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

Sponsor
Anaveon AG
Study ID
NCT05641324
Phase
PHASE1
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 10, 2023
Status verified
Feb 2024
Primary completion
Jul 12, 2023
Completion
Jul 12, 2023

Study Design

Enrollment
4 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ANV419 single agent, dose 1, Q2W
  • Experimental: ANV419 single agent, dose 2, Q2W
  • Experimental: ANV419 Q2W + Lenalidomide plus low-dose dexamethasone
  • Experimental: ANV419 Q2W + Daratumumab

Primary Outcome Measure

Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) with ANV419 monotherapy [ Time Frame: Day 1 up to 12 months ]

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