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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Interventions

Linvoseltamab

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Trial Management

Affiliation: Regeneron Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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