Portal de recerca
Estudio en fase Ib abierto para evaluar la seguridad y la tolerabilidad de modakafusp alfa intravenoso como parte de un tratamiento combinado en pacientes adultos con mieloma múltiple.
Dades bàsiques
- Protocol:
- TAK-573-1502
- EURDRACT:
- 2022-001418-20
- NCT:
- Centre:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Any inici:
- 2023
- Any de finalització:
- 2024
Objectius del projecte
Objetivo Principal: Grupo 1: mieloma múltiple de nuevo diagnóstico (MMND), mantenimiento - Determinar la seguridad y la tolerabilidad de modakafusp alfa en biterapia con lenalidomida como mantenimiento para pacientes adultos con MMND después de un autotransplante de progenitores hematopoyéticos (ATPH). - Determinar la DRF2 de la biterapia con modakafusp alfa. Grupo 2: mieloma múltiple recidivante o resistente al tratamiento (MMRR), combinaciones dobles (biterapias) - Determinar la seguridad y la tolerabilidad modakafusp alfa como parte de una biterapia para pacientes adultos con MMRR. - Determinar la DRF2 de la biterapia con modakafusp alfa (dosis recomendadas de las combinaciones dobles). Grupo 3: Combinaciones triples para MMRR (triterapias) - Determinar la seguridad y la tolerabilidad modakafusp alfa como parte de una triterapia para pacientes adultos con MMRR. - Determinar la DRF2 de la triterapia con modakafusp alfa (dosis recomendadas de las combinaciones triples). Objetivos Secundarios: Grupo 1: Mantenimiento para MMND - Evaluar la eficacia preliminar de modakafusp alfa en biterapia con lenalidomida como mantenimiento para pacientes adultos con MMND después de un ATPH. - Evaluar la tasa y la duración de la negatividad de la enfermedad residual mínima o cuantificable (ERM). - Recoger datos de FC como apoyo a la FC de la población y los análisis de respuesta a la exposición a modakafusp. alfa cuando se administra como politerapia. - Caracterizar el perfil de inmunogenia de modakafusp alfa cuando se administra como politerapia. Grupo 2: Biterapias para el MMRR - Evaluar la eficacia preliminar de modakafusp alfa como parte de una biterapia para pacientes adultos con MMRR. - Recoger datos de FC de modakafusp alfa como apoyo a la FC de la población y los análisis de respuesta a la exposición a modakafusp alfa cuando se administra como politerapia. Consulte el apartado 5.1.2 para obtener una lista completa de los objetivos secundarios.
Documents
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Participants
Grups d'Investigació
Finançadors - Promotors
Resultats de l'Assaig Clínic
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ADAMTS13 RECOVERY IN ACUTE THROMBOTIC THROMBOCYTOPENIC PURPURA AFTER CAPLACIZUMAB THERAPY. THE SPANISH REGISTRY.
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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
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Meeting Abstract. 10.1182/blood-2023-184837. 2023
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Caplacizumab Treatment in Elderly Patients with iTTP: Updated Experience from the Spanish TTP Registry
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Cis-Acting Splicing-Associated Variants Can Redefine the Molecular Signature of Genes Commonly Mutated in Acute Myeloid Leukemia
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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
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Cytogenetic Assessment and Risk Stratification in Myelofibrosis with Optical Genome Mapping.
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Design and Validation of a Custom Next-Generation Sequencing Panel in Pediatric Acute Lymphoblastic Leukemia.
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Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.
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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
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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
Final Analysis of the Phase 2 ELM-2 Study: Odronextamab in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
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Meeting Abstract. 10.1182/blood-2023-179818. 2023
Genomic profiling of high-risk smoldering myeloma patients treated with a curative strategy: a biological study of the phase II GEM CESAR clinical trial
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Meeting Abstract. 2023
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GERMLINE PREDISPOSITION TO MYELOID MALIGNANCIES IN A CONSECUTIVE COHORT OF 183 PATIENTS
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Meeting Abstract. 10.1016/j.leukres.2023.107247. 2023
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Meeting Abstract. 10.1182/blood-2023-180743. 2023
High-risk cytogenetic abnormalities in multiple myeloma: PETHEMA-GEM experience
Rodriguez-Otero, Paula; (...); Gutierrez, Norma
Meeting Abstract. 2023
IFISTRATEGY: Spanish National Survey of Invasive Fungal Infection in Hemato-Oncologic Patients.
Vallejo, Carlos; (...); Peman, Javier
Article. 10.3390/jof9060628. 2023
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.
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Letter. 10.1111/bjh.18655. 2023
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Article. 10.1016/j.medcli.2023.11.019. 2024
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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
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
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Rosinol, Laura; (...); Blade, Joan
Article. 10.1182/blood.2022019531. 2023
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Mezigdomide plus Dexamethasone in Relapsed and Refractory Multiple Myeloma.
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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
NEUROLOGIC COMPLICATIONS AFTER ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION WITH CALCINEURIN-FREE GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS
Balaguer Rosello, Aitana; (...); Sanz, Jaime
Meeting Abstract. 2023
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
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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
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Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
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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
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.
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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
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Meeting Abstract. 2023
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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.
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Meeting Abstract. 10.1182/blood-2023-179452. 2023
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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