Portal de investigación
- Inicio
- Proyectos y Estudios
- ESTUDIO EN FASE III, ABIERTO, DE 2 GRUPOS, MULTICÉNTRICO Y ALEATORIZADO PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDA EN COMPARACIÓN CON DARATUMUMAB + LENALIDOMIDA + DEXAMETASONA EN PARTICIPANTES CON MIELOMA MÚLTIPLE DE DIAGNÓSTICO RECIENTE NO APTOS PARA TRASPLANTE
ESTUDIO EN FASE III, ABIERTO, DE 2 GRUPOS, MULTICÉNTRICO Y ALEATORIZADO PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDA EN COMPARACIÓN CON DARATUMUMAB + LENALIDOMIDA + DEXAMETASONA EN PARTICIPANTES CON MIELOMA MÚLTIPLE DE DIAGNÓSTICO RECIENTE NO APTOS PARA TRASPLANTE
Datos básicos
- Protocolo:
- C1071006
- EUDRACT:
- 2021-000803-20
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Año de incio:
- 2023
- Año de finalización:
Objetivos del proyecto
Objetivo Principal: Parte 1 Evaluar las TLD de EDR para seleccionar una DRF3 para la combinación que se utilizará en la parte 2 de este estudio Parte 2 Comparar la eficacia de EDR (grupo A) frente a DRd (grupo B) medida por el estado de EMR y la SSP Objetivos Secundarios: Parte 1 • Evaluar perfil de seguridad global de EDR para seleccionar una DRF3 de la combinación para usarla en la parte 2 de este estudio. • Evaluar eficacia de EDR para seleccionar una DRF3 de la combinación para usarla en la parte 2 de este estudio. • Evaluar FC de elranatamab cuando se utiliza en combinación con daratumumab y lenalidomida • Evaluar inmunogenicidad de elranatamab cuando se utiliza en combinación con daratumumab y lenalidomida • Evaluar FC de daratumumab y lenalidomida cuando se utiliza en combinación con elranatamab Parte 2 • Evaluar eficacia del grupo A y el grupo B • Determinar seguridad y tolerabilidad de elranatamab cuando se utiliza en monoterapia y en combinación con daratumumab + lenalidomida • Evaluar FC de elranatamab en combinación con daratumumab + lenalidomida • Evaluar inmunogenicidad de elranatamab cuando se utiliza en combinación con daratumumab y lenalidomida • Evaluar impacto del tratamiento en la CdVRS de los participantes
Documentos
- No hay documentos
Participantes
Grupos
Financiadores - Promotores
Resultados del Ensayo Clínico
[Translated article] New challenges in advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2024.05.001. 2024
[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
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
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
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
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: Results of the Compassionate Use or the Expanded Access Program in Spain.
de la Rubia, Javier; (...); Alegre, Adrian
Article. 10.3390/cancers15112964. 2023
Benefits of physical activity self-monitoring in patients with haemophilia: a prospective study with one-year follow-up.
Pérez-Alenda S; (...); Núñez-Cortés R
Article. 10.1111/hae.14988. 2024
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
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
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
CMV REACTIVATIONS IN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT FROM HLA-MATCHED AND HAPLOIDENTICAL DONORS WITH POST-TRANSPLANT CYCLOPHOSPHAMIDE.
Article. 10.1016/j.jtct.2024.01.082. 2024
Cost-effectiveness and cost-utility analysis of haemate-P versus other von willebrand disease treatments in Spain.
Megias-Vericat, Juan E; (...); Yan, Songkai
Article. 10.1080/13696998.2025.2474886. 2025
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
Cytogenetic Assessment and Risk Stratification in Myelofibrosis with Optical Genome Mapping.
Diaz-Gonzalez, Alvaro; (...); Such, Esperanza
Article. 10.3390/cancers15113039. 2023
Dermatological toxicities of talquetamab, a new bispecific antibody: case series and literature review.
Mansilla-Polo M; (...); Botella-Estrada R
Letter. 10.1111/ddg.15502. 2024
Design and Validation of a Custom Next-Generation Sequencing Panel in Pediatric Acute Lymphoblastic Leukemia.
Gil, Jose Vicente; (...); Barragan, Eva
Article. 10.3390/ijms24054440. 2023
Development and testing of a mobile app for systematic collection of patient-reported outcomes (PROs) in patients with hemophilia.
Megias-Vericat, J E; (...); Poveda Andres, J L
Letter. 10.1016/j.thromres.2024.109122. 2024
Drug-drug interactions associated with FLT3 inhibitors for acute myeloblastic leukemia: current landscape.
Solana-Altabella, Antonio; (...); Montesinos, Pau
Article. 10.1080/17512433.2023.2174523. 2023
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
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
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
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
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
High-risk cytogenetic abnormalities in multiple myeloma: PETHEMA-GEM experience
Rodriguez-Otero, Paula; (...); Gutierrez, Norma
Meeting Abstract. 2023
High-risk cytogenetic abnormalities in multiple myeloma: PETHEMA-GEM experience
Gonzalez-Calle, Veronica; (...); Gutierrez, Norma C.
Article. 10.1002/hem3.70031. 2024
IDIOPATHIC UPPER GASTROINTESTINAL BLEEDING AFTER ALLOGENEIC STEM CELL TRANSPLANTATION: AN UNPRECEDENTED COMPLICATION
Eiris, Juan; (...); Balaguer-Rosello, Aitana
Meeting Abstract. 2024
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
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
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
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
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
Mental, emotional and social dimensions of quality of life and their relationship with physical and functional status in adults with haemophilia.
Rodríguez MA; (...); Chimeno-Hernández A
Article. 10.1016/j.thromres.2024.109181. 2024
Mezigdomide plus Dexamethasone in Relapsed and Refractory Multiple Myeloma.
Richardson PG; (...); Bahlis NJ
Article. 10.1056/NEJMoa2303194. 2023
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
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
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
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
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
Real world evaluation of teclistamab in patients with RRMM: results from the IMF immunotherapy database project
Costa, Luciano; (...); Wong, Sandy
Meeting Abstract. 2023
Real-World Experience in Extracorporeal photopheresisfor adults with graft-versus-host disease.
Asensi Cantó P; (...); Gómez-Seguí I
Article. 10.1016/j.jtct.2023.09.001. 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 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
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-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
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
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