A Real-World Study of Bispecific Antibodies in Multiple Myeloma

Completed

• Conditions: Multiple Myeloma
• Interventions: Other: Not treated by bispecific antibodies in usual care; Other: Treated by bispecific antibodies, teclistamab or elranatamab in usual care

• Registration Number: NCT06359067
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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).

Detailed 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).

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-04-08
• Last Update Submitted: 2024-04-08
• Study First Posted: 2024-04-11
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Adult ≥ 18 years old
• Patients with multiple myeloma
• Patients who received at least one administration of the following therapies: teclistamab, elranatamab

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Exclusion Criteria

• Patients opposed to the collection of their personal data

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Not treated by bispecific antibodies in usual care	Patients with multiple myeloma, penta-drug or triple class refractory and not treated by bispecific antibodies
Treated by bispecific antibodies	Treated by bispecific antibodies, teclistamab or elranatamab in usual care	Patients with multiple myeloma, penta-drug or triple class refractory and treated by bispecific antibodies, teclistamab or elranatamab

Primary Outcome Measures

Name	Time	Method
Infection rate	Up to 18 months	Explore the infection rate

Secondary Outcome Measures

Name	Time	Method
Progression-free survivals	Up to 18 months	Explore the progression-free survivals
Global survival	Up to 18 months	Explore the global survival

Trial Locations

Locations (1)

Assistance Publique - Hôpitaux de Paris (AP-HP); 🇫🇷 Paris, IDF, France