المؤلفون: Wong, Sandy W., Bar, Noffar, Victoria Mateos, María, Ribas, Paz, Hansson, Markus, Paris, Laura, Hofmeister, Craig, Rodriguez-Otero, Paula, Aranzazu Bermúdez, Maria, Santoro, Armando, Yee, Andrew J., Creignou, Maria, Encinas, Cristina, Cerchione, Claudio, de la Rubia, Javier, Oriol, Albert, Ferstl, Barbara, Besemer, Britta, Chen, Jinjie, Chung, Alexander, Boss, Isaac W., Gaudy, Allison, LI, Shaoyi, Hsu, Kevin, Godwin, Colin, Burgess, Michael R., San-Miguel, Jesús, Jose Costa, Luciano

المصدر: HemaSphere ; volume 7, issue S3, page e1220745 ; ISSN 2572-9241

الإتاحة: https://doi.org/10.1097/01.hs9.0000970436.12207.45Test

المؤلفون: Gonzalez-Calle, Veronica, Rodríguez-Otero, Paula, Sureda, Anna, de la Fuente, Felipe de Arriba, Reinoso Segura, Marta, Ribas, Paz, Pilar Gonzalez, Ana, Gonzalez Montes, Yolanda, Oriol, Albert, Martinez-Lopez, Joaquín, Perez, Marta Sonia Gonzalez, Garcia, Miguel Teodoro Hernandez, Sirvent Auzmendi, Maialen, Blade, Joan, Palacios, Juan José Lahuerta, San Miguel, Jesús, Mateos, Maria-Victoria

المصدر: HemaSphere ; volume 7, issue S3, page e954902c ; ISSN 2572-9241

الإتاحة: https://doi.org/10.1097/01.hs9.0000970416.95490.2cTest

المؤلفون: Mateos, Maria-Victoria, Rodriguez Otero, Paula, Koh, Youngil, Martinez-Lopez, Joaquin, Parmar, Gurdeep, Prince, H. Miles, Quach, Hang, Ribas, Paz, Hermansen, Emil, Hungria, Vania T. M., Kalayoğlu Beşışık, Sevgi, Kim, Jin Seok, Leleu, Xavier, Peceliunas, Valdas, Schjesvold, Fredrik, Sevindik, Ömür Gökmen, Lavrova, Tatiana, Dubin, Franck, Devisme, Christine, Lepine, Lucie, Ghobrial, Irene

مصطلحات موضوعية: 3 Ithaca Study, High-Risk Smoldering Multiple Myeloma, Dexamethasone, Lenalidomide

الوصف: Background: Results from a randomized, Phase 3 study by the Spanish Myeloma Group (PETHEMA/GEM) previously showed that treatment with lenalidomide plus dexamethasone (Rd) may delay progression to active disease in patients (pts) with high-risk smoldering multiple myeloma (SMM), compared with observation. To further improve outcomes, addition of the anti-CD38 antibody isatuximab (Isa) to lenalidomide and dexamethasone (Isa-Rd) for the treatment of pts with high-risk SMM is being evaluated in the ongoing, randomized, multi-center, Phase 3 ITHACA study (NCT04270409). Initial findings from the safety run-in analysis of this trial have shown a manageable safety profile and encouraging, preliminary anti-myeloma activity. We now report updated safety and efficacy results from the safety run-in part of ITHACA at a median follow-up of 19.4 months. Methods: Pts were included in the study if they had been diagnosed within 5 years with SMM (per the International Myeloma Working Group [IMWG] criteria) and had high-risk SMM according to the Mayo '20-2-20' and/or updated PETHEMA model criteria. Pts who had received prior anti-myeloma treatment were not eligible. Enrolled pts received Isa 10 mg/kg IV on day (D) 1, 8, 15, and 22 in cycle (C) 1, D1 and D15 C2-12, D1 C13-36; plus R D1-21 (25 mg C1-9; 10 mg C10-24) and d weekly (40 mg, 20 mg for ≥75 yr-old pts C1-9; 20 mg C10-24). Cycle duration was 28 days. Safety evaluations included treatment-emergent AEs (TEAEs)/serious AEs and laboratory parameters, graded by NCI-CTCAE v5.0. Response was determined by IMWG criteria (2016). Mandatory imaging by MRI and/or low-dose whole-body CT/PET-CT, and assessments of minimal residual disease (MRD, by next-generation sequencing in pts with very good partial response [VGPR] or better), were performed at protocol-defined time points. The primary study objective for the safety run-in was to confirm the recommended dose of Isa in combination with Rd. Overall response rate (ORR) and MRD negativity rate at 10-5 sensitivity were included as ...

وصف الملف: application/pdf

العلاقة: Blood; Konferans Öğesi - Uluslararası - Kurum Öğretim Elemanı; Mateos, M.-V., Rodriguez Otero, P., Koh, Y., Martinez-Lopez, J., Parmar, G., Prince, H. M. . Ghobrial, I. (2022). Isatuximab in combination with lenalidomide and dexamethasone in patients with high-risk smoldering multiple myeloma: Updated safety run-in results from the randomized phase 3 ithaca study. American Society of Hematology içinde (7317-7319. ss.). https://dx.doi.org/10.1182/blood-2022-157302Test; https://dx.doi.org/10.1182/blood-2022-157302Test; https://hdl.handle.net/20.500.12511/10630Test; 140; Supplement: 1; 7317; 7319; Q1; 000893230300143

الإتاحة: https://doi.org/20.500.12511/10630Test
https://doi.org/10.1182/blood-2022-157302Test
https://hdl.handle.net/20.500.12511/10630Test

المؤلفون: Costa, Luciano, Bar, Noffar, Mateos, Maria-Victoria, Ribas, Paz, Hansson, Markus, Paris, Laura, Hofmeister, Craig, Rodriguez-Otero, Paula, Bermúdez, Maria Aranzazu, Santoro, Armando, Yee, Andrew, Creignou, Maria, Encinas, Cristina, Cerchione, Claudio, de la Rubia, Javier, Oriol, Albert, Ferstl, Barbara, Besemer, Britta, Chen, Jinjie, Boss, Isaac, Gaudy, Allison, Hsu, Kevin, Godwin, Colin, San-Miguel, Jesús, Wong, Sandy

المصدر: Clinical Lymphoma Myeloma and Leukemia ; volume 23, page S52-S53 ; ISSN 2152-2650

مصطلحات موضوعية: Cancer Research, Oncology, Hematology

الإتاحة: https://doi.org/10.1016/s2152-2650Test(23)01652-x
https://api.elsevier.com/content/article/PII:S215226502301652X?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S215226502301652X?httpAccept=text/plainTest

المؤلفون: Cejalvo, María J, Legarda, Mario, Abella, Eugenia, Cabezudo, Elena, Encinas, Cristina, García-Feria, Ana, Gironella, Mercedes, Iñigo, Belén, Martín, Jesús, Ribas, Paz, Ruíz, Mª Ángeles, González, Yolanda, Vicuña, Isabel, Ramírez, Ángel, Fernández, Pascual, de la Rubia, Javier

مصطلحات موضوعية: daratumumab, dialysis, multiple myeloma, relapse, Aged, Antibodies, Monoclonal, Disease-Free Survival, Female, Humans, Male, Middle Aged, Recurrence, Renal Dialysis, Retrospective Studies, Survival Rate

العلاقة: http://hdl.handle.net/10668/14782Test

الإتاحة: https://doi.org/10.1111/bjh.16286Test
http://hdl.handle.net/10668/14782Test

المؤلفون: Rodriguez-Otero, Paula, Sirvent, Maialen, González-Rodríguez, Ana Pilar, Lavilla, Esperanza, de Coca, Alfonso García, Arguiñano, José María, Martí, Josep M., Cabañas, Valentin, Motlló, Cristina, de Cabo, Erik, Encinas, Cristina, Murillo, Ilda, Hernández-Rivas, Jose Ángel, Pérez-Persona, Ernesto, Casado, Felipe, Sampol, Antonia, García, Ricarda, Blanchard, María Jesús, Anguita, Magdalena, Lafuente, Ana Paz, Iñigo, Belén, López, Aurelio, Ribas, Paz, Arnao, Mario, Maldonado, Roberto, Bladé, Joan, Mateos, María Victoria, Lahuerta, Juan José, San Miguel, Jesús F.

المصدر: Clinical Lymphoma Myeloma and Leukemia ; volume 21, issue 6, page 413-420 ; ISSN 2152-2650

مصطلحات موضوعية: Cancer Research, Oncology, Hematology

الإتاحة: https://doi.org/10.1016/j.clml.2021.02.004Test
https://api.elsevier.com/content/article/PII:S2152265021000653?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S2152265021000653?httpAccept=text/plainTest

المؤلفون: Garcia-Guiñón, Antonio, Morales, Enrique, Sureda, A, González-García, Esther, Durán, María Soledad, Escalante, Fernando, Gironella, M, González-López, Tomás José, Duro, Rafael, Encinas, Manuel Pérez, Ribas, Paz, Cabezudo, Elena, García, Rafael Lluch, Español, Ignacio, Cabanas, Valentín, García-Muñoz, Ricardo, Márquez, José Antonio, Navarro, Mireya, de la Rubia, Javier

المصدر: Clinical Lymphoma Myeloma and Leukemia ; volume 21, page S97-S98 ; ISSN 2152-2650

مصطلحات موضوعية: Cancer Research, Oncology, Hematology

الإتاحة: https://doi.org/10.1016/s2152-2650Test(21)02242-4
https://api.elsevier.com/content/article/PII:S2152265021022424?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S2152265021022424?httpAccept=text/plainTest

المؤلفون: Carreras, Enric, Rosiñol, Laura, Terol, Maria José, Alegre, Adrián, de Arriba, Felipe, García-Laraña, José, Bello, José Luis, García, Raimundo, León, Angel, Martínez, Rafael, Peñarrubia, M. Jesús, Poderós, Concha, Ribas, Paz, Ribera, Josep Maria, San Miguel, Jesús, Bladé, Joan, Lahuerta, Juan José

المصدر: Biology of Blood and Marrow Transplantation ; volume 13, issue 12, page 1448-1454 ; ISSN 1083-8791

مصطلحات موضوعية: Transplantation, Hematology

الإتاحة: https://doi.org/10.1016/j.bbmt.2007.08.002Test
https://api.elsevier.com/content/article/PII:S1083879107003795?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S1083879107003795?httpAccept=text/plainTest

المؤلفون: Mateos Manteca, María Victoria, Hernández, José M., Hernández, Miguel T., Gutiérrez Gutiérrez, Norma Carmen, Palomera, Luis, Fuertes, M., Díaz-Mediavilla, Joaquín, Lahuerta, Juan José, De la Rubia, Javier, Terol, María-José, Sureda, Anna, Bargay, Joan, Ribas, Paz, De Arriba, Felipe, Alegre, Adrian, Oriol, Albert, Carrera, Dolores, García-Laraña, José, García Sanz, Ramón, Bladé, Joan, Prósper, Felipe, Mateo, Gemma, Esseltine, Dixie-Lee, van de Velde, Helgi, San Miguel Izquierdo, Jesús Fernando

مصطلحات موضوعية: Mieloma múltiple, Disease-Free Survival, Immunophenotyping, Aged, Boronic Acids, Humans, Pyrazines, Melphalan, Antineoplastic Combined Chemotherapy Protocols, Antineoplastic Agents, Multiple Myeloma, Maximum Tolerated Dose, Cohort Studies, Prednisone, protocolos de quimioterapia antineoplásica combinada, humanos, anciano, supervivencia sin enfermedad, prednisona, inmunofenotipificación, ácidos borónicos, dosis máxima tolerada, estudios de cohortes, antineoplásicos, piracinas, melfalán

الوصف: [EN]Standard first-line treatment for elderly multiple myeloma (MM) patients ineligible for stem cell transplantation is melphalan plus prednisone (MP). However, complete responses (CRs) are rare. Bortezomib is active in patients with relapsed MM, including elderly patients. This phase 1/2 trial in 60 untreated MM patients aged at least 65 years (half older than 75 years) was designed to determine dosing, safety, and efficacy of bortezomib plus MP (VMP). VMP response rate was 89%, including 32% immunofixation-negative CRs, of whom half of the IF- CR patients analyzed achieved immunophenotypic remission (no detectable plasma cells at 10(-4) to 10(-5) sensitivity). VMP appeared to overcome the poor prognosis conferred by retinoblastoma gene deletion and IgH translocations. Results compare favorably with our historical control data for MP--notably, response rate (89% versus 42%), event-free survival at 16 months (83% versus 51%), and survival at 16 months (90% versus 62%). Side effects were predictable and manageable; principal toxicities were hematologic, gastrointestinal, and peripheral neuropathy and were more evident during early cycles and in patients aged 75 years or more. In conclusion, in elderly patients ineligible for transplantation, the combination of bortezomib plus MP appears significantly superior to MP, producing very high CR rates, including immunophenotypic CRs, even in patients with poor prognostic features.

العلاقة: https://doi.org/10.1182/blood-2006-04-019778Test; Mateos, M. V., Hernández, J. M., Hernández, M. T., Gutiérrez, N. C., Palomera, L., Fuertes, M., . & Miguel, J. F. S. (2006). Bortezomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma: results of a multicenter phase 1/2 study. Blood, 108(7), 2165-2172. https://doi.org/10.1182/blood-2006-04-019778Test; http://hdl.handle.net/10366/154234Test

الإتاحة: https://doi.org/10.1182/blood-2006-04-019778Test
http://hdl.handle.net/10366/154234Test

المؤلفون: Blanes, Margarita, Lorenzo, Jose Ignacio, Ribas, Paz, Jiménez, Ana, González, José David, Cejalvo, María José, Solano, Carlos, Alegre, Adrian, Rubia, Javier de la

المصدر: Clinical Lymphoma Myeloma and Leukemia ; volume 19, issue 10, page e287-e288 ; ISSN 2152-2650

مصطلحات موضوعية: Cancer Research, Oncology, Hematology

الإتاحة: https://doi.org/10.1016/j.clml.2019.09.473Test
https://api.elsevier.com/content/article/PII:S2152265019318609?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S2152265019318609?httpAccept=text/plainTest