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Brief Title: A Study of ANV419 Alone or in Combination With Approved Treatments in Patients With Multiple Myeloma (OMNIA-2)
Official Title: A Phase 1 Study of ANV419 as Monotherapy, and ANV419 in Combination With Daratumumab or With Lenalidomide Plus Low-Dose Dexamethasone, in Patients With Relapsed or Refractory Multiple Myeloma (OMNIA-2)
Study ID: NCT05641324
Brief Summary: The purpose of this study is to evaluate the safety and tolerability of ANV419 monotherapy followed by ANV419 in combination with lenalidomide plus low-dose dexamethasone or ANV419 in combination with daratumumab.
Detailed Description: The purpose of this multi-site, open-label, Phase 1 adaptive design study is to evaluate the safety, tolerability and preliminary efficacy of ANV419 as a monotherapy followed by ANV419 in combination with lenalidomide plus low-dose dexamethasone or ANV419 in combination with daratumumab in patients aged 18 years or older with with relapsed or refractory Multiple Myeloma.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Vejle Hospital, Vejle, , Denmark
Institut Paoli-Calmettes, Marseille, , France
CHU de Nantes - Hôtel-Dieu, Nantes, , France
Institut de cancérologie Strasbourg Europe (ICANS), Strasbourg, , France
Universitätsklinikum Jena, Jena, , Germany
Hospital Clinic Barcelona, Barcelona, , Spain
Hospital Universitario La Princesa, Madrid, , Spain
Hospital General Universitario Morales Meseguer, Murcia, , Spain
Hospital Clinico Universitario de Salamanca, Salamanca, , Spain
Inselspital, Universitätsspital Bern, Bern, , Switzerland
Kantonsspital St. Gallen, Saint Gallen, , Switzerland
Name: Eduard Gasal, MD
Affiliation: Anaveon AG
Role: STUDY_DIRECTOR