Trial intelligence / Profile preview

Isatuximab Treatment Extension Study in Multiple Myeloma

NCT05669989Phase 2

Key facts

Status
Enrolling by invitation
Start
Apr 2023
Primary completion
Nov 2028
Countries
17
Sponsor
Sanofi
Modality
Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
Conditions
multiple myeloma (MM)
01

Overview

Phase 2, open-label, single-arm trial of isatuximab in multiple myeloma (MM), sponsored by Sanofi. Primary endpoint: Number of participants with treatment-emergent adverse events at 42 months. Started Apr 2023; status: enrolling by invitation.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Isatuximab

    Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the participant received on the parental protocol.

03

Who it enrols

Adult patients with multiple myeloma who completed a parental isatuximab study, are still benefiting from isatuximab, have no evidence of progressive disease, and have recovered from prior therapy toxicities.

04

Endpoints

Primary

  • Number of participants with treatment-emergent adverse events

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