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1,812 results on '"San‐Miguel, J"'

156. Corrigendum: Second primary malignancies in multiple myeloma: an overview and IMWG consensus

Author

Musto, P, Anderson, K. C, Attal, M, Richardson, P. G, Badros, A, Hou, J, Comenzo, R, Du, J, Durie, B. G. M, San Miguel, J, Einsele, H, Chen, W. M, Garderet, L, Pietrantuono, G, Hillengass, J, Kyle, R. A, Moreau, P, Lahuerta, J. J, Landgren, O, Ludwig, H, Larocca, A, Mahindra, A, Cavo, M, Mazumder, A, McCarthy, P. L, Nouel, A, Rajkumar, S. V, Reiman, A, Riva, E, Sezer, O, Terpos, E, Turesson, I, Usmani, S, Weiss, B. M, Palumbo, A., Musto, P, Anderson, K. C, Attal, M, Richardson, P. G, Badros, A, Hou, J, Comenzo, R, Du, J, Durie, B. G. M, San Miguel, J, Einsele, H, Chen, W. M, Garderet, L, Pietrantuono, G, Hillengass, J, Kyle, R. A, Moreau, P, Lahuerta, J. J, Landgren, O, Ludwig, H, Larocca, A, Mahindra, A, Cavo, M, Mazumder, A, Mccarthy, P. L, Nouel, A, Rajkumar, S. V, Reiman, A, E, Riva, Sezer, O, Terpos, E, Turesson, I, Usmani, S, Weiss, B. M, and Palumbo, A.

Subjects
NA
Abstract

Erratum to: Annals of Oncology, Volume 28, Issue 2, 1 February 2017, Pages 228–245, https://doi.org/10.1093/annonc/mdw606

Published
2018

157. Autologous peripheral blood stem cell transplantation for multiple myeloma: a report of 259 cases from the Spanish Registry

Author

Alegre, A, Díaz-Mediavilla, J, San-Miguel, J, Martínez, R, Laraña, J García, Sureda, A, Lahuerta, JJ, Morales, D, Bladé, J, Caballero, D, De la Rubia, J, Escudero, A, Díez-Martín, JL, Hernández-Navarro, F, Rifón, J, Odriozola, J, Brunet, S, De la Serna, J, Besalduch, J, Vidal, MJ, Solano, C, Leon, A, Sánchez, JJ, Martínez-Chamorro, C, and Fernández-Rañada, JM

Published
1998
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160. High-dose therapy/autologous stem cell transplantation increases complete remission rate in multiple myeloma irrespective of the induction regimen used: TD (Thalidomide/dexamethasone), VTD (bortezomib/thalidomide/dexamethasone) or VBMCP/VBAD plus bortezom: O162

Author

Rosiñol, L., Cibeira, M. T., Martínez, J., Mateos, M. V., Terol, M. J., de la Rubia, J., Palomera, L., de Arriba, F., Oriol, A., Alegre, A., Besalduch, J., de Paz, R., García-Laraña, J., Díaz-Mediavilla, J., Sureda, A., Lahuerta, J. J., San Miguel, J., and Bladé, J.

Published
2009

161. The research mission in myeloma

Author

Richardson, PG, San-Miguel, J, Lonial, S, Reece, D, Jakubowiak, A, Hussein, M, Jagannath, S, Mitsiades, CS, Raje, N, Kaufman, J, Avigan, D, Ghobrial, I, Schlossman, RL, Munshi, N, Dalton, W, and Anderson, KC

Published
2009

162. The European Myeloma Stem Cell Network (MSCNET): B552

Author

Johnsen, H E, Schmitz, A, Fogd, K B, Andersen, H, Vanderkerken, K, Valckenborgh, K, Sonneveld, E V, Duin, M V, Orfao, A, Sanz, R G, Paiva, B, Sahota, S, Pietras, D J, Weston-Bell, N, Babbage, G, Bos, N A, Fuhler, G, Klein, B, Caraux, A, Hose, D, Seckinger, A, Niklas, Z, Pfeifer, S, Schreder, M, Andres, M P, San Miguel, J, Almeida, J, Hoejfeldt, A, Hansen, A L, Dybkaer, K, Bøgsted, M, Urup, T, and Pilgaard, L

Published
2009

186. Tandem autologous transplant versus reduced-intensity conditioned allogeneic transplant in chemosensitive patients with multiple myeloma not achieving complete remission or near-CR with a first autologous transplant. Final results from a PHETEMA study

Author

Rosiñol, L., Lahuerta, J. J., Sureda, A., de la Rubia, J., García-Laraña, J., Hernández-García, M., Hernández-Ruíz, B., Pérez-Simón, J. A., Bello, J. L., Carrera, D., Peñarrubia, M. J., Abella, E., León, A., Poderós, C., García-Ruíz, J. C., Besalduch, J., Martínez-Martínez, R., Fernández-Pérez, I., Ribas, P., San Miguel, J., and Bladé, J.

Published
2008

188. Blood monitoring of circulating tumor plasma cells by next generation flow in multiple myeloma after therapy

Author

Sanoja-Flores, L., Flores-Montero, J., Puig, N., Contreras-Sanfeliciano, T., Pontes, R., Corral-Mateos, A., Garcia-Sanchez, O., Diez-Campelo, M., Magalhaes, R.J.P. de, Garcia-Martin, L., Alonso-Alonso, J.M., Garcia-Mateo, A., Aguilar-Franco, C., Labrador, J., Barez-Garcia, A., Maiolino, A., Paiva, B., San Miguel, J., Costa, E.S. da, Gonzalez, M., Mateos, M.V., Durie, B., Dongen, J.J.M. van, Orfao, A., Bitter, W.M., Lubbers, B.R., Meij, A.S.M. van der, Teodosio, C.I., Zlei, M., Sluijs-Gelling, A.J. van der, Burg, M. van der, Velden, V.H.J. van der, Langerak, A.W., Marvelde, J. te, Schilperoord-Vermeulen, J., Blijkerk, A., Heezen, K.C., Almeida, J., Vidriales, M.B., Perez-Andres, J.F.M.M., Matarraz, S., Blanco, E., Martin, L., Lecrevisse, Q., Perez-Moran, J.J., Almeida, A.M., Silva, M.G. da, Faria, T., Bruggemann, M., Ritgen, M., Szczepanowski, M., Kohlscheen, S., Steinert, A., Harbst, E., Finke, J., Asnafi, V., Lhermitte, L., Duroyon, E., Trka, J., Hrusak, O., Kalina, T., Mejstrikova, E., Novakova, M., Thurner, D., Kanderova, V., Szczepanski, T., Sedek, L., Bulsa, J., Slota, L., Kulis, J., Pedreira, C.E., Nierkens, S., Jong, A. de, Koning, A. de, Lima, M., Santos, A.H., Bottcher, S., Lange, S., Engelmann, R., Paape, D., Machka, C., Gaipa, G., Burracchi, C., Bugarin, C., Lopez-Granados, E., Molina, L.D., Vlkova, M., Nechvatalova, J., Roussel, M., Campos-Guyotat, L., Aanei, C., Burgos, L., Villamor-Casas, N., Magnano, L., Philippe, J., Bonroy, C., Denys, B., Willems, A., Breughe, P., Wolf, J. de, Sousa, A.E., Silva, S.L., Fernandez, P., Morf, D., EuroFlow Consortium, and Immunology

Subjects
Pathology, medicine.medical_specialty, medicine.diagnostic_test, business.industry, Immunology, Plasma Cells, Cell Biology, Hematology, medicine.disease, Flow Cytometry, Neoplastic Cells, Circulating, Prognosis, Biochemistry, Flow cytometry, Immunophenotyping, Text mining, Flow (mathematics), medicine, Humans, business, Multiple Myeloma, Letter to Blood, Multiple myeloma
Published
2019

189. Predicting long-term disease control in transplant-ineligible patients with multiple myeloma: impact of an MGUS-like signature

Author

Rodríguez-Otero, P., Mateos, M. V., Martínez-López, J., Hernández, M. T., Ocio, E. M., Rosiñol, L., Martínez, R., Teruel, A. I., Gutiérrez, N. C., Bargay, Joan, Bengoechea, Enrique, González, Y., Perez de Oteyza, Jaime, Gironella, Mercedes, Nuñez-Córdoba, J. M., Encinas, C., Martín, Jesús, Cabrera, Carlos, Palomera, L., De Arriba, Felipe, Cedena, María Teresa, Puig, N., Oriol, Albert, Paiva, Bruno, Bladé Creixenti, Juan, Lahuerta, J. J., San Miguel, J. F., Universitat Autònoma de Barcelona, Institut Català de la Salut, [Rodríguez-Otero P] Clínica Universidad de Navarra, Pamplona, Spain. [Mateos MV, Ocio EM] Complejo Asistencial Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca, Salamanca, Spain. [Martínez-López J] Hospital Universitario 12 de Octubre, Instituto de Investigación 12 de Octubre, Madrid, Spain. [Hernández MT] Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain. [Rosiñol L] Hospital Clinic I Provincial, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain. [Gironella M] Hospital Universitari Vall d'Hebron, Barcelona, Spain., and Vall d'Hebron Barcelona Hospital Campus

Subjects
Oncology, Male, Otros calificadores::Otros calificadores::/prevención & control [Otros calificadores], medicine.medical_specialty, MRD Negativity, humanos, Population, gammopatía monoclonal de relevancia indeterminada, mieloma múltiple, lcsh:RC254-282, Biological Factors::Biomarkers [CHEMICALS AND DRUGS], Transplant ineligible, Monoclonal Gammopathy of Undetermined Significance, Article, Persones grans, factores biológicos::biomarcadores [COMPUESTOS QUÍMICOS Y DROGAS], Other subheadings::Other subheadings::/prevention & control [Other subheadings], 03 medical and health sciences, 0302 clinical medicine, Text mining, Internal medicine, medicine, neoplasias::neoplasias por tipo histológico::neoplasias de células plasmáticas::mieloma múltiple [ENFERMEDADES], Humans, education, personas::Grupos de Edad::adulto::anciano [DENOMINACIONES DE GRUPOS], Multiple myeloma, Aged, anciano, education.field_of_study, business.industry, Mieloma múltiple - Prognosi, Neoplasms::Neoplasms by Histologic Type::Neoplasms, Plasma Cell::Multiple Myeloma [DISEASES], Hematology, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, medicine.disease, Predictive value, Disease control, Novel agents, Persons::Age Groups::Adult::Aged [NAMED GROUPS], 030220 oncology & carcinogenesis, Marcadors bioquímics, Female, business, Multiple Myeloma, 030215 immunology
Abstract

Disease control at 5 years would be a desirable endpoint for elderly multiple myeloma (MM) patients, but biomarkers predicting this are not defined. Therefore, to gain further insights in this endpoint, a population of 498 newly diagnosed transplant-ineligible patients enrolled in two Spanish trials (GEM2005MAS65 and GEM2010MAS65), has been analyzed. Among the 435 patients included in this post-hoc study, 18.6% remained alive and progression free after 5 years of treatment initiation. In these patients, overall survival (OS) rate at 10 years was 60.8% as compared with 11.8% for those progressing within the first 5 years. Hemoglobin (Hb) >= 12 g/dl (OR 2.74, p = 0.001) and MGUS-like profile (OR 4.18, p = 0.005) were the two baseline variables associated with long-term disease-free survival. Upon including depth of response (and MRD), Hb >= 12 g/dl (OR 2.27) and MGUS-like signature (OR 7.48) retained their predictive value along with MRD negativity (OR 5.18). This study shows that despite the use of novel agents, the probability of disease control at 5 years is still restricted to a small fraction (18.6%) of elderly MM patients. Since this endpoint is associated with higher rates of OS, this study provides important information about diagnostic and post-treatment biomarkers helpful in predicting the likelihood of disease control at 5 years., This study was supported by the Centro de Investigacion Biomedica en Red-Area de Oncologia-del Instituto de Salud Carlos III (CIBERONC; CB16/12/00369 and CB16/12/00377), Instituto de Salud Carlos III/Subdireccion General de Investigacion Sanitaria (FIS no. PS09/01897/01370, PI12/01761, PI12/02311, PI13/01469, PI14/01867, G03/136, CD13/00340), Asociacion Espanola Contra el Cancer (GCB120981SAN) and the European Research Council (ERC) 2015 Starting Grant (MYELOMANEXT).

Published
2019

190. Real life outcomes of patients aged >= 75 years old with acute promyelocytic leukemia: experience of the PETHEMA registry

Author

Salamero O, Mart?nez-Cuadr?n D, Sobas M, Benavente C, Vives S, De la Serna J, P?rez-Encinas M, Escoda L, Gil C, Brunet S, Ramos F, Esteve J, Amigo M, Krsnik I, Manso F, Arias J, Gonz?lez-Campos J, Serrano J, Oleksiuk J, Barrios M, Garc?a-Boyero R, Novo A, Sanz M, Montesinos P, Helbig G, Holowiecka A, Armatys A, Hawrylecka D, Golos A, Ejduk A, Majcherek M, Skret A, Czyzewska J, Grosicki S, Zarzycka E, Watek M, Piatkowska-Jakubas B, Holojda J, Pluta A, Podhorecka M, Gromek T, Guzicka E, Charlinski G, Paluszewska M, de Heredia J, Hern?ndez J, Rom?n A, de la Serna J, Negri S, Ray?n C, Fern?ndez-Calvo F, D?az-Mediavilla J, Tormo M, Olave M, Amutio E, Pedro C, Gorosquieta A, Viguria M, Zudaire M, Molero T, Sayas M, Guardia R, Rivas C, Esquembre C, Garc?a R, Alcal? A, L?pez J, Rubio V, Linares M, Ribera J, San Miguel J, Deb?n G, de la C?mara R, Molines A, Loureiro C, Allegue M, Amador L, Mart? J, Madero L, Lassaletta A, Cabezudo M, Garc?a-Larana J, Rojas R, Ortega F, Pe?arrubia M, Puente F, Lopez-Ibor B, Bergua J, Ib??ez J, S?nchez P, Font L, Guinea J, Montero A, Gonz?lez M, Mart?n G, Mart?nez J, Verdeguer A, Garc?a P, Conde E, Garc?a J, Capote F, Bueno J, Bastida P, Rubio A, Fuster J, Gonz?lez J, P?rez I, Molina J, Mateos M, Ardaiz M, Rodr?guez-Calvillo M, Poder?s C, Arn?n M, Duarte R, D?az-Morfa M, Mart?n-Chac?n E, Calvo-Villas J, Garc?a-Belmonte D, Hern?ndez-Maraver D, Miskiewicz W, PETHEMA Grp, and PALG Grp

Subjects
induction mortality in APL, APL real life outcomes, Elderly APL, APL prognostic factors, neoplasms
Abstract

Acute promyelocytic leukemia is infrequent among patients aged >= 75 years old, a population that is rarely eligible for clinical protocols. This study aims to analyze the treatment strategies and clinical outcomes of very old APL patients reported to the international PETHEMA registry. Between 1997 and 2017, among 2501 APL cases registered 120 were >= 75 years old. Treatment approaches were: AIDA regimen, 79 patients; ATRA alone, 23; 16, supportive care (SC) and 2, other strategies. Patients treated with AIDA were younger, had better ECOG and lower leukocytes. Complete remission (CR) was achieved in 65% of AIDA-group vs. 45% in the ATRA-group, being infections followed by bleeding the most frequent causes of induction death. Patients in CR after AIDA showed 3-year DFS of 73%. Our real-life series of very old APL patients provides a reference basis for future treatment strategies aiming to improve clinical outcomes in this challenging population.

Published
2019

191. Explorando la celula de origen y los programas transcripcionales patologicos en mieloma multiple (MM) y amiloidosis de cadena ligera (AL) mediante la diseccion del desarrollo de la celula plasmatica (CP) normal

Author

Alameda, D., Puig, N., Cedena, M.T., Ocio, E.M., Lecumberri, R., Labrador, J., Gonzalez, M.E., Palomera, L., Gironella, M., Cabanas, V., Casanova, M., Oriol, A., Krsnik, I., Perez-Montana, A., Martinez-Lopez, J., Mateos, M.V., Lahuerta, J.J., Prosper, F., San Miguel, J., and Paiva, B.

Abstract

CO-009 MM y AL son las dos gammapatias monoclonales malignas más comunes. Los intentos para identificar las diferencias genéticas entre ambas han tenido poco éxito. Además, se desconoce si MM y AL emergen del mismo compartimento de CPs normales. Nos proponemos definir el atlas trancripcional del desarrollo de la CP normal en sangre periférica (SP) y medula ósea (MO), y compararlo con el programa transcripcional de las CPs clonales de MM y AL. Se estudiaron 93 individuos, en 7 donantes sanos (DS), se aislaron CP de SP según su isotipo de cadena pesada (IgG, IgA and IgM). Adicionalmente, se obtuvieron 5 subpoblaciones de CP de MO basadas en la expresión de CD19, CD39, CD81 y CD56. Las CPs clonales de pacientes con MM (n=38) y AL (n=41) se separaron mediante FACS por fenotipo aberrante especifico de paciente. Para estudiar poblaciones de CP con un reducido numero de células aisladas, empleamos un método de RNAseq de alta sensibilidad (MARS-seq). Se realizaron todas las comparaciones pareadas posibles de expresión diferencial (Deseq2). Se generaron datos de expresión mediante single-cell RNAseq (scRNAseq, 10xGenomics) de un total de 35, 910 PCs de 3 HA, 2 MM and 2 AL, que fueron analizados de manera integrada con el paquete Seurat en R. ...

Published
2019

192. An analysis of the impact of CD56 expression in de novo acute promyelocytic leukemia patients treated with upfront all-trans retinoic acid and anthracycline-based regimens

Author

Sobas M, Montesinos P, Boluda B, Bernal T, Vellenga E, Nomdedeu J, Gonzalez-Campos J, Chillon M, Holowiecka A, Esteve J, Bergua J, Gonzalez-Sanmiguel J, Gil-Cortes C, Tormo M, Salamero O, Manso F, Fernandez I, de la Serna J, Moreno M, Perez-Encinas M, Krsnik I, Ribera J, Escoda L, Lowenberg B, Sanz M, de Heredia J, Hernandez J, Arias J, Ramos F, Roman A, Negri S, Rayon C, Fernandez-Calvo F, Diaz-Mediavilla J, Gil C, Olave M, Amutio E, Pedro C, Gorosquieta A, Viguria M, Zudaire M, Molero T, Sayas M, Guardia R, Esquembre C, Garcia R, Alcala A, Lopez J, Rubio V, Amigo M, Linares M, San Miguel J, Coruna A, Deben G, de la Camara R, Molines A, Loureiro C, Allegue M, Amador L, Marti J, Madero L, Lassaletta A, Cabezudo M, Garcia-Larana J, Rojas R, Ortega F, Penarrubia M, Puente F, Lopez-Ibor B, Brunet S, Ibanez J, Sanchez P, Novo A, Guinea J, Montero A, Gonzalez M, Martin G, Martinez J, Verdeguer A, Garcia P, Conde E, Garcia J, Capote F, Bueno J, Bastida P, Rubio A, Fuster J, Gonzalez J, Perez I, Molina J, Mateos M, Ardaiz M, Rodriguez-calvillo M, Poderos C, Arnan M, Duarte R, Diaz-Morfa M, Martin-Chacon E, Calvo-Villas J, Garcia-Belmonte D, Hernandez-Maraver D, Ossenkoppele G, van der Lelie J, Sonneveld P, Zijlmans M, Maertens J, de Valk B, Wijermans P, de Groot M, Schouten H, Biesma D, van Marwijk M, de Lisa E, Golos A, Ejduk A, Armatys A, Zarzycka E, Knopinska W, Miskiewicz W, Jastrzab B, Pluta A, Paluszewska M, Podhorecka M, Gromek T, Jakubas B, Majcherek M, Skret A, Watek M, Charlinski G, Calbecka M, Becht R, Gadomska A, Rzenno E, Piszcz J, Grosicki S, Palmer L, Ciarlo S, Bezares F, Rojas F, Longoni H, Gelemur M, Fazio P, Canepa C, Saba S, Balladares G, Negri P, Giunta M, Milone J, Lafalse D, Sossa C, Jaramillo F, Mayer J, Protivankova M, Scwarz J, PETHEMA Cooperative Grp, HOVON Cooperative Grp, PALG Cooperative Grp, and GATLA Cooperative Grp

Subjects
relapse, Acute promyelocytic leukemia, CD56, ATRA, chemotherapy, prognostic
Abstract

Out of 956, there were 95 (10%) CD56+ APL patients treated with PETHEMA ATRA and chemotherapy. CD56+ expression was associated with high WBC, BCR3 isoform, and co-expression of CD2, CD34, CD7, HLA-DR, CD15, and CD117 antigens. CD56+ vs CD56- APL presented higher induction death rate (16% vs 8%, p = .02) and 5-years cumulative incidence of relapse (33% versus 10%, p = .006), irrespectively of the Sanz score (low-risk 47% versus 5%, p < .001; intermediate 23% versus 7%, p < .001; and high-risk 42% versus 21%, p = .007). In the multivariate analysis, CD56 + (p < .0001), higher relapse-risk score (p = .001), and male gender (p = .05) retained the independent predictive value. CD56+ APL also showed a greater risk of CNS relapse (6% versus 1%, p < .001) and lower 5-year OS (75% versus 83%, p = .003). The AIDA-based LPA2012 trial, with an intensified consolidation schedule for CD56+ APL, will elucidate whether an intensified consolidation schedule could mitigate the relapse rate in this setting.

Published
2019

193. Carfilzomib or bortezomib with melphalan-prednisone for transplant-ineligible patients with newly diagnosed multiple myeloma

Author

Facon, T. Lee, J.H. Moreau, P. Niesvizky, R. Dimopoulos, M. Hajek, R. Pour, L. Jurczyszyn, A. Qiu, L. Klippel, Z. Zahlten-Kumeli, A. Osman, M. Paiva, B. San-Miguel, J.

Abstract

The phase 3 CLARION study compared carfilzomib-melphalan-prednisone (KMP) with bortezomib-melphalan-prednisone (VMP) in transplant-ineligible newly diagnosed multiple myeloma (NDMM) patients. Patients were randomized 1:1 to KMP or VMP for nine 42-day cycles (C). Patients received carfilzomib on days (D) 1, 2, 8, 9, 22, 23, 29, 30 (20 mg/m2: C1D1, C1D2; 36mg/m2 there after) or bortezomibon D1, 4, 8, 11, 22, 25, 29, 32 (1.3 mg/m2; D4, 11, 25, 32 omitted for C5-9). Melphalan (9 mg/m2) and prednisone (60 mg/m2) were administered on D1-4. The primary endpoint was progression-free survival (PFS). Nine hundred fifty-five patients were randomized (intention-to-treat population: KMP, n 5 478; VMP, n 5 477). Median PFS was 22.3 months with KMP vs 22.1 months with VMP (hazard ratio [HR], 0.906; 95% confidence interval [CI], 0.746-1.101; P 5. 159). Median overall survival was similar and not reached in either group (HR, 1.08; 95% CI, 0.82-1.43). Overall response rate was 84.3% for KMP and 78.8% for VMP. Complete response rate was 25.9% for KMP and 23.1% for VMP. Minimal residual disease-negative rates were 15.7% (KMP) and 15.5% (VMP). Adverse events (AEs) of interest (any grade) occurring with a ≥5% higher patient incidence in the KMP arm were acute renal failure (13.9% [KMP] vs 6.2% [VMP]) and cardiac failure (10.8% vs 4.3%). Grade ≥3 AE rates were 74.7% (KMP) and 76.2% (VMP). Grade ≥2 peripheral neuropathy was lower for KMP vs VMP (2.5% vs 35.1%). Treatment with KMP in CLARION did not yield a statistically significant difference in PFS vs VMP. © 2019 by The American Society of Hematology.

Published
2019

194. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial

Author

Richardson, P.G. Oriol, A. Beksac, M. Liberati, A.M. Galli, M. Schjesvold, F. Lindsay, J. Weisel, K. White, D. Facon, T. San Miguel, J. Sunami, K. O'Gorman, P. Sonneveld, P. Robak, P. Semochkin, S. Schey, S. Yu, X. Doerr, T. Bensmaine, A. Biyukov, T. Peluso, T. Zaki, M. Anderson, K. Dimopoulos, M. Abildgaard, N. Adler, H. Altuntas, F. Akay, O.M. Amin, B. Anagnostopoulos, A. Anderson, L. Anttila, P. Araujo, C. Arce-Lara, C. Aydin, Y. Basu, S. Battini, R. Beeker, T. Benboubker, L. Ben-Yehuda, D. Bladé, J. Blau, I.W. Boccia, R. Burke, L. Byeff, P. Cascavilla, N. Cavo, M. Chantry, A. Charles, Y. Chaudhry, A. Corso, A. Coyne, M. De Arriba, F. Delimpasi, S. Desjardins, P. Dhakal, B. Di Bartolomeo, P. Di Raimondo, F. Dürig, J. Engelhardt, M. Escoffre-Barbe, M. Esteves, G. Flogegard, M. Gabrail, N. Gamberi, B. Garrison, M. Gay, J. Gisslinger, H. Goldschmidt, H. Goncalves, C. Gressot, L. Grosicki, S. Hanna, W. Hayden, P. Henriques Bernardo, M.M. Hermann, R. Holden, V. Honkalehto, K. Huben, M. Huffman, J. Hunter, H. Hus, M. Jagasia, M. Jagganath, S. Janakiram, M. Jaiyesimi, I. Jenner, M. João, C. Johnson, P. Jurcyszyn, A. Kalayoğlu Beşişik, S. Kambhampati, S. Kanate, A. Karadoğan, I. Khojasteh, A. Kirkel, D. Komarnicki, M. Krauth, M.-T. Kuriakose, P. Larocca, A. Lauri, B. Leleu, X. Lucio, P. Luppi, M. Mangiacavalli, S. Mariette, C. Matsue, K. Mellqvist, U.-H. Mendeleeva, L. Meshad, M. Miller, C. Mohrbacher, A. Moreau, P. Morelli, A.M. Müldür, E. Naassan, A. Nahi, H. Nair, R. O'Dwyer, M. Öngören Aydin, S. Openshaw, T. O'Rourke, T. Osswald, M. Overton, L. Pati, A. Pavic, M. Pegourie, B. Pehlivan, M. Pierola, A.A. Plesner, T. Pluta, A. Rabin, N. Ramasamy, K. Rambaldi, A. Rodriguez, P. Röllig, C. Rosenblatt, J. Rosenbluth, J. Salomo, M. Samoylova, O. Sastre Moral, J. Sati, H. Selleri, C. Shafeek, S. Shinagawa, A. Sleckman, B. Smith, C. Sonmez, M. Stone, C. Streetly, M. Suzuki, K. Taetle, R. Tafuri, A. Takezako, N. Teke, H.Ü. Vapaatalo, M. Vassilopoulos, G. Verma, A. Vidito, S. Viterbo, L. Vural, F. Wang, X.S. Yağci, M. Yee, A. OPTIMISMM trial investigators

Subjects
hemic and lymphatic diseases
Abstract

Background: As lenalidomide becomes increasingly established for upfront treatment of multiple myeloma, patients refractory to this drug represent a population with an unmet need. The combination of pomalidomide, bortezomib, and dexamethasone has shown promising results in phase 1/2 trials of patients with relapsed or refractory multiple myeloma. We aimed to assess the efficacy and safety of this triplet regimen in patients with relapsed or refractory multiple myeloma who previously received lenalidomide. Methods: We did a randomised, open-label, phase 3 trial at 133 hospitals and research centres in 21 countries. We enrolled patients (aged ≥18 years)with a diagnosis of multiple myeloma and measurable disease, an Eastern Cooperative Oncology Group performance status of 0–2, who received one to three previous regimens, including a lenalidomide-containing regimen for at least two consecutive cycles. We randomly assigned patients (1:1)to bortezomib and dexamethasone with or without pomalidomide using a permutated blocked design in blocks of four, stratified according to age, number of previous regimens, and concentration of β2 microglobulin at screening. Bortezomib (1·3 mg/m2)was administered intravenously until protocol amendment 1 then either intravenously or subcutaneously on days 1, 4, 8, and 11 for the first eight cycles and subsequently on days 1 and 8. Dexamethasone (20 mg [10 mg if age >75 years])was administered orally on the same days as bortezomib and the day after. Patients allocated pomalidomide received 4 mg orally on days 1–14. Treatment cycles were every 21 days. The primary endpoint was progression-free survival in the intention-to-treat population, as assessed by an independent review committee. Safety was assessed in all patients who received at least one dose of study medication. This trial is registered at ClinicalTrials.gov, number NCT01734928; patients are no longer being enrolled. Findings: Between Jan 7, 2013, and May 15, 2017, 559 patients were enrolled. 281 patients were assigned pomalidomide, bortezomib, and dexamethasone and 278 were allocated bortezomib and dexamethasone. Median follow-up was 15·9 months (IQR 9·9–21·7). Pomalidomide, bortezomib, and dexamethasone significantly improved progression-free survival compared with bortezomib and dexamethasone (median 11·20 months [95% CI 9·66–13·73]vs 7·10 months [5·88–8·48]; hazard ratio 0·61, 95% CI 0·49–0·77; p

Published
2019

198. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study

Author

Attal, M. Richardson, P.G. Rajkumar, S.V. San-Miguel, J. Beksac, M. Spicka, I. Leleu, X. Schjesvold, F. Moreau, P. Dimopoulos, M.A. Huang, J.S.-Y. Minarik, J. Cavo, M. Prince, H.M. Macé, S. Corzo, K.P. Campana, F. Le-Guennec, S. Dubin, F. Anderson, K.C. Richardson, P.G. Rajkumar, V. Dimopoulos, M.A. Corzo, K.P. Harrison, S. Janowski, W. Kerridge, I. Spencer, A. Delforge, M. Fostier, K. Vlummens, P. Wu, K.L. Leblanc, R. Pavic, M. Sebag, M. Hajek, R. Maisnar, V. Pour, L. Gregersen, H. Benbouker, L. Caillot, D. Escoffre-Barbe, M. Facon, T. Frenzel, L. Hulin, C. Karlin, L. Kolb, B. Pegourie, B. Perrot, A. Tiab, M. Vincent, L. Niederwieser, D. Anagnostopoulos, A. Delimpasi, S. Kyrtsonis, M.-C. Symeonidis, A. Illes, A. Mikala, G. Nagy, Z. Bringen, S. Corradini, P. Fabio, C. Lemoli, R. Liberati, A. Nozzoli, C. Zambello, R. Iida, S. Ikeda, T. Iyama, S. Matsumoto, M. Shimazaki, C. Sunami, K. Suzuki, K. Uchiyama, M. Koh, Y. Kim, K. Lee, J.H. Min, C.-K. Blacklock, H. Goodman, H. Neylon, A. Simpson, D. Grosicki, S. Jurczyszyn, A. Walter-Croneck, A. Warzocha, K. Araujo, L. Moreira, C. Doronin, V. Mendeleeva, L. Vorobyev, V. Vranovsky, A. Alegre, A. Gironella, M. Gonzalez Perez, M.S. Montes, C. Ocio, E. Rodriguez, P. Hardling, M. Lauri, B. Wang, M.-C. Yeh, S.-P. Arat, M. Demirkan, F. Gulbas, Z. Besisik, S.K. Karadogan, I. Tuglular, T. Unal, A. Vural, F. Sive, J. Streetly, M. Yong, K. Tache, J.

Abstract

Background: Isatuximab is a monoclonal antibody that binds a specific epitope on the human CD38 receptor and has antitumour activity via multiple mechanisms of action. In a previous phase 1b study, around 65% of patients with relapsed and refractory multiple myeloma achieved an overall response with a combination of isatuximab with pomalidomide and low-dose dexamethasone. The aim of this study was to determine the progression-free survival benefit of isatuximab plus pomalidomide and dexamethasone compared with pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma. Methods: We did a randomised, multicentre, open-label, phase 3 study at 102 hospitals in 24 countries in Europe, North America, and the Asia-Pacific regions. Eligible participants were adult patients with relapsed and refractory multiple myeloma who had received at least two previous lines of treatment, including lenalidomide and a proteasome inhibitor. Patients were excluded if they were refractory to previous treatment with an anti-CD38 monoclonal antibody. We randomly assigned patients (1:1) to either isatuximab 10 mg/kg plus pomalidomide 4 mg plus dexamethasone 40 mg (20 mg for patients aged ≥75 years), or pomalidomide 4 mg plus dexamethasone 40 mg. Randomisation was done using interactive response technology and stratified according to the number of previous lines of treatment (2–3 vs >3) and age (

Published
2019

199. Clinical significance of complex karyotype at diagnosis in pediatric and adult patients with de novo acute promyelocytic leukemia treated with ATRA and chemotherapy

Author

Labrador J, Luno E, Vellenga E, Brunet S, Gonzalez-Campose J, Chillon M, Holowiecka A, Esteve J, Bergua J, Gonzalez-Sanmiguel J, Gil C, Tormo M, Salamero O, Manso F, Fernandez I, de laSerna J, Moreno M, Perez-Encinas M, Krsnik I, Ribera J, Cervera J, Calasanz M, Boluda B, Sobas M, Lowenberg B, Sanz M, Montesinos P, Palmer L, Ciarlo S, Bezares F, Rojas F, Longoni H, Gelemur M, Fazio P, Canepa C, Saba S, Balladares G, Negri P, Giunta M, Milone J, Prates M, Lafalse D, Sossa C, Jaramillo F, Mayer J, Protivankova M, Scwarz J, Holowiecka-Goral A, Jakubas B, Skret-Norwicz A, Bizgalska-Skrzypek P, Pluta A, Becht R, Kielbinski M, Watek M, Paluszewska M, Gadomska A, Rzenno E, Piszcz J, Ejduk A, Dobrzanska J, Calbecka M, Kostyra A, Malek M, Grosicki S, Knopinska W, Beltran de Heredia J, Hernandez J, Arias J, Ramos F, Roman A, de la Serna J, Negri S, Rayon C, Fernandez-Calvo F, Diaz-Mediavilla J, Olave M, Amutio E, Pedro C, Gorosquieta A, Viguria M, Zudaire M, Molero T, Sayas M, Guardia R, Rivas C, Esquembre C, Garcia R, Alcala A, Lopez J, Rubio V, Amigo M, Linares M, Gonzalez San Miguel J, Deben G, Escoda L, de la Camara R, Molines A, Loureiro C, Allegue M, Amador L, Marti J, Madero L, Lassaletta A, Cabezudo M, Garcia-Larana J, Rojas R, Ortega F, Penarrubia M, Puente F, Lopez-Ibor B, Ibanez J, Sanchez P, Novo A, Font L, Guinea J, Montero A, Gonzalez M, Martin G, Martinez J, Verdeguer A, Garcia P, Conde E, Garcia J, Capote F, Bueno J, Bastida P, Rubio A, Fuster J, Gonzalez J, Perez I, Molina J, Mateos M, Ardaiz M, Rodriguez-calvillo M, Poderos C, Arnan M, Duarte R, Diaz-Morfa M, Martin-Chacon E, Calvo-Villas J, Garcia-Belmonte D, Hernandez-Maraver D, Ossenkoppele G, van der Lelie J, Sonneveld P, Zijlmans M, Maertens J, de Valk B, Wijermans P, de Groot M, Schouten H, Biesma D, Kooy M, de Lisa E, PETHEMA Grp, HOVON Grp, PALG Grp, and GATLA Grp

Subjects
relapse, complex karyotype, Acute promyelocytic leukemia, ATRA, chemotherapy, prognostic
Abstract

Although additional cytogenetic abnormalities (ACA) do not affect the prognosis of patients with t(15;17) acute promyelocytic leukemia (APL), the role of a complex karyotype (CK) is yet to be clarified. We aimed to investigate the relationship of CK with relapse incidence in 1559 consecutive APL patients enrolled in three consecutive trials. Treatment consisted of AIDA induction followed by risk-adapted consolidation. A CK (CK) was defined as the presence of >= 2 ACA, and a very CK (CK+) as >= 3 ACA. Eighty-nine patients (8%) had a CK, of whom 41 (4%) had CK+. The 5-year cumulative incidence of relapse (CIR) in patients with CK was 18%, and 12% in those with

Published
2019

200. Bortezomib, lenalidomide, and dexamethasone as induction therapy prior to autologous transplantation in multiple myeloma

Author

Rosiñol L, Oriol A, Rios R, Sureda A, Blanchard MJ, Hernández MT, Martínez-Martínez R, Moraleda JM, Jarque I, Bargay J, Gironella M, de Arriba F, Palomera L, Gonzalez-Montes Y, Marti J, Krsnik I, Arguiñano JM, Gonzalez ME, Gonzalez AP, Casado LF, Lopez-Anglada L, Paiva B, Mateos MV, San Miguel J, Lahuerta JJ, and Bladé J

Abstract

Achieving and maintaining high-quality response is the treatment goal for patients with newly diagnosed multiple myeloma (NDMM). The phase 3 PETHEMA/GEM2012 study, in 458 patients {less than or equal to} 65 years old with NDMM, is evaluating bortezomib (subcutaneous) + lenalidomide + dexamethasone (VRD) for 6 cycles followed by autologous stem cell transplant (ASCT) conditioned with intravenous busulfan + melphalan vs melphalan and posttransplant consolidation with 2 cycles of VRD. We present grouped response analysis of induction, transplant, and consolidation. Responses deepened over time; in patients who initiated cycle 6 of induction (n = 426), the {greater than or equal to} very good partial response rates were 55.6% by cycle 3, 63.8% by cycle 4, 68.3% by cycle 5, and 70.4% after induction. The complete response rate of 33.4% after induction in the intent-to-treat (ITT) population, which was similar in the 92 patients with high-risk cytogenetics (34.8%), also deepened with further treatment (44.1% after ASCT and 50.2% after consolidation). Rates of undetectable minimal residual disease (median 3 10 -6 sensitivity) in the ITT population also increased from induction (28.8%) to transplant (42.1%) and consolidation (45.2%). The most common grade {greater than or equal to} 3 treatment-emergent adverse events during induction were neutropenia (12.9%) and infection (9.2%). Grade {greater than or equal to} 2 peripheral neuropathy (grouped term) during induction was 17.0%, with a low frequency of grade 3 (3.7%) and grade 4 (0.2%) events. VRD is an effective and well-tolerated regimen for induction in NDMM with deepening response throughout induction and over the course of treatment. This trial was registered at ClinicalTrials.gov (NCT01916252) and EudraCT (2012-005683-10).

Published
2019

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