المؤلفون: Ríos-Tamayo, Rafael, Soler, Juan Alfons, García-Sánchez, Ricarda, Pérez Persona, Ernesto, Arnao, Mario, García-Guiñón, Antoni, Domingo, Abel, González-Pardo, Miriam, de la Rubia Comos, Javier, Mateos, Maria-Victoria, GeminiS Study Investigators

مصطلحات موضوعية: Relapsed-refractory multiple myeloma, Real-world, Monoclonal antibodies, Daratumumab, Standard of care, 32 Ciencias Médicas

الوصف: The aim of this study is 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 study was sponsored by Janssen-Cilag. Janssen-Cilag participated in the study design, data analysis and drafting of the manuscript. All investigators received financial com- pensation for their participation in the study. ; Medicina

العلاقة: http://hdl.handle.net/20.500.12466/4403Test

الإتاحة: https://doi.org/20.500.12466/440310.1080/16078454.2023.2178997Test
https://hdl.handle.net/20.500.12466/4403Test

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: Puig, Noemi, Hernández, Miguel T., Rosiñol, Laura, González, Esther, Arriba, Felipe de, Oriol, Albert, González-Calle, Verónica, Escalante, Fernando, Rubia, Javier de la, Gironella, Mercedes, Ríos, Rafael, García-Sánchez, Ricarda, Arguiñano, José M., Alegre, Adrián, Martín, Jesús, Gutiérrez, Norma. C. Gutiérrez, Calasanz, María J., Martín, María L., Couto, María del Carmen, Ocio San Miguel, Enrique María

المساهمون: Universidad de Cantabria

المصدر: Blood Cancer J . 2021 May 21;11(5):101

الوصف: 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: https://doi.org/10.1038/s41408-021-00490-8Test; http://hdl.handle.net/10902/23826Test

الإتاحة: https://doi.org/10.1038/s41408-021-00490-8Test
http://hdl.handle.net/10902/23826Test

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: Maia, Catarina, Puig, Noemí, Cedena, Maria-Teresa, Gutiérrez, Norma, Calassanz, María-J, Martín-Ramos, Maria-L, Garcia, Miguel Teodoro Hernandez, Rosiñol, Laura, González, Mª Esther, de la Fuente, Felipe de Arriba, Oriol, Albert, González, Verónica, Escalante, Fernando, De la Rubia, Javier, Mesa, Mercedes Gironella, Ríos, Rafael, García-Sánchez, Ricarda, Arguiñano, José-M, Alegre, Adrián, San-Miguel, Jesus, Palacios, Juan José Lahuerta, Blade, Joan, Niesvizky, Ruben, Mateos, María-Victoria, Paiva, Bruno

المصدر: Clinical Lymphoma Myeloma and Leukemia ; volume 22, page S84-S85 ; ISSN 2152-2650

مصطلحات موضوعية: Cancer Research, Oncology, Hematology

الإتاحة: https://doi.org/10.1016/s2152-2650Test(22)00420-7
https://api.elsevier.com/content/article/PII:S2152265022004207?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S2152265022004207?httpAccept=text/plainTest

المؤلفون: Askari, Elham, Moreno, David F., Escalante, Fernando, Domingo-González, Amalia, Heredia, Angela, Bermúdez, Arancha, Canales, Miguel, Herraiz, Mario Arnao, Alcala Peña, Maria Magdalena, Saus Carreres, Ana, Ríos Rull, Pablo, Casanova, María, Gironella, Mercedes, Ribas Garcia, Paz, De La Rubia, Javier, Navarro, Belén, Blanchard, María-Jesús, Motlló, Cristina, García Sánchez, Ricarda, Taboada Alameda, Francisco, Garcia, Antonio, Abella, Eugenio, Alvarez Rivas, Miguel Angel, Bargay, Joan, Sabater, Laura Abril, Lopez Picado, Amanda, Fernández de Larrea, Carlos, Garcia-Sanz, Ramon

المصدر: Blood; November 2023, Vol. 142 Issue: 1, Number 1 Supplement 1 p4406-4406, 1p

مستخلص: Introduction

المؤلفون: Ramirez, Gemma, García-Sanchez, Ricarda, Plaza, Sylvia

المصدر: Medicina Clínica ; volume 140, issue 6, page 278-282 ; ISSN 0025-7753

مصطلحات موضوعية: General Medicine

الإتاحة: https://doi.org/10.1016/j.medcli.2012.10.007Test
https://api.elsevier.com/content/article/PII:S0025775312008810?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S0025775312008810?httpAccept=text/plainTest

المؤلفون: Calvo-Villas, José M., Alegre, Adrián, Calle, Carmen, Hernández, Miguel T., García-Sánchez, Ricarda, Ramírez, Gema

المصدر: European Journal of Haematology ; volume 87, issue 3, page 281-284 ; ISSN 0902-4441

الإتاحة: https://doi.org/10.1111/j.1600-0609.2011.01644.xTest

المؤلفون: Manuel Calvo-Villas, Jose, Alegre, Adrian, García-Sánchez, Ricarda, Hernández, Miguel T, Giraldo, Pilar, Zudaire, Maite, Gusmao, Bremo, Rodríguez, Juan N, Calle, Carmen, Ramirez, Gemma, Iñigo, Belen, Martinez, Joaquin, Oriol, Albert

المصدر: Blood; November 2009, Vol. 114 Issue: 22 p4952-4952, 1p

مستخلص: Current clinical observations on extramedullary myeloma (EM) are based on small series of relapsed myeloma patients (pts) and, in this situation, results suggest that the disease course is often aggressive. Among novel therapies for extramedullary involvement, thalidomide has provided poor results and bortezomib is emerging as a possible useful drug. The role of lenalidomide for treatment of multiple myeloma (MM) with EM is still under investigation.A multicenter retrospective study was performed by PETHEMA (Spanish Myeloma Group, Spain) to evaluate the response rate and toxicity profile of lenalidomide-based regimens in myeloma patients with extramedullary involvement at relapse or progression. All the cases were evaluated for response of MM and improvement of extramedullary plasmacytoma.From October 2007 to March 2009, thirteen patients (median age 67 years; range 61–87; 7 females) treated with lenalidomide-containing regimens were recorded. Patients with bone disease without extramedullary manifestations were excluded. Response of MM was evaluated according to the new international criteria and the response of EM by measuring size changes by physical examination, CT scans and/or MR imaging. Adverse events were graded based on the WHO toxicity scale. The M-protein type was IgG in 7 cases, IgA in 5 and light chain in 1. The type of light chain was κ in 7 pts and l in 6. In eight patients the soft-tissue plasmacytomas may have developed from underlying bone lesions [(skull (n=2), rib cage (n=4) and paravertebral (n=2)], two patients had subcutaneous nodules and three had visceral involvement (liver (n=1), lung and kidney (n=1) and pleura (n=1). Multiple localizations were present in 4 pts (30.7%). Six cases (79.6%) received previous antimyeloma treatment for EM before lenalidomide therapy and the incidence of prior bone plasmacytomas was 61.5%. Median time from initial antimyeloma therapy to treatment with lenalidomide was 34 months (range 5 - 115). Median number of prior lines of chemotherapy regimens was 3 (range 1 – 4), including autologous stem cell transplantation in 2 pts, bortezomib-containing regimens in 12 (92.3%) and previous exposure to thalidomide in 1 patient. Ten pts received standard lenalidomide dose (25 mg/day every 4 weeks) plus dexamethasone (40 mg/d PO ranging from 1 to 12 doses/cycle) every 3-week; and three patients received lower doses of lenalidomide and/or different schedules. Involved-field radiotherapy was given in 2 cases. Thirty percent of patients required lenalidomide dose reduction, because of toxicity or intolerance.Median duration of lenalidomide treatment was 3.6 months (1 – 15). One case was not evaluable for response because of death from disease progression after one cycle. In nine out of twelve evaluable patients (75%), MM responded to lenalidomide regimens according to EBMT criteria. Three (25%) achieved complete response, five (41.6%) partial response and 1 (8.3%) minimal response. Median time to response was 63 days (range 37 – 180). Regarding EM, nine patients showed response in the size of extramedullary plasmacytomas. Seven (58.3%) achieved complete disappearance of EM and two pts reduction of the size. Response of EM was also achieved in 75% of pts previously exposed to bortezomib, and in 4/9 cases who received therapies for prior extramedullary involvement. Median follow-up period was 6.3 months (1 – 15.8). Median overall survival from the start of lenalidomide therapy was 4.7 months. At the time of analysis, seven patients were still on therapy, and ten (76.9%) were alive. Only one out of the 9 patients who had achieved a response has relapsed so far. Toxicity profile (grade 3/4) was: thrombocytopenia, 4 (30.7%); anemia, 2 (15.3%); neutropenia, 5 (46.4%); neutropenic fever, 1 (7.6%) and others, 3 (11.8%). No deep venous thrombosis (DVT) was reported. Thrombosis prophylaxis was used in most cases (92%) patients.We report one of the first investigations specifically evaluating the activity of lenalidomide on EM. Lenalidomide-containing regimens could be an alternative promising approach to achieve clinical response in heavily treated MM patients with extramedullary disease. The duration of response and the best regimen or combination are at present unknown. These preliminary observations require further analysis and longer follow-up.No relevant conflicts of interest to declare.