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NCT Number: NCT06359067

A Real-World Study of Bispecific Antibodies in Multiple Myeloma

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).

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique - Hôpitaux de Paris (AP-HP)

Paris, IDF, 75004, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treated by bispecific antibodies, teclistamab or elranatamab in usual care

Other

Treated by bispecific antibodies, teclistamab or elranatamab in usual care

Not treated by bispecific antibodies in usual care

Other

Not treated by bispecific antibodies in usual care

Primary outcomes

  1. Infection rate

    Time frame: Up to 18 months

    Explore the infection rate

Secondary outcomes

  1. Global survival

    Time frame: Up to 18 months

    Explore the global survival

  2. Progression-free survivals

    Time frame: Up to 18 months

    Explore the progression-free survivals

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: BISPEMM

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2024
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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