A Real-World Study of Bispecific Antibodies in Multiple Myeloma (BISPEMM)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Multiple Myeloma

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

Study type: Observational

Funder types: Other

Identifiers

NCT06359067

APHP240295

Details and patient eligibility

About

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).

Full 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).

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 2 patient groups

Treated by bispecific antibodies

Description:

Patients with multiple myeloma, penta-drug or triple class refractory and treated by bispecific antibodies, teclistamab or elranatamab

Treatment:

Other: Treated by bispecific antibodies, teclistamab or elranatamab in usual care

Control group

Description:

Patients with multiple myeloma, penta-drug or triple class refractory and not treated by bispecific antibodies

Treatment:

Other: Not treated by bispecific antibodies in usual care