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NCT06359067 Clinical Trial

A Real-World Study of Bispecific Antibodies in Multiple Myeloma

Multiple Myeloma Clinical Trial

— BISPEMM  

Official title:
A Real-World Study of Bispecific Antibodies, Teclistamab and Elranatamab, for Patients With Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06359067
Other study ID # APHP240295
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date December 31, 2023

Study information
Verified date March 2024
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Bispecific antibody (BsAb) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. The results are very encouraging but complicated adverse events, particularly infectious. This study analyzes survival data in patients treated with BsAb, as well as safety data, in particular the proportions and locations of infectious events. The results are compared to a control cohort. This study is multicentric on all the university hospitals of Paris (AP-HP).

Description:

Bispecific antibody (BsAb) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. The results are very encouraging but complicated adverse events, particularly infectious. This study analyzes survival data in patients treated with BsAb, as well as safety data, in particular the proportions and locations of infectious events. The results are compared to a control cohort. This study is multicentric on all the university hospitals of Paris (AP-HP).

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult = 18 years old - Patients with multiple myeloma - Patients who received at least one administration of the following therapies: teclistamab, elranatamab Exclusion Criteria: - Patients opposed to the collection of their personal data

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Treated by bispecific antibodies, teclistamab or elranatamab in usual care
Treated by bispecific antibodies, teclistamab or elranatamab in usual care
• Not treated by bispecific antibodies in usual care
Not treated by bispecific antibodies in usual care

Locations
Country Name City State
France Assistance Publique - Hôpitaux de Paris (AP-HP) Paris IDF

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Infection rate Explore the infection rate Up to 18 months
Secondary Global survival Explore the global survival Up to 18 months
Secondary Progression-free survivals Explore the progression-free survivals Up to 18 months
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