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Safety and effectiveness of isatuximab injection

Long-term follow-up study of isatuximab injection

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102247
Enrollment
Unknown
Registered
2025-05-12
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Interventions

Observation Group:None

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 95 Years

Inclusion criteria

Inclusion criteria: 1.Have received Isatuximab injection; 2.Subjects are required to complete or withdraw early from the original study if involved in pre-marketing clinical research or post-marketing real-world studies of Ikigulon injection. 3.Voluntarily sign the informed consent form approved by the ethics committee.

Exclusion criteria

Exclusion criteria: Patients who received another lentiviral vector-based cell or gene therapy (whether a commercial product or an investigational drug from a clinical trial) between the reinfusion of Isatuximab Injection and the signing of the informed consent form

Design outcomes

Primary

MeasureTime frame
Safety profiles after Equecabtagene autoleucel Injection treatment;—

Secondary

MeasureTime frame
Overall survival, OS;VCN (Vector copy number) detection;Progression-free survival, PFS;—

Countries

China

Contacts

Public ContactJian Li

Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences

lijian@pumch.cn+86 10 69155027

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026