sampol, Antonia, Rubia, Javier de la

مصطلحات موضوعية: Multiple myeloma, Autologous stem cell transplantation, High-risk cytogenetics, Tandem transplantation

الوصف: 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.

العلاقة: http://dx.doi.org/10.1080/10428194.2022.2123229Test; Sí; e-issn: 1029-2403; Leukemia and Lymphoma 63: 3438-3447 (2022); http://hdl.handle.net/10261/297107Test

الإتاحة: https://doi.org/10.1080/10428194.2022.2123229Test
http://hdl.handle.net/10261/297107Test

المؤلفون: Asensi Cantó, Pedro, Arnao Herraiz, Mario, de la Rubia Comos, Javier

المصدر: Med Clin (Barc) ; ISSN:1578-8989 ; Volume:162 ; Issue:10

مصطلحات موضوعية: Anticuerpo biespecífico, Bispecific antibody, CAR-T cells, Células CAR-T, Immunotherapy, Inmunoterapia, Mieloma múltiple, Multiple myeloma

الوصف: Patients with multiple myeloma who present with refractory disease or relapse after receiving the main classes of available drugs -immunomodulators, proteasome inhibitors and antibodies against CD38- do not have satisfactory therapeutic alternatives. New treatments based on the redirection of T lymphocytes to act directly against tumor cells, such as bispecific antibodies and T cells with chimeric antigen receptors, are changing this scenario. The published information confirms unprecedented antitumor activity of these agents in patients with refractory myeloma and they will certainly represent the backbone of the treatment of these patients in the immediate future. However, these therapies also present specific characteristics and medium or long-term toxicities that pose new healthcare challenges. In this review, we address the current results and future challenges of the administration of these treatments in patients with relapsed or refractory multiple myeloma.

العلاقة: https://doi.org/10.1016/j.medcli.2023.11.019Test; https://pubmed.ncbi.nlm.nih.gov/38218655Test

الإتاحة: https://doi.org/10.1016/j.medcli.2023.11.019Test
https://pubmed.ncbi.nlm.nih.gov/38218655Test

المؤلفون: Gonzalez-Rodriguez, Ana Pilar, López-Corral, L., Moreno Fajardo, David Fernando, Gonzalez-Huerta, Ana Julia, Palomo, Pilar, Bermúdez, Arantxa, Zudaire Ripa, Teresa, Santos-Diaz, Patricia, Gonzalez-Muñiz, Soledad, Zanabilli, Joud, Jiménez-Ubieto, Ana, Arriba, Felipe de, Arnao‐Herráiz, Mario, Sordo-Bahamonde, Christian, López-Soto, Alejandro, González, Segundo, Rosiñol, Laura, Mateos, Maria Victoria

المساهمون: Instituto de Salud Carlos III, European Commission

الوصف: This study was supported in part by the Spanish grant of Instituto de Salud Carlos III (PI16/01485) and FEDER European Union. ; Peer reviewed

العلاقة: https://doi.org/10.1038/s41409-019-0525-1Test; Sí; Bone Marrow Transplantation 55: 461-463 (2020); http://hdl.handle.net/10261/222771Test; http://dx.doi.org/10.13039/501100000780Test; http://dx.doi.org/10.13039/501100004587Test

الإتاحة: https://doi.org/10.1038/s41409-019-0525-1Test
https://doi.org/10.13039/501100000780Test
https://doi.org/10.13039/501100004587Test
http://hdl.handle.net/10261/222771Test

المؤلفون: Bastida, José María, López‐Godino, Oriana, Vicente‐Sánchez, Ana, Bonanad‐Boix, Santiago, Xicoy‐Cirici, Blanca, Hernandez-Sánchez, Jesus M., Such, Esperanza, Cervera, José, Caballero‐Berrocal, Juan C., López Cadenas, Félix, Arnao‐Herráiz, Mario, Rodríguez, Inés, Llopis‐Calatayud, Inmaculada, Jiménez, María J., Cañizo, María Consuelo del, Díez-Campelo, María

المساهمون: Centro de Investigación Biomédica en Red Cáncer (España), Instituto de Salud Carlos III

مصطلحات موضوعية: Anemia, Hemogram, Macrocytosis, Mutation analysis, Myelodysplastic syndrome

الوصف: [Introduction]: Diagnosis of myelodysplastic syndromes (MDSs) when anemia is the only abnormality can be complicated. The aim of our study was to investigate the primary causes of anemia and/or macrocytosis of uncertain etiology. [Methods]: We conducted a multicenter, prospective study over 4 months in three hematology laboratories. In step 1, we used an automated informatics system to screen 137 453 hemograms for cases of anemia and/or macrocytosis (n = 2702). In step 2, we excluded all patients whose anemia appeared to be due to a known cause. This left 290 patients had anemia of uncertain etiology. In step 3, we conducted further investigations, including a peripheral blood smear, and analysis of iron, vitamin B12, folate, and thyroid hormone levels. [Results]: A differential diagnosis was obtained in 139 patients (48%). The primary causes of anemia were iron deficiency (n = 59) and megaloblastic anemia (n = 39). In total, 25 hematologic disorders were diagnosed, including 14 patients with MDS (56%). The median age of MDS patients was 80 years, 12 had anemia as an isolated cytopenia, and most (n = 10) had lower‐risk disease (IPSS‐R ≤ 3.5). SF3B1 mutations were most frequent (n = 6) and correlated with the presence of ring sideroblasts (100%) and associated with better prognosis (P = 0.001). [Conclusions]: Our prospective, four‐step approach is an efficient and logical strategy to facilitate the diagnosis of MDS on the basis of unexplained anemia and/or macrocytosis, and may allow the early diagnosis of the most serious causes of anemia. Molecular analysis of genes related to MDS could be a promising diagnostic and prognostic approach. ; This work was also partially financed by the Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Instituto de Salud Carlos III (ISCIII) (PI 17/01741 from MDC and PI 17/01966 from JMB).

العلاقة: http://dx.doi.org/10.1111/ijlh.12933Test; Sí; International Journal of Laboratory Hematology 41(1): 109-117 (2019); http://hdl.handle.net/10261/203329Test; http://dx.doi.org/10.13039/501100004587Test

الإتاحة: https://doi.org/10.1111/ijlh.12933Test
https://doi.org/10.13039/501100004587Test
http://hdl.handle.net/10261/203329Test