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1. Pomalidomide, Cyclophosphamide, and Dexamethasone for the Treatment of Relapsed/ Refractory Multiple Myeloma: Real-World Analysis of the Pethema-GEM Experience

Author

Rodriguez-Otero P, Sirvent M, González-Rodríguez AP, Lavilla E, de Coca AG, Arguiñano JM, Martí JM, Cabañas V, Motlló C, de Cabo E, Encinas C, Murillo I, Hernández-Rivas JÁ, Pérez-Persona E, Casado F, Sampol A, García R, Blanchard MJ, Anguita M, Lafuente AP, Iñigo B, López A, Ribas P, Arnao M, Maldonado R, Bladé J, Mateos MV, Lahuerta JJ, and San Miguel JF

Subjects
Refractory multiple myeloma, Triplet therapy, Pomalidomide, Real-world study, Lenalidomide-refractoriness
Abstract

Treatment of relapsed/refractory multiple myeloma (RRMM) is highly challenging. We analyzed the efficacy and safety of pomalidomide, cyclophosphamide, and dexamethasone (PomCiDex) in a real-world RRMM population. Median progression-free and overall survival were 7.6 and 12.6 months, respectively, which compares favorably with other triplets in the same setting. PomCiDex remains a manageable, cost-effective, and all-oral triplet combination for RRMM. Introduction: Treatment of relapsed/refractory multiple myeloma (RRMM) is highly challenging, especially for patients with disease refractory to initial therapy, and in particular for disease developing refractoriness to lenalidomide. Indeed, with currently approved treatments, median progression-free survival (PFS) in the lenalidomide-refractory setting is less than 10 months, reflecting the difficulty in treating this patient population. Pomalidomide is a second-generation immunomodulatory drug that has shown activity in lenalidomide-refractory disease in the setting of different combinations. Patients and Methods: A real-world study was conducted by the Spanish Myeloma group in a cohort of patients with RRMM treated with pomalidomide, cyclophosphamide, and dexamethasone (PomCiDex). One hundred patients were treated with a median of 3 prior lines of therapy. Results: Overall response rate was 39%, with a clinical benefit rate of 93%. Median PFS was 7.6 months; median overall survival (OS) was 12.6 months. Median PFS and OS survival were consistent across the different subgroups analyzed. Prolonged PFS and OS were found in patients with responsive disease. Conclusion: Our results compared favorably with those obtained with different pomalidomide-based combinations in a similar patient population. PomCiDex remains a manageable, cost-effective, and all-oral triplet combination for RRMM patients. (C) 2021 Published by Elsevier Inc.

Published
2021

2. Multiple myeloma and SARS-CoV-2 infection: clinical characteristics and prognostic factors of inpatient mortality

Author

Martínez-López, Joaquín, Mateos, M. V., Encinas, C., Sureda, A., Hernández-Rivas, J. Á., Lopez de la Guía, A., Conde, D., Krsnik, I., Prieto, E., Riaza Grau, R., Gironella, Mercedes, Blanchard, M. J., Caminos, N., Fernández de Larrea, C., Senin, Alicia., Escalante, F., de la Puerta, J. E., Giménez, E., Martínez-Barranco, P., Mateos, J. J., Casado Montero, Luis Felipe, Bladé, J., Lahuerta, J. J., De la Cruz, Javier, San-Miguel, J., Universitat Autònoma de Barcelona, Martínez-López, Joaquín, Mateos, Maria Victoria, Lahuerta, Juan José, San-Miguel, Jesús, Martínez-López, Joaquín [0000-0001-7908-0063], Mateos, Maria Victoria [0000-0003-2390-1218], Lahuerta, Juan José [0000-0002-3393-9570], San-Miguel, Jesús [0000-0002-9183-4857], Institut Català de la Salut, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Male, Multivariate analysis, Epidemiology, Myeloma, Disease, Comorbidity, técnicas de investigación::métodos epidemiológicos::recopilación de datos::estadísticas vitales::mortalidad [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Kidney, COVID-19 (Malaltia), Severity of Illness Index, 0302 clinical medicine, Multiple myeloma, virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES], Neoplasms::Neoplasms by Histologic Type::Neoplasms, Plasma Cell::Multiple Myeloma [DISEASES], Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES], Hematology, Middle Aged, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Prognosis, Hospitalization, Oncology, 030220 oncology & carcinogenesis, Cohort, Investigative Techniques::Epidemiologic Methods::Data Collection::Vital Statistics::Mortality [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Infectious diseases, Female, Drug therapy, Coronavirus Infections, Multiple Myeloma, medicine.medical_specialty, Pronòstic mèdic, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Pneumonia, Viral, lcsh:RC254-282, Article, 03 medical and health sciences, Betacoronavirus, Pharmacotherapy, Internal medicine, Severity of illness, Mortalitat, medicine, neoplasias::neoplasias por tipo histológico::neoplasias de células plasmáticas::mieloma múltiple [ENFERMEDADES], Humans, Pandemics, Aged, Inpatients, Inpatient mortality, business.industry, SARS-CoV-2, Mieloma múltiple, COVID-19, medicine.disease, Pneumonia, Increased risk, business, 030215 immunology
Abstract

There is limited information on the characteristics, prognostic factors, and outcomes of patients with multiple myeloma (MM) hospitalized with COVID-19. This retrospective case series investigated 167 patients reported from 73 hospitals within the Spanish Myeloma Collaborative Group network in March and April, 2020. Outcomes were compared with 167 randomly selected, contemporary, age-/sex-matched noncancer patients with COVID-19 admitted at six participating hospitals. Among MM and noncancer patients, median age was 71 years, and 57% of patients were male; 75 and 77% of patients, respectively, had at least one comorbidity. COVID-19 clinical severity was moderate–severe in 77 and 89% of patients and critical in 8 and 4%, respectively. Supplemental oxygen was required by 47 and 55% of MM and noncancer patients, respectively, and 21%/9% vs 8%/6% required noninvasive/invasive ventilation. Inpatient mortality was 34 and 23% in MM and noncancer patients, respectively. Among MM patients, inpatient mortality was 41% in males, 42% in patients aged >65 years, 49% in patients with active/progressive MM at hospitalization, and 59% in patients with comorbid renal disease at hospitalization, which were independent prognostic factors on adjusted multivariate analysis. This case series demonstrates the increased risk and identifies predictors of inpatient mortality among MM patients hospitalized with COVID-19.

Published
2020

4. 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

5. Early myeloma-related death in elderly patients: development of a clinical prognostic score and evaluation of response sustainability role (vol 32, pg 2427, 2018)

Author

Rodriguez-Otero P, Mateos M, Martinez-Lopez J, Martin-Calvo N, Hernandez M, Ocio E, Rosinol L, Martinez R, Teruel A, Gutierrez N, Bargay J, Bengoechea E, Gonzalez Y, de Oteyza J, Gironella M, Encinas C, Martin J, Cabrera C, Palomera L, de Arriba F, Cedena M, Paiva B, Puig N, Oriol A, Blade J, Lahuerta J, and San Miguel J

Published
2019

6. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial

Author

Dimopoulos, M.A. Gay, F. Schjesvold, F. Beksac, M. Hajek, R. Weisel, K.C. Goldschmidt, H. Maisnar, V. Moreau, P. Min, C.K. Pluta, A. Chng, W.-J. Kaiser, M. Zweegman, S. Mateos, M.-V. Spencer, A. Iida, S. Morgan, G. Suryanarayan, K. Teng, Z. Skacel, T. Palumbo, A. Dash, A.B. Gupta, N. Labotka, R. Rajkumar, S.V. Bar, D. Basso, A. Fantl, D. He, S. Horvath, N. Lee, C. Rowlings, P. Taylor, K. Cochrane, T. Kwok, F. Ramanathan, S. Agis, H. Zojer, N. Kentos, A. Offner, F. Van Droogenbroeck, J. Wu, K.L. Maiolino, A. Martinez, G. Zanella, K. Capra, M. Araújo, S. Gregora, E. Pour, L. Scudla, V. Spicka, I. Abildgaard, N. Andersen, N. Jensen, B.A. Helleberg, C. Plesner, T. Salomo, M. Svirskaite, A. Delarue, R. Blau, I. Schieferdecker, A. Teleanu, V. Munder, M. Röllig, C. Salwender, H.-J. Fuhrmann, S. Weisel, K. Duerig, J. Zeis, M. Klein, S. Reimer, P. Schmidt, C. Scheid, C. Mayer, K. Hoffmann, M. Sosada, M. Dimopoulos, A. Delimpasi, S. Kyrtsonis, M.-C. Anagnostopoulos, A. Nagy, Z. Illés, Á. Egyed, M. Borbényi, Z. Mikala, G. Dally, N. Horowitz, N. Gutwein, O. Nemets, A. Vaxman, I. Shvetz, O. Trestman, S. Ruchlemer, R. Nagler, A. Tadmor, T. Rouvio, O. Preis, M. Cavo, M. De Rosa, L. Musto, P. Cafro, A. Tosi, P. Offidani, M. Corso, A. Rossi, G. Liberati, A.M. Bosi, A. Suzuki, K. Nakaseko, C. Ishikawa, T. Matsumoto, M. Nagai, H. Sunami, K. Chou, T. Akashi, K. Takezako, N. Hagiwara, S. Eom, H.S. Jo, D.-Y. Kim, J.S. Lee, J.H. Yoon, S.S. Yoon, D.H. Kim, K. Levin, M.-D. Vellenga, E. Minnema, M. Waage, A. Haukås, E. Grosicki, S. Pluta, A. Robak, T. Marques, H. Bergantim, R. Campilho, F. Chng, W.J. Goh, Y.T. McDonald, A. Rapoport, B. Álvarez Rivas, M.A. De Arriba de La Fuente, F. González Montes, Y. Martin Sanchez, J. Mateos, M.V. Oriol Rocafiguera, A. Rosinol, L. San Miguel, J. Pérez de Oteyza, J. Encinas, C. Alegre-Amor, A. López-Guía, A. Axelsson, P. Carlson, K. Stromberg, O. Hansson, M. Hveding Blimark, C. Mueller, R. Chen, C.-C. Liu, T.-C. Huang, S.-Y. Wang, P.-N. Na Nakorn, T. Prayongratana, K. Unal, A. Goker, H. Sonmez, M. Korenkova, S. Chaidos, A. Oakervee, H. Sati, H. Benjamin, R. Wechalekar, A. Garg, M. Ramasamy, K. Cook, G. Chantry, A. Jenner, M. Buadi, F. Berryman, R. Janakiram, M. TOURMALINE-MM3 study group

Abstract

Background: Maintenance therapy following autologous stem cell transplantation (ASCT) can delay disease progression and prolong survival in patients with multiple myeloma. Ixazomib is ideally suited for maintenance therapy given its convenient once-weekly oral dosing and low toxicity profile. In this study, we aimed to determine the safety and efficacy of ixazomib as maintenance therapy following ASCT. Methods: The phase 3, double-blind, placebo-controlled TOURMALINE-MM3 study took place in 167 clinical or hospital sites in 30 countries in Europe, the Middle East, Africa, Asia, and North and South America. Eligible participants were adults with a confirmed diagnosis of symptomatic multiple myeloma according to International Myeloma Working Group criteria who had achieved at least a partial response after undergoing standard-of-care induction therapy followed by high-dose melphalan (200 mg/m2) conditioning and single ASCT within 12 months of diagnosis. Patients were randomly assigned in a 3:2 ratio to oral ixazomib or matching placebo on days 1, 8, and 15 in 28-day cycles for 2 years following induction, high-dose therapy, and transplantation. The initial 3 mg dose was increased to 4 mg from cycle 5 if tolerated during cycles 1–4. Randomisation was stratified by induction regimen, pre-induction disease stage, and response post-transplantation. The primary endpoint was progression-free survival (PFS) by intention-to-treat analysis. Safety was assessed in all patients who received at least one dose of ixazomib or placebo, according to treatment actually received. This trial is registered with ClinicalTrials.gov, number NCT02181413, and follow-up is ongoing. Findings: Between July 31, 2014, and March 14, 2016, 656 patients were enrolled and randomly assigned to receive ixazomib maintenance therapy (n=395) or placebo (n=261). With a median follow-up of 31 months (IQR 27·3–35·7), we observed a 28% reduction in the risk of progression or death with ixazomib versus placebo (median PFS 26·5 months [95% CI 23·7–33·8] vs 21·3 months [18·0–24·7]; hazard ratio 0·72, 95% CI 0·58–0·89; p=0·0023). No increase in second malignancies was noted with ixazomib therapy (12 [3%] patients) compared with placebo (eight [3%] patients) at the time of this analysis. 108 (27%) of 394 patients in the ixazomib group and 51 (20%) of 259 patients in the placebo group experienced serious adverse events. During the treatment period, one patient died in the ixazomib group and none died in the placebo group. Interpretation: Ixazomib maintenance prolongs PFS and represents an additional option for post-transplant maintenance therapy in patients with newly diagnosed multiple myeloma. Funding: Millennium Pharmaceuticals, a wholly owned subsidiary of Takeda Pharmaceutical Company. © 2019 Elsevier Ltd

Published
2019

7. Minimal residual disease monitoring and immune profiling using second generation flow cytometry in elderly multiple myeloma

Author

Paiva, B. (Bruno), Cedena, M.T. (María Teresa), Puig, N. (Noemí), Arana, P. (Paula), Vidriales, M.B. (María Belén), Cordón, L. (Lourdes), Flores-Montero, J. (Juan), Gutierrez, N.C. (Norma C.), Martin-Ramos, M.L. (Maria Luisa), Martínez-López, J. (Joaquín), Ocio, E.M. (Enrique M.), Hernandez, M.T. (Miguel Teodoro), Teruel, A.I. (Ana Isabel), Rosiñol, L. (Laura), Echeveste, M.A. (Maria Asuncion), Martínez, R. (Rafael), Gironella, M. (Mercedes), Oriol, A. (Albert), Cabrera, C. (Carmen), Martin, J. (Jesus), Bargay, J. (Joan), Encinas, C. (Cristina), Gonzalez, Y. (Yolanda), Dongen, J.J.M. (Jacques J. M.) van, Orfao, A. (Alberto), Bladé, J. (Joan), Mateos, M.V. (María Victoria), Lahuerta, J.J. (Juan José), and San-Miguel, J.F. (Jesús F.)

Subjects
body regions, hemic and lymphatic diseases, Ciencias de la Salud::Hematología [Materias Investigacion]
Abstract

The value of minimal residual disease (MRD) in multiple myeloma (MM) has been more frequently investigated in transplant-eligible than elderly patients. Since an optimal balance between treatment efficacy and toxicity is of utmost importance in elderly MM, sensitive MRD monitoring might be particularly valuable in this patient population. Here, we used 2nd generation 8-color multiparameter-flow-cytometry (MFC) to monitor MRD in 162 transplant-ineligible MM patients enrolled in the PETHEMA/GEM2010MAS65 study, The transition from 1st to 2nd generation MFC resulted in increased sensitivity, and allowed to identify three patient groups according to MRD levels: MRD-negative (75-years (HR:4.8; P

Published
2016

10. Optimizing the use of Erythropoietin-Receptor stimulating Agents (ERAs) in patients with hematopoietic malignancies based on the level of reticulocyte hemoglobin | Optimización del uso de Agentes estimulantes del Receptor de la Eritropoyetina (AREs) en pacientes con neoplasias hematológicas basado en el nivel de hemoglobina reticulocitaria

Author

Armellini, A., Marcos Gonzalez Díaz, Martín, J. S., Vidriales, M. B., Encinas, C., Caballero, M. D., Arcos, M. J., Colado, E., Arroyo, M. E., Martín, J., Gutiérrez, N., Olazábal, J., Vásquez, L., Hernández Rivas, J. M., González Díaz, M., San Miguel, J. F., and García-Sanz, R.

11. Optimizing the use of Erythropoietin-Receptor stimulating Agents (ERAs) in patients with hematopoietic malignancies based on the level of reticulocyte hemoglobin,Optimización del uso de Agentes estimulantes del Receptor de la Eritropoyetina (AREs) en pacientes con neoplasias hematológicas basado en el nivel de hemoglobina reticulocitaria

Author

Armellini, A., García Marcos, M. A., Martín, J. S., Vidriales, M. B., Encinas, C., Caballero, M. D., Arcos, M. J., Colado, E., Arroyo, M. E., Martín, J., Gutiérrez, N., Olazábal, J., Vásquez, L., Hernández Rivas, J. M., González Díaz, M., San Miguel, J. F., and Ramon Garcia-Sanz

12. PREDICTORS OF EARLY DEATH RELATED TO ACTIVE MULTIPLE MYELOMA IN ELDERLY PATIENTS RECEIVING OPTIMIZED FRONTLINE TREATMENT COMBINATIONS

Author

Rodriguez Otero, P., Mateos, M. V., Joaquin, M. -L, Miguel Teodoro, H., Enrique M, O., Rosinol, L., Martinez, R., Teruel, A. -I, Gutierrez, N. C., Oriol, A., Martin-Calvo, N., Paiva, B., Bargay, J., Bengoechea, E., Gonzalez, Y., Perez Oteyza, J., Gironella, M., Encinas, C., Martin, J., Cabrera, C., Palomera, L., Arriba, F., Cedena, M. T., Puig, N., Blade, J., Juan José Lahuerta, and San Miguel, J. F.

13. The Current Role of the Heavy/Light Chain Assay in the Diagnosis, Prognosis and Monitoring of Multiple Myeloma: An Evidence-Based Approach

Author

Ríos-Tamayo, Rafael, Puig, Noemí, Algarín, Macarena, García de Veas Silva, José Luís, Barbosa, Nuno, Encinas, Cristina, Hernández, José Ángel, Alonso, Rafael, Campos, María Luisa, Rodríguez, Teresa, Leivas, Alberto, Olivares, María José, Sánchez, María José, Paiva, Bruno, Lahuerta, Juan José, Martínez-López, Joaquín, [Ríos-Tamayo,R] Hematology Department, Hospital Universitario Virgen de las Nieves, Granada, Spain. [Ríos-Tamayo,R, Sánchez,MJ] Instituto de Investigación Biosanitaria de Granada (Ibs.GRANADA), Granada, Spain. [Ríos-Tamayo,R, Sánchez,MJ] Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain. [Puig,N] Hematology Department, Hospital Universitario de Salamanca (HUSAL), IBSAL, IBMCC (USAL-CSIC) CIBERONC, Salamanca, Spain. [Algarín,M, Barbosa,N, Campos,ML, Leivas,A] Scientific Department, The Binding Site Iberia, Barcelona, Spain. [García de Veas Silva,JL] Molecular Diagnosis Laboratory Department, Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Encinas,C] Hematology Department, Hospital General Universitario Gregorio Marañón, IiGM, Madrid, Spain. [Hernández,JÁ] Hematology Department, Hospital Universitario Infanta Leonor, Madrid, Spain. [Alonso,R, Martínez-López,J] Hematology Department, Hospital Universitario 12 de Octubre, Madrid, Spain. [Rodríguez,T, Olivares,MJ] Immunology Department, Hospital Universitario Virgen de las Nieves, Granada, Spain. [Sánchez,MJ] Registro de Cáncer de Granada, Escuela Andaluza de Salud Pública (EASP), Granada, Spain. [Sánchez,MJ] Department of Preventive Medicine and Public Health, University of Granada, Granada, Spain. [Paiva,B] Clínica Universidad de Navarra, CIMA, CIBERONC, IDISNA, Pamplona, Spain. [Lahuerta,JJ, and Martínez-López,J] Instituto de Investigación del Hospital Universitario 12 de Octubre, Madrid, Spain.

Subjects
Cadenas ligeras de inmunoglobulina, Monitoring, Hevylite, Diagnóstico, Diseases::Hemic and Lymphatic Diseases::Hematologic Diseases::Blood Protein Disorders::Paraproteinemias [Medical Subject Headings], Mieloma múltiple, Pronóstico, Cadenas pesadas de inmunoglobulina, Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Globulins::Serum Globulins::Immunoglobulins::Immunoglobulin Subunits::Immunoglobulin Light Chains [Medical Subject Headings], Prognosis, Heavy/light chain assay, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Procesamiento automatizado de datos, Multiple myeloma, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis [Medical Subject Headings], Diagnosis, Diseases::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Plasma Cell [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis [Medical Subject Headings], Inmunoensayo, Monitorización del ambiente, Diseases::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Plasma Cell::Multiple Myeloma [Medical Subject Headings]
Abstract

Despite tremendous progress being made in recent years, multiple myeloma (MM) remains a challenging disease. The laboratory plays a critical role in the overall management of patients. The diagnosis, prognosis, clinical monitoring and evaluation of the response are key moments in the clinical care process. Conventional laboratory methods have been and continue to be the basis of laboratory testing in monoclonal gammopathies, along with the serum free light chain test. However, more accurate methods are needed to achieve new and more stringent clinical goals. The heavy/light chain assay is a relatively new test which can overcome some of the limitations of the conventional methods for the evaluation of intact immunoglobulin MM patients. Here, we report an update of the evidence accumulated in recent years on this method regarding its use in MM. Yes

Published
2021

14. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial

Author

Meletios A Dimopoulos, Francesca Gay, Fredrik Schjesvold, Meral Beksac, Roman Hajek, Katja Christina Weisel, Hartmut Goldschmidt, Vladimir Maisnar, Philippe Moreau, Chang Ki Min, Agnieszka Pluta, Wee-Joo Chng, Martin Kaiser, Sonja Zweegman, Maria-Victoria Mateos, Andrew Spencer, Shinsuke Iida, Gareth Morgan, Kaveri Suryanarayan, Zhaoyang Teng, Tomas Skacel, Antonio Palumbo, Ajeeta B Dash, Neeraj Gupta, Richard Labotka, S Vincent Rajkumar, Daniel Bar, Alfredo Basso, Dorotea Fantl, Simon He, Neomi Horvath, Cindy Lee, Phillip Rowlings, Kerry Taylor, Tara Cochrane, Fiona Kwok, Sundreswran Ramanathan, Hermine Agis, Niklas Zojer, Alain Kentos, Fritz Offner, Jan Van Droogenbroeck, Ka Lung Wu, Angelo Maiolino, Gracia Martinez, Karla Zanella, Marcelo Capra, Sérgio Araújo, Evzen Gregora, Ludek Pour, Vlastimil Scudla, Ivan Spicka, Niels Abildgaard, Niels Andersen, Bo Amdi Jensen, Carsten Helleberg, Torben Plesner, Morten Salomo, Asta Svirskaite, Richard Delarue, Igor Blau, Aneta Schieferdecker, Veronica Teleanu, Markus Munder, Christoph Röllig, Han-Juergen Salwender, Stephan Fuhrmann, Katja Weisel, Jan Duerig, Matthias Zeis, Stefan Klein, Peter Reimer, Christian Schmidt, Christof Scheid, Karin Mayer, Martin Hoffmann, Markus Sosada, Athanasios Dimopoulos, Sosana Delimpasi, Mary-Christine Kyrtsonis, Achilleas Anagnostopoulos, Zsolt Nagy, Árpád Illés, Miklós Egyed, Zita Borbényi, Gabor Mikala, Najib Dally, Netanel Horowitz, Odit Gutwein, Anatoly Nemets, Iuliana Vaxman, Olga Shvetz, Svetlana Trestman, Rosa Ruchlemer, Arnon Nagler, Tamar Tadmor, Ory Rouvio, Meir Preis, Michele Cavo, Luca De Rosa, Pellegrino Musto, Anna Cafro, Patrizia Tosi, Massimo Offidani, Alessandro Corso, Giuseppe Rossi, Anna Marina Liberati, Alberto Bosi, Kenshi Suzuki, Chiaki Nakaseko, Takayuki Ishikawa, Morio Matsumoto, Hirokazu Nagai, Kazutaka Sunami, Takaaki Chou, Koichi Akashi, Naoki Takezako, Shotaro Hagiwara, Hyeon Seok Eom, Deog-Yeon Jo, Jin Seok Kim, Jae Hoon Lee, Sung Soo Yoon, Dok Hyun Yoon, Kihyun Kim, Mark-David Levin, Edo Vellenga, Monique Minnema, Anders Waage, Einar Haukås, Sebastian Grosicki, Andrzej Pluta, Tadeusz Robak, Herlander Marques, Rui Bergantim, Fernando Campilho, Wee Joo Chng, Yeow Tee Goh, Andrew McDonald, Bernado Rapoport, Miguel Angel Álvarez Rivas, Felipe De Arriba de La Fuente, Yolanda González Montes, Jesus Martin Sanchez, Maria Victoria Mateos, Albert Oriol Rocafiguera, Laura Rosinol, Jesús San Miguel, Jaime Pérez de Oteyza, Cristina Encinas, Adrian Alegre-Amor, Ana López-Guía, Per Axelsson, Kristina Carlson, Olga Stromberg, Markus Hansson, Cecile Hveding Blimark, Rouven Mueller, Chih-Cheng Chen, Ta-Chih Liu, Shang-Yi Huang, Po-Nan Wang, Thanyaphong Na Nakorn, Kannadit Prayongratana, Ali Unal, Hakan Goker, Mehmet Sonmez, Sybiryna Korenkova, Aristeidis Chaidos, Heather Oakervee, Hamdi Sati, Reuben Benjamin, Ashutosh Wechalekar, Mamta Garg, Karthik Ramasamy, Gordon Cook, Andrew Chantry, Matthew Jenner, Francis Buadi, Robert Berryman, Murali Janakiram, Takeda Pharmaceutical Company, Dimopoulos MA1, Gay F2, Schjesvold F3, Beksac M4, Hajek R5, Weisel KC6, Goldschmidt H7, Maisnar V8, Moreau P9, Min CK10, Pluta A11, Chng WJ12, Kaiser M13, Zweegman S14, Mateos MV15, Spencer A16, Iida S17, Morgan G18, Suryanarayan K19, Teng Z19, Skacel T19, Palumbo A20, Dash AB19, Gupta N19, Labotka R19, Rajkumar SV21, TOURMALINE-MM3 study group. Bar D, Basso A, Fantl D, He S, Horvath N, Lee C, Rowlings P, Taylor K, Spencer A, Cochrane T, Kwok F, Ramanathan S, Agis H, Zojer N, Kentos A, Offner F, Van Droogenbroeck J, Wu KL, Maiolino A, Martinez G, Zanella K, Capra M, Araújo S, Gregora E, Hajek R, Maisnar V, Pour L, Scudla V, Spicka I, Abildgaard N, Andersen N, Jensen BA, Helleberg C, Plesner T, Salomo M, Svirskaite A, Delarue R, Moreau P, Blau I, Goldschmidt H, Schieferdecker A, Teleanu V, Munder M, Röllig C, Salwender HJ, Fuhrmann S, Weisel K, Duerig J, Zeis M, Klein S, Reimer P, Schmidt C, Scheid C, Mayer K, Hoffmann M, Sosada M, Dimopoulos A, Delimpasi S, Kyrtsonis MC, Anagnostopoulos A, Nagy Z, Illés Á, Egyed M, Borbényi Z, Mikala G, Dally N, Horowitz N, Gutwein O, Nemets A, Vaxman I, Shvetz O, Trestman S, Ruchlemer R, Nagler A, Tadmor T, Rouvio O, Preis M, Gay F, Cavo M, De Rosa L, Musto P, Cafro A, Tosi P, Offidani M, Corso A, Rossi G, Liberati AM, Bosi A, Suzuki K, Iida S, Nakaseko C, Ishikawa T, Matsumoto M, Nagai H, Sunami K, Chou T, Akashi K, Takezako N, Hagiwara S, Eom HS, Jo DY, Kim JS, Lee JH, Min CK, Yoon SS, Yoon DH, Kim K, Zweegman S, Levin MD, Vellenga E, Minnema M, Schjesvold F, Waage A, Haukås E, Grosicki S, Pluta A, Robak T, Marques H, Bergantim R, Campilho F, Chng WJ, Goh YT, McDonald A, Rapoport B, Álvarez Rivas MA, De Arriba de La Fuente F, González Montes Y, Martin Sanchez J, Mateos MV, Oriol Rocafiguera A, Rosinol L, San Miguel J, Pérez de Oteyza J, Encinas C, Alegre-Amor A, López-Guía A, Axelsson P, Carlson K, Stromberg O, Hansson M, Hveding Blimark C, Mueller R, Chen CC, Liu TC, Huang SY, Wang PN, Na Nakorn T, Prayongratana K, Beksac M, Unal A, Goker H, Sonmez M, Korenkova S, Chaidos A, Oakervee H, Sati H, Benjamin R, Wechalekar A, Garg M, Kaiser M, Ramasamy K, Cook G, Chantry A, Jenner M, Buadi F, Berryman R, Janakiram M., Guided Treatment in Optimal Selected Cancer Patients (GUTS), Stem Cell Aging Leukemia and Lymphoma (SALL), CCA - Cancer Treatment and quality of life, CCA - Imaging and biomarkers, CCA - Cancer biology and immunology, and Hematology

Subjects
Male, Time Factors, DIAGNOSED MULTIPLE-MYELOMA, Clinical Trial, Phase III, Administration, Oral, 030204 cardiovascular system & hematology, Ixazomib, chemistry.chemical_compound, 0302 clinical medicine, Autologous stem-cell transplantation, Maintenance therapy, Clinical endpoint, 030212 general & internal medicine, Non-U.S. Gov't, Boron Compounds/administration & dosage, IMPROVES SURVIVAL, INDUCTION, Research Support, Non-U.S. Gov't, General Medicine, CHEMOTHERAPY, Middle Aged, Clinical Trial, DEXAMETHASONE, Antineoplastic Agents/administration & dosage, Multicenter Study, Treatment Outcome, Administration, Randomized Controlled Trial, Disease Progression, Female, Multiple Myeloma, Autologous, Boron Compounds, Oral, medicine.medical_specialty, Glycine, Multiple Myeloma/drug therapy, BORTEZOMIB, Antineoplastic Agents, Placebo, Research Support, Transplantation, Autologous, 03 medical and health sciences, Phase III, Double-Blind Method, Internal medicine, medicine, Journal Article, Humans, THALIDOMIDE, Transplantation, business.industry, Clinical trial, LENALIDOMIDE MAINTENANCE, Regimen, chemistry, autologous stem cell transplantation, multiple myeloma, Ixazomib, business, HIGH-DOSE THERAPY, Glycine/administration & dosage, Stem Cell Transplantation
Abstract

[Background]: Maintenance therapy following autologous stem cell transplantation (ASCT) can delay disease progression and prolong survival in patients with multiple myeloma. Ixazomib is ideally suited for maintenance therapy given its convenient once-weekly oral dosing and low toxicity profile. In this study, we aimed to determine the safety and efficacy of ixazomib as maintenance therapy following ASCT. [Methods]: The phase 3, double-blind, placebo-controlled TOURMALINE-MM3 study took place in 167 clinical or hospital sites in 30 countries in Europe, the Middle East, Africa, Asia, and North and South America. Eligible participants were adults with a confirmed diagnosis of symptomatic multiple myeloma according to International Myeloma Working Group criteria who had achieved at least a partial response after undergoing standard-of-care induction therapy followed by high-dose melphalan (200 mg/m²) conditioning and single ASCT within 12 months of diagnosis. Patients were randomly assigned in a 3:2 ratio to oral ixazomib or matching placebo on days 1, 8, and 15 in 28-day cycles for 2 years following induction, high-dose therapy, and transplantation. The initial 3 mg dose was increased to 4 mg from cycle 5 if tolerated during cycles 1–4. Randomisation was stratified by induction regimen, pre-induction disease stage, and response post-transplantation. The primary endpoint was progression-free survival (PFS) by intention-to-treat analysis. Safety was assessed in all patients who received at least one dose of ixazomib or placebo, according to treatment actually received. This trial is registered with ClinicalTrials.gov, number NCT02181413, and follow-up is ongoing. [Findings]: Between July 31, 2014, and March 14, 2016, 656 patients were enrolled and randomly assigned to receive ixazomib maintenance therapy (n=395) or placebo (n=261). With a median follow-up of 31 months (IQR 27·3–35·7), we observed a 28% reduction in the risk of progression or death with ixazomib versus placebo (median PFS 26·5 months [95% CI 23·7–33·8] vs 21·3 months [18·0–24·7]; hazard ratio 0·72, 95% CI 0·58–0·89; p=0·0023). No increase in second malignancies was noted with ixazomib therapy (12 [3%] patients) compared with placebo (eight [3%] patients) at the time of this analysis. 108 (27%) of 394 patients in the ixazomib group and 51 (20%) of 259 patients in the placebo group experienced serious adverse events. During the treatment period, one patient died in the ixazomib group and none died in the placebo group. [Interpretation]: Ixazomib maintenance prolongs PFS and represents an additional option for post-transplant maintenance therapy in patients with newly diagnosed multiple myeloma, This study was sponsored by Millennium Pharmaceuticals, a wholly owned subsidiary of Takeda Pharmaceutical Company.

Published
2019
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