NCT05641324

A Study of ANV419 Alone or in Combination With Approved Treatments in Patients With Multiple Myeloma (OMNIA-2)

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)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Anaveon AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma
• Relapsed Cancer
• Refractory Multiple Myeloma
• Adult Disease
• Hematologic Diseases

Interventions

Type	Name	Description
DRUG	ANV419	ANV419 administered by intravenous (IV) infusion
DRUG	Lenalidomide with low-dose dexamethasone	Lenalidomide and dexamethasone administered orally
DRUG	Daratumumab	Daratumumab administered by subcutaneous injection

Timeline

• Start date: 2023-02-10
• Primary completion: 2023-07-12
• Completion: 2023-07-12
• First posted: 2022-12-07
• Last updated: 2024-02-12

Locations

11 sites across 5 countries: Denmark, France, Germany, Spain, Switzerland