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Brief Title: A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma
Official Title: Phase 2 Study of Linvoseltamab in Patients With Smoldering Multiple Myeloma at High Risk of Progression to Multiple Myeloma
Study ID: NCT05955508
Brief Summary: This study is researching an investigational drug called linvoseltamab ("study drug") in participants at high risk of developing multiple myeloma (MM), a group commonly labeled as high-risk smoldering multiple myeloma (HR-SMM). The aim of the study is to understand the safety and tolerability (how your body reacts to linvoseltamab) as well as the effectiveness (how well linvoseltamab eliminates plasma cells and prevents the development of MM) of the study drug. There are 2 parts to the study. * In Part 1, linvoseltamab will be given to a small number of participants to study the early side effects (safety) of the study drug and make sure the treatment is acceptable. * In Part 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat HR-SMM and prevent progression to MM. The study is looking at several other research questions, including: * How many participants treated with linvoseltamab (study drug) have improvement of their HR-SMM? * What side effects may happen from taking the study drug? * How much study drug is in your blood at different times? * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital Clinico Universitario Santiago de Compostela, Santiago de Compostela, A Coruna, Spain
Hospital Universitario Virgen de las Nieves, Granada, Andalusia, Spain
University Hospital of Cabuenes, Gijon, Asturias, Spain
Hospital Universitari Son Llatzer, Palma Mallorca, Baleares, Spain
Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain
Hospital Universitario Quiron Salud Madrid, Pozuelo de Alarcón, Madrid, Spain
Hospital Clinico Universitario Virgen De La Arrixaca, El Palmar, Murcia, Spain
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Clinica Universidad de Navarra - Madrid, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
University Hospital Doctor Peset, Valencia, , Spain
University Hospital La Fe, Valencia, , Spain
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR