Inicio
Proyectos y Estudios
Estudio de fase III, doble ciego y multicéntrico para evaluar la eficacia y la seguridad de CAEL-101 y el tratamiento para la discrasia de células plasmáticas frente a placebo y el tratamiento para la discrasia de células plasmáticas en pacientes con amiloidosis AL en estadio IIIa según la Clínica Mayo sin tratamiento previo para la discrasia de células plasmáticas.

Estudio de fase III, doble ciego y multicéntrico para evaluar la eficacia y la seguridad de CAEL-101 y el tratamiento para la discrasia de células plasmáticas frente a placebo y el tratamiento para la discrasia de células plasmáticas en pacientes con amiloidosis AL en estadio IIIa según la Clínica Mayo sin tratamiento previo para la discrasia de células plasmáticas.

Datos básicos

Código:: CAEL101-302
Protocolo:: CAEL101-302
EUDRACT:: 2020-000713-32
NCT:
Centro:: HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Dotación:
Año de incio:: 2022
Año de finalización:: 2024

ENSAYO CLÍNICO

Objetivos del proyecto

Objetivo Principal: Los objetivos principales son: • Determinar si CAEL-101 y el tratamiento para la discrasia de células plasmáticas mejora la supervivencia general en pacientes con amiloidosis AL en estadio IIIa según la Clínica Mayo que no han recibido tratamiento previo comparado con el tratamiento para la discrasia de células plasmáticas en monoterapia • Evaluar la seguridad y la tolerabilidad de CAEL-101 en combinación con el tratamiento para la discrasia de células plasmáticas Objetivos Secundarios: Los objetivos secundarios clave de este estudio son: • Evaluar la mejoría funcional, determinada por la distancia recorrida en la prueba de marcha de seis minutos (6MWT) • Evaluar la calidad de vida, determinada por la puntuación global del Cuestionario sobre miocardiopatías de Kansas City (KCCQ-OS) • Evaluar la calidad de vida, determinada por la puntuación del componente físico del cuestionario breve de 36 ítems, versión 2 (SF-36 v2 PCS) • Evaluar la mejoría cardíaca, determinada por el porcentaje de la deformación longitudinal global (DLG %)

Documentos

No hay documentos

Participantes

Javier De La Rubia Comos

Investigador Principal
Silvia García Palomares

Data Manager / Study Coordinator
Ana María Osa Sáez

Investigador Colaborador
José Luis Poveda Andrés

Investigador Colaborador
Rafael Andreu Lapiedra

Investigador Colaborador
Maria Perez Fernandez

Técnico Apoyo Investigación
Samuel Romero Domínguez

Investigador Colaborador
Isidro Jarque Ramos

Investigador Colaborador
Eva Dominguez Malfeito

Data Manager / Study Coordinator
Mario Arnao Herraiz

Investigador Colaborador
Elena Collado Ortega

Data Manager / Study Coordinator

Grupos

Hematología y Hemoterapia

Investigador Principal

Javier De La Rubia Comos
Grupo de Investigación Clínica y Traslacional en Cardiología

Investigador Principal

Esther Roselló Lletí
Farmacogenética

Investigador Principal

María José Herrero Cervera
Unidad de Descubrimiento de Fármacos (UDF)

Investigador Principal

Leonor Puchades Carrasco
Grupo de Investigación de Farmacia

Investigador Principal

Javier García Pellicer

Financiadores - Promotores

CAELUM BIOSCIENCES, INC.

Resultados del Ensayo Clínico

Publicaciones en Revistas 147

[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.

Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.12.007. 2025

[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.

Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.09.006. 2024

A glimpse into relapsed refractory multiple myeloma treatment in real-world practice in Spain: the GeminiS study.

Rios-Tamayo, Rafael; (...); Mateos, Maria Victoria

Article. 10.1080/16078454.2023.2178997. 2023

A multicentre ambispective observational study into the incidence and clinical management of aplastic anaemia in Spain (IMAS study)

Vallejo C; (...); Codesido ML

Article. 10.1007/s00277-023-05602-x. 2024

A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.

Zozaya, Neboa; (...); Verde, Luis

Article. 10.1017/S0266462322000459. 2022

A simple score to predict early severe infections in patients with newly diagnosed multiple myeloma

Encinas, Cristina; (...); Martinez-Lopez, Joaquin

Article. 10.1038/s41408-022-00652-2. 2022

Accuracy and prognostic impact of FDG PET/CT and biopsyin bone marrow assessment of follicular lymphomaat diagnosis: A Nation-Wide cohort study.

Rodenas-Quinonero, Isabel; (...); Ortuno, Francisco Jose

Article. 10.1002/cam4.5424. 2022

ADAMTS13 RECOVERY IN ACUTE THROMBOTIC THROMBOCYTOPENIC PURPURA AFTER CAPLACIZUMAB THERAPY. THE SPANISH REGISTRY.

Mingot-Castellano, Maria Eva; (...); Pascual Izquierdo, Cristina

Article. 10.1182/blood.2023022725. 2024

Alnuctamab (ALNUC; BMS-986349; CC-93269), a 2+1 B- Cell Maturation Antigen (BCMA) x CD3 T-Cell Engager (TCE), Administered Subcutaneously (SC) in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM): Updated Results from a Phase 1 First-in-Human Clinical Study

Bar, Noffar; (...); Costa, Luciano

Meeting Abstract. 10.1182/blood-2023-180013. 2023

Alnuctamab (ALNUC; BMS-986349; CC-93269), a B-Cell Maturation Antigen (BCMA) x CD3 T-Cell Engager (TCE), in Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM): Results from a Phase 1 First-in-Human Clinical Study

Wong, Sandy W.; (...); Costa, Luciano J.

Meeting Abstract. 10.1182/blood-2022-159009. 2022

Analysis of Peripheral Blood and Bone Marrow Residual Disease Dynamics during Intensive Treatment and Maintenance in Patients with Multiple Myeloma Included in the GEM12MENOS65 and GEM14MAIN Clinical Trials

Puig, Noemi; (...); Victoria Mateos, Maria

Meeting Abstract. 10.1182/blood-2023-184837. 2023

Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).

Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ

Letter. 10.1111/jdv.19432. 2023

Assessment of the potential value of plasma Torque Teno virus DNA load monitoring to predict cytomegalovirus DNAemia in patients with hematological malignancies treated with small molecule inhibitors: A proof-of-concept study.

de la Asunción CS; (...); Navarro D

Article. 10.1002/jmv.28933. 2023

Autologous stem cell transplantation as consolidation of first-line chemotherapy in patients with peripheral T-cell lymphoma: a multicenter GELTAMO/FIL study.

García-Sancho AM; (...); Caballero D

Article. 10.3324/haematol.2021.279426. 2022

Avatrombopag in immune thrombocytopenia: A real-world study of the Spanish ITP Group (GEPTI).

Pascual-Izquierdo C; (...); Mingot-Castellano ME

Article. 10.1002/ajh.27498. 2024

Belantamab Mafodotin in Combination with Vrd for the Treatment of Newly Diagnosed Transplant Eligible Multiple Myeloma Patients: Results from the Phase II, Open Label, Multicenter, GEM-BELA-Vrd Trial

Gonzalez-Calle, Veronica; (...); Mateos, Maria-Victoria

Meeting Abstract. 10.1182/blood-2022-162584. 2022

Belantamab Mafodotin in Combination with VRd for the Treatment of Newly Diagnosed Transplant Eligible Multiple Myeloma Patients: Results from the Phase II, Open Label, Multicenter, GEM-BELA-VRd Trial

Gonzalez-Calle, Veronica; (...); Mateos, Maria-Victoria

Meeting Abstract. https://doi.org/10.1182/blood-2022-162584. 2024

Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma Included in the Compassionate Use or the Expanded Access Program. Experience with a Spanish Cohort

De la Rubia, Javier; (...); Alegre, Adrian

Meeting Abstract. 10.1182/blood-2022-158538. 2022

Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma: Results of the Compassionate Use or the Expanded Access Program in Spain.

de la Rubia, Javier; (...); Alegre, Adrian

Article. 10.3390/cancers15112964. 2023

BUMEL vs MEL-200 prior autologous transplant for patients with newly diagnosed multiple myeloma previously treated with bortezomib, lenalidomide and dexamethasone: final results of a phase 3 trial

Lahuerta Palacios, Juan Jose; (...); Blade, Joan

Meeting Abstract. 2022

CA125: a new biomarker in patients with Fontan circulation (vol 76, pg 112, 2023)

Fuentes, Francisco Buendia; (...); Soriano, Joaquin Rueda

Correction. 10.1016/j.rec.2023.03.018. 2023

CA125: a new biomarker in patients with Fontan circulation.

Fuentes, Francisco Buendia; (...); Soriano, Joaquin Rueda

Article. 10.1016/j.rec.2022.05.029. 2022

Caplacizumab Frontline Added to Therapeutic Plasma Exchange and Immunosuppression Prevents Unfavorable Outcomes in Immune-Mediated TTP: An International Real-World Study of the TTP-IWG (The Capla 500 Project)

Coppo, Paul; (...); Scully, Marie

Meeting Abstract. 10.1182/blood-2023-179316. 2023

Caplacizumab Treatment in Elderly Patients with iTTP: Updated Experience from the Spanish TTP Registry

Gomez Segui, Ines; (...); De La Rubia, Javier

Meeting Abstract. 10.1182/blood-2023-180970. 2023

Circulating Tumor Cells for the Staging of Patients With Newly Diagnosed Transplant-Eligible Multiple Myeloma.

Garces, Juan-Jose; (...); Paiva, Bruno

Article. 10.1200/JCO.21.01365. 2022

Cis-Acting Splicing-Associated Variants Can Redefine the Molecular Signature of Genes Commonly Mutated in Acute Myeloid Leukemia

Morote-Faubel, Mireya; (...); Cervera, Jose

Meeting Abstract. 10.1182/blood-2023-177571. 2023

Clinical Characteristics, Treatment Approach and Long-Term Outcomes of 678 Patients with Symptomatic Waldenstrom's Macroglobulinemia: Comprehensive Insights from a Spanish Registry of IgM Gammapathies

Askari, Elham; (...); Garcia-Sanz, Ramon

Meeting Abstract. 10.1182/blood-2023-189581. 2023

Clinical Impact of Next Generation Flow in Bone Marrow Vs Qip-Mass Spectrometry in Peripheral Blood to Assess Minimal Residual Disease in Newly Diagnosed Multiple Myeloma Patients Receiving Maintenance As Part of the GEM2014MAIN Trial

Puig, Noemi; (...); Mateos, Maria-Victoria

Meeting Abstract. 10.1182/blood-2022-165441. 2022

CMV REACTIVATIONS IN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT FROM HLA-MATCHED AND HAPLOIDENTICAL DONORS WITH POST-TRANSPLANT CYCLOPHOSPHAMIDE.

Chorão P; (...); Sanz J

Article. 10.1016/j.jtct.2024.01.082. 2024

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano JB; (...); Soto-Ortega I

Article. 10.1016/j.farma.2023.01.003. 2023

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada

Article. 10.1016/j.farma.2023.04.002. 2023

COST-EFFECTIVENESS ANALYSIS OF DIFELIKEFALIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE ASSOCIATED-PRURITUS IN SPAIN

Sanchez-Alvarez, Emilio E.; (...); Hernaez Colque, M.

Meeting Abstract. 2024

Curative Strategy (GEM-CESAR) for High-Risk Smoldering Myeloma (SMM): Post-Hoc Analysis of Sustained Undetectable Measurable Residual Disease (MRD)

Mateos, Maria-Victoria; (...); Paiva, Bruno

Meeting Abstract. 10.1182/blood-2022-159606. 2022

Curative Strategy for High-Risk Smoldering Myeloma: Carfilzomib, Lenalidomide, and Dexamethasone (KRd) Followed by Transplant, KRd Consolidation, and Rd Maintenance.

Mateos, Maria-Victoria; (...); San-Miguel, Jesus F

Article. 10.1200/JCO.23.02771. 2024

Cybersecurity, a priority for pharmacy services in the age of artificial intelligence.

Hernández Marín CM, Monte-Boquet E, Poveda Andrés JL

Editorial Material. 10.1016/j.farma.2024.08.001. 2024

Cytogenetic Assessment and Risk Stratification in Myelofibrosis with Optical Genome Mapping.

Diaz-Gonzalez, Alvaro; (...); Such, Esperanza

Article. 10.3390/cancers15113039. 2023

Cytokine response as a biomarker for early diagnosis and outcome prediction of stem cell transplant recipients and acute leukemia patients with invasive aspergillosis.

Puerta-Alcalde, Pedro; (...); Garcia-Vidal, Carolina

Article. 10.1093/mmy/myac038. 2022

Chronic liver disease-associated severe thrombocytopenia in Spain: Results from a retrospective study using machine learning and natural language processing.

Calleja-Panero, Jose Luis; (...); Gonzalez Calvo, Jose

Article. 10.1016/j.gastrohep.2023.05.010. 2023

Daratumumab, carfilzomib, and dexamethasone in relapsed or refractory myeloma: final analysis of PLEIADES and EQUULEUS.

Moreau, Philippe; (...); Goldschmidt, Hartmut

Letter. 10.1038/s41408-023-00805-x. 2023

Definition and Clinical Significance of the Monoclonal Gammopathy of Undetermined Significance-Like Phenotype in Patients With Monoclonal Gammopathies.

Burgos, Leire; (...); Paiva, Bruno

Article. 10.1200/JCO.22.01916. 2023

Depth of Response of Isatuximab (Isa) plus Carfilzomib (K) and Dexamethasone (d) in Relapsed Multiple Myeloma: IKEMA Updated Analysis

Joseph, Mikhael; (...); Meletios, A. Dimopoulos

Article. 2022

Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.

Abad, Maria Reyes; (...); Gil, Alicia

Article. 10.33393/grhta.2024.3041. 2024

Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis

Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther

Article. 10.1002/jvc2.275. 2024

Editorial: Infectious diseases and hematology: diagnosis and management

Gonzalez-Lopez, Tomas Jose; (...); Di Micco, Pierpaolo

Editorial Material. 10.3389/fmed.2024.1385874. 2024

Effect of Caplacizumab in the Recovery of ADAMTS13 Level in Patients with Autoimmune Thrombotic Thrombocytopenic Purpura. Analysis from the Spanish Registry (REPTT)

Eva Mingot, Maria; (...); Del Rio Garma, Julio

Meeting Abstract. 10.1182/blood-2023-182876. 2023

Efficacy and Safety of Treatment Venetoclax Monotherapy or Combined with Rituximab in Patients with Relapsed/ Refractory Chronic Lymphocytic Leukemia (CLL) in the Real-World Setting in Spain: An Update of the Venares Study

Ferra, Christelle; (...); Baltasar, Patricia

Meeting Abstract. 10.1182/blood-2022-162186. 2022

ELTROMBOPAG ADDED TO STANDARD IST IS SUPERIOR TO IST ALONE AS FRONT-LINE TREATMENT FOR SEVERE APLASTIC ANEMIA: FINAL 2-YEAR ANALYSIS OF EBMT-SAAWP RACE STUDY

Risitano, Antonio Maria; (...); de Latour, Regis Peffault

Meeting Abstract. 2024

Enhancing Cytogenetic Diagnostics: Incorporating Optical Genome Mapping in the Laboratory Routine

Diaz-Gonzalez, Alvaro; (...); Such, Esperanza

Meeting Abstract. 10.1182/blood-2023-180691. 2023

Epidemiology of Hereditary Thrombotic Thrombocytopenic Purpura (TTP) in Spain: Preliminary Results of a Study of the Spanish TTP Registry (REPTT)

Segui, Ines Gomez; (...); Garma, Julio Del Rio

Meeting Abstract. 2024

Final Analysis of the Phase 2 ELM-2 Study: Odronextamab in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)

Ayyappan, Sabarish; (...); Prince, H. Miles

Meeting Abstract. 10.1182/blood-2023-179818. 2023

Fostamatinib effectiveness and safety for immune thrombocytopenia in clinical practice.

Gonzalez-Lopez, Tomas Jose; (...); Garcia-Donas Gabaldon, Gloria

Article. 10.1182/blood.2024024250. 2024

Gastric Bleeding in Stem Cell Transplantation: A Focus on Gastric Vascular Ectasia Under Post-Transplant Cyclophosphamide, Sirolimus, and Mycophenolate Mofetil Prophylaxis.

Eirís J; (...); Sanz J

Article. 10.1016/j.jtct.2024.10.009. 2024

Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.

Plaza J; (...); Moret-Tatay I

Article. 10.3390/ijms25073717. 2024

Genomic profiling of high-risk smoldering myeloma patients treated with a curative strategy: a biological study of the phase II GEM CESAR clinical trial

Medina, Alejandro; (...); Garcia-Sanz, Ramon

Meeting Abstract. 2023

Geriatric assessment in hematology scale predicts treatment tolerability in older patients diagnosed with hematological malignancies: The RETROGAH study.

de la Rubia J; (...); Bonanad, Santiago

Article. 10.1016/j.jgo.2022.10.016. 2022

GERMLINE PREDISPOSITION TO MYELOID MALIGNANCIES IN A CONSECUTIVE COHORT OF 183 PATIENTS

Santiago, M.; (...); Cervera-Zamora, J.

Meeting Abstract. 10.1016/j.leukres.2023.107247. 2023

Healthcare Resource Utilization among Patients between 60-75 Years with Secondary Acute Myeloid Leukemia Receiving Intensive Chemotherapy Induction: A Spanish Retrospective Observational Study

Solana-Altabella, Antonio; (...); Martinez-Cuadron, David

Article. 10.3390/cancers14081921. 2022

Health-Related Quality of Life and Symptoms in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma Treated with Odronextamab Monotherapy in the Phase 2 ELM-2 Study

Iskierka-Jazdzewska, Elzbieta; (...); Ivanescu, Cristina

Meeting Abstract. 10.1182/blood-2023-180743. 2023

Ibrutinib followed by ofatumumab consolidation in previously untreated patients with chronic lymphocytic leukemia (CLL): GELLC-7 trial from the Spanish group of CLL (GELLC).

Abrisqueta, Pau; (...); Bosch, Francesc

Article. 10.1016/j.eclinm.2024.102642. 2024

IDIOPATHIC UPPER GASTROINTESTINAL BLEEDING AFTER ALLOGENEIC STEM CELL TRANSPLANTATION: AN UNPRECEDENTED COMPLICATION

Eiris, Juan; (...); Balaguer-Rosello, Aitana

Meeting Abstract. 2024

IFISTRATEGY: Spanish National Survey of Invasive Fungal Infection in Hemato-Oncologic Patients.

Vallejo, Carlos; (...); Peman, Javier

Article. 10.3390/jof9060628. 2023

Immune biomarkers of survival and infection-related mortality in multiple myeloma (MM) patients treated with lenalidomide and dexamethasone (Rd)

Maia, Catarina; (...); Paiva, Bruno

Meeting Abstract. 2022

Immune Biomarkers of Survival and Severe Infection in Newly Diagnosed Multiple Myeloma (NDMM) Patients (pts) Treated with the Backbone Regimen Lenalidomide and Dexamethasone (Rd)

Maia, Catarina; (...); Paiva, Bruno

Meeting Abstract. 10.1182/blood-2022-163058. 2022

Immune thrombotic thrombocytopenic purpura in older patients: Results from the Spanish TTP Registry (REPTT).

Gomez-Segui, I; (...); de la Rubia Comos, J

Article. 10.1111/bjh.19109. 2023

Immunobiology of cytomegalovirus infection in patients with haematological malignancies undergoing treatment with small molecule inhibitors.

de la Asuncion Carlos, Solano; (...); Navarro, David

Letter. 10.1111/bjh.18655. 2023

Immunoparesis recovery in newly diagnosed transplant ineligible multiple myeloma patients, an independent prognostic factor that complements minimal residual disease.

Lakhwani S; (...); Hernández MT

Article. 10.1007/s00277-024-06031-0. 2024

Immunoparesis Recovery in Transplant-Ineligible Newly Diagnosis Multiple Myeloma Patients: An Independent Prognosis Factor That Could Complement Prognostic Value of Minimal Residual Disease

Lakhwani, Sunil; (...); Hernandez, Miguel-Teodoro

Meeting Abstract. 10.1182/blood-2022-166826. 2022

Immunotherapy in multiple myeloma.

Asensi Cantó P, Arnao Herraiz M, de la Rubia Comos J

Article. 10.1016/j.medcli.2023.11.019. 2024

Immunotherapy May be Preferable to Chemotherapy As Second-Line Treatment for POD24 Follicular Lymphoma (FL) Patients

Serna, Angel; (...); Abrisqueta, Pau

Meeting Abstract. 10.1182/blood-2024-207871. 2024

IMPACT OF POSTTRANSPLANT CYCLOPHOSPHAMIDE ON TRANSFUSION REQUIREMENTS IN HLA MATCHED SIBLING PERIPHERAL BLOOD STEM CELL TRANSPLANTATION.

Marco-Ayala, Javier; (...); Solves, Pilar

Article. 10.1016/j.jtct.2023.01.009. 2023

Impact of pre- and/or post-autologous stem cell transplantation exposure to brentuximab vedotin on survival outcomes in patients with high-risk Hodgkin lymphoma.

Martinez, Carmen; (...); Garcia-Sanz, Ramon

Article. 10.1007/s00277-022-05011-6. 2022

Improved outcomes in allo-HCT for multiple myeloma patients with thiotepa-busulfan-fludarabine conditioning regimen and post-transplant cyclophosphamide, sirolimus and mycophenolate mofetil

de la Rubia, Javier; (...); Sanz, Miguel

Meeting Abstract. 2023

Incidence and Risk Factors for Development of Cardiac Toxicity in Adult Patients with Newly Diagnosed Acute Myeloid Leukemia

Boluda, Blanca; (...); Montesinos, Pau

Article. 10.3390/cancers15082267. 2023

Incidence, risk factors and therapy response of acute graft-versus-host disease after myeloablative hematopoietic stem cell transplantation with posttransplant cyclophosphamide.

Asensi Cantó P; (...); Sanz J

Article. 10.1038/s41409-024-02391-3. 2024

Incidence, risk factors, and outcomes of BK hemorrhagic cystitis in hematopoietic stem cell transplantation from HLA-matched and haploidentical donors with post-transplant cyclophosphamide.

Chorao, Pedro; (...); Sanz, Jaime

Article. 10.1016/j.jtct.2024.12.006. 2024

Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.

Pozo-Rosich P; (...); Irimia P

Article. 10.1186/s10194-024-01747-w. 2024

Isatuximab plus carfilzomib and dexamethasone in patients with relapsed multiple myeloma based on prior lines of treatment and refractory status: IKEMA subgroup analysis.

Dimopoulos, Meletios A.; (...); Hajek, Roman

Article. 10.1002/ajh.26602. 2022

Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.

Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula

Article. 10.3390/antibiotics13080706. 2024

Isolated and Dynamic Peripheral Blood Residual Disease Status Characterized By Mass Spectrometry Predicts Outcome in Patients with High Risk Smoldering Multiple Myeloma Treated in the GEM-CESAR Trial

Puig, Noemi; (...); Victoria Mateos, Maria

Meeting Abstract. 10.1182/blood-2023-182964. 2023

Lenalidomide and dexamethasone maintenance with or without ixazomib, tailored by residual disease status in myeloma.

Rosinol, Laura; (...); Blade, Joan

Article. 10.1182/blood.2022019531. 2023

Lenalidomide in combination with R-ESHAP in patients with relapsed or refractory diffuse large B-cell lymphoma: A phase 2 study from GELTAMO.

Martin Garcia-Sancho, A.; (...); Caballero, D.

Article. 10.1111/bjh.18989. 2023

Longitudinal outcome over four decades of allogeneic stem cell transplantation: a single center experience.

Sanz, Miguel Angel; (...); Sanz, Jaime

Article. 10.1038/s41409-024-02319-x. 2024

Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.

Vázquez Polo A; (...); Vázquez Costa JF

Article. 10.20960/nh.03946. 2022

Mezigdomide plus Dexamethasone in Relapsed and Refractory Multiple Myeloma.

Richardson PG; (...); Bahlis NJ

Article. 10.1056/NEJMoa2303194. 2023

Multi- Omics Exploration of Adaptive Mechanism to BTK Inhibition By Ibrutinib in CLL Identified TMBIM6/BI-1 As a Poor Prognosis Variable and Potential Therapeutic Target

Medina, Daniel; (...); Crespo, Marta

Meeting Abstract. 10.1182/blood-2023-185683. 2023

National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies

Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis

Meeting Abstract. 10.1182/blood-2022-169938. 2022

NEUROLOGIC COMPLICATIONS AFTER ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION WITH CALCINEURIN-FREE GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS

Balaguer Rosello, Aitana; (...); Sanz, Jaime

Meeting Abstract. 2023

New challenges of advanced therapies.

Megías-Vericat JE; (...); Poveda Andrés JL

Article. 10.1016/j.farma.2023.11.008. 2024

NGS-Based Molecular Karyotyping of Multiple Myeloma: Results from the GEM12 Clinical Trial.

Rosa-Rosa, Juan Manuel; (...); Martinez-Lopez, Joaquin

Article. 10.3390/cancers14205169. 2022

Novel Agents May be Preferable to Standard Chemotherapy in Second-Line for Early Relapsing Follicular Lymphoma (FL) Patients

Serna, Angel; (...); Abrisqueta Costa, Pau

Meeting Abstract. 10.1182/blood-2023-186019. 2023

Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus

Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis

Article. 10.1097/MD.0000000000032208. 2022

Odronextamab in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL): Results from a Prespecified Analysis of the Pivotal Phase II Study ELM-2

Kim, Won-Seog; (...); Walewski, Jan

Meeting Abstract. 10.1182/blood-2022-158406. 2022

ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.

Poveda JL; (...); Badia X

Article. 10.1186/s13023-022-02610-4. 2023

Ofatumumab as part of reduced intensity conditioning in high risk B-cell lymphoma patients: final long-term analysis from a prospective multicenter Phase-II Trial

Cabrero M; (...); Caballero D

Article. 10.1038/s41409-023-02171-5. 2024

Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes

Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor

Review. 10.3390/biology12091159. 2023

OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT

Flores-Moreno, S.; (...); Gil, A.

Meeting Abstract. 2024

Outcomes of Patients with Hodgkin Lymphoma Receiving Brentuximab Vedotin (BV) As Maintenance Therapy after ASCT According to Previous Exposure to BV. a Retrospective Analysis of the EBMT Lymphoma Working Party in Collaboration with Geltamo, FIL, Lysarc, and Turkish Lymphoma Group

Munoz, Maria Carmen Martinez; (...); Balari, Anna Sureda

Meeting Abstract. 10.1182/blood-2024-205007. 2024

P-137: ITHACA, a randomized multicenter phase 3 study of Isatuximab in combination with Lenalidomide and Dexamethasone in high-risk smoldering Multiple Myeloma: safety run-in preliminary results (vol 21, pg S109, 2021)

Ghobrial, Irene M.; (...); Mateos, Maria-Victoria

Correction. 10.1016/j.clml.2022.03.011. 2022

Panel Sequencing for Clinically Oriented Variant Screening and Copy Number Detection in Chronic Lymphocytic Leukemia Patients

Ibanez, Mariam; (...); Luna I

Article. 10.3390/diagnostics12040953. 2022

Paradoxical Findings in Patients with Paroxysmal Nocturnal Hemoglobinuria Treated with C5 Inhibitors: Suboptimal Disease Control Perceived As Satisfactory

Gaya, Anna; (...); Vallejo, Carlos

Meeting Abstract. 10.1182/blood-2023-185939. 2023

Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.

Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis

Article. 10.3390/ijms26041760. 2025

Post-transplant cyclophosphamide and sirolimus based graft-versus-host disease prophylaxis after allogeneic stem cell transplantation for acute myeloid leukemia.

Lazzari, Lorenzo; (...); Sanz, Jaime

Article. 10.1038/s41409-022-01725-3. 2022

Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services

Company Albir MJ, Poveda Andrés JL, Edo Solsona MD

Article. 10.1016/j.farma.2023.06.0131130. 2024

Primary and secondary immune thrombocytopenia (ITP): Time for a rethink.

Gonzalez-Lopez, Tomas Jose; (...); Fernandez-Fuertes, Fernando

Article. 10.1016/j.blre.2023.101112. 2023

Prognostic Factors and Treatment Strategy in Patients with Hodgkin Lymphoma and HIV Infection Treated with ABVD and CART: A Retrospective Study from Spanish Group Geltamo

Huguet, Maria; (...); Navarro, Jose-Tomas

Meeting Abstract. 10.1182/blood-2023-189756. 2023

Prognostic Value of Serum Paraprotein Response Kinetics in Patients With Newly Diagnosed Multiple Myeloma.

Tamariz-Amador, Luis-Esteban; (...); Troconiz, Inaki F.

Article. 10.1016/j.clml.2022.04.024. 2022

Púrpura trombocitopénica trombótica inmune: sospecha y manejo básico en los servicios de urgencias. Revisión y consenso de un grupo de expertos de las sociedades científicas SEHH y SEMES.

Pascual-Izquierdo, Cristina; (...); de la Rubia Comos, Javier

Article. 10.55633/s3me/E099.2023. 2023

Real world evaluation of teclistamab in patients with RRMM: results from the IMF immunotherapy database project

Costa, Luciano; (...); Wong, Sandy

Meeting Abstract. 2023

Real-life clinical practice in Spain in the setting of new drug availability for ITP treatment. A Delphi-based Spanish expert panel consensus.

Gonzalez-Lopez, Tomas Jose; (...); Jarque, Isidro

Article. 10.1080/09537104.2024.2336104. 2024

Recommendations for the study of monoclonal gammopathies in the clinical laboratory. A consensus of the Spanish Society of Laboratory Medicine and the Spanish Society of Hematology and Hemotherapy. Part I: update on laboratory tests for the study of monoclonal gammopathies.

Cardenas, Maria C.; (...); Cruz-Iglesias, Elena

Article. 10.1515/cclm-2023-0326. 2023

Recommendations for the study of monoclonal gammopathies in the clinical laboratory. A consensus of the Spanish Society of Laboratory Medicine and the Spanish Society of Hematology and Hemotherapy. Part II: methodological and clinical recommendations for the diagnosis and follow-up of monoclonal gammopathies

Cardenas, Maria C.; (...); Cruz-Iglesias, Elena

Article. 10.1515/cclm-2023-0325. 2023

Recovery of Uninvolved Heavy/Light Chain Pair Immunoparesis during Maintenance Is an Independent Prognostic Factor for Multiple Myeloma and Could Complement Prognosis Value of Minimal Residual Disease

Lakhwani, Sunil; (...); Hernandez, Miguel-Teodoro

Meeting Abstract. 10.1182/blood-2022-167247. 2022

Recovery of uninvolved heavy/light chain pair immunoparesis in newly diagnosed transplant-eligible myeloma patients complements the prognostic value of minimal residual disease detection.

Lakhwani S; (...); Hernández MT

Article. 10.3324/haematol.2023.284154. 2024

Reduced incidence of neurologic complications after allogeneic hematopoietic stem cell transplantation with calcineurin-free graft-versus-host disease prophylaxis.

Balaguer-Rosello, Aitana; (...); Sanz, Jaime

Article. 10.1016/j.jtct.2023.07.008. 2023

Selective IgA Deficiency and Blood Component Transfusion: In Search of the Lost Evidence

Solves, Pilar; (...); de la Rubia, Javier

Article. 10.3390/hemato5020009. 2024

Should we consider caplacizumab as routine treatment for acute thrombotic thrombocytopenic purpura? An expert perspective on the pros and cons.

Seguí IG; (...); de la Rubia J

Article. 10.1080/17474086.2024.2318347. 2024

Single versus tandem autologous stem-cell transplantation in patients with newly diagnosed multiple myeloma and high-risk cytogenetics: a retrospective study of the PETHEMA/Spanish Myeloma Group (GEM)

Villalba, Ana; (...); De la Rubia, Javier

Meeting Abstract. 2022

Single-point and kinetics of peripheral residual disease by mass spectrometry to predict outcome in patients with high risk smoldering multiple myeloma included in the GEM-CESAR trial.

Puig N; (...); Mateos MV

Article. 10.3324/haematol.2024.285742. 2024

SMPTall man lettering application in medication information systems as a quality and safety strategy in hospital organization

Iglesias Gomez, Ruben; (...); Poveda Andres, Jose Luis

Article. 10.1111/jcpt.13703. 2022

Sustained Recovery of Uninvolved Heavy/Light Chain Pair Immunoparesis during Maintenance Discriminates Patients with Sustained Negative Minimal Residual Disease

Lakhwani, Sunil; (...); Teodoro Hernandez Garcia, Miguel

Meeting Abstract. 10.1182/blood-2023-179452. 2023

Systematic Review of Pharmacogenetics of ABC and SLC Transporter Genes in Acute Myeloid Leukemia

Megías-Vericat JE; (...); Montesinos P

Review. 10.3390/pharmaceutics14040878. 2022

T-cell Depleted Peripheral Blood versus Unmanipulated Bone Marrow in Matched Sibling Transplantation for Aplastic Anemia.

Chorao, Pedro; (...); Sanz, Jaime

Article. 10.1016/j.jtct.2023.01.016. 2023

The association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity

Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar

Article. 10.1007/s00431-022-04628-z. 2022

The contribution of fenfluramine to the treatment of Dravet syndrome in Spain through Multi-Criteria Decision Analysis.

Gil-Nagel A; (...); Gil A

Article. 10.1016/j.yebeh.2022.108711. 2022

The genomic profiling of high-risk smoldering myeloma patients treated with an intensive strategy unveils potential markers of resistance and progression.

Medina-Herrera A; (...); Garcia-Sanz R

Article. 10.1038/s41408-024-01053-3. 2024

The Role of ADAMTS13 Activity Levels on Disease Exacerbation or Relapse in Patients with Immune-Mediated Thrombotic Thrombocytopenic Purpura: Post Hoc Analysis of the Phase 3 HERCULES and Post-HERCULES Studies

Strebel, Johanna A. Kremer Hovinga; (...); Scully, Marie

Meeting Abstract. 10.1182/blood-2022-156306. 2022

The Value of Bone Marrow Assessment by FDG PET/CT, Biopsy and Aspirate in the Upfront Evaluation of Mantle Cell Lymphoma: A Nationwide Cohort Study

Quinonero, Isabel Rodenas; (...); Ortuno, Francisco Jose

Article. 10.3390/cancers16244189. 2024

The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).

Badia, Xavier; (...); Valles, Joan-Antoni

Article. 10.1186/s13023-024-03324-5. 2024

Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.

Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis

Article. 10.1136/ejhpharm-2024-004184. 2024

Transfusion Burden in Allogeneic Hematopoietic Stem Cell Transplantation over Time: Experience from a Single Institution.

Solves, Pilar; (...); Sanz, Jaime

Article. 10.3390/jcm12103467. 2023

Use of optical genome mapping in the cytogenetic diagnosis of multiple myeloma

de la Rubia, Javier; (...); Such, Esperanza

Meeting Abstract. 2023

VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA

Poveda, J. L.; (...); Lizan, L.

Meeting Abstract. 2023