A Real-World Study of Bispecific Antibodies in Multiple Myeloma

NCT06359067 | Completed

• 1 other identifier: APHP240295
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Myeloma

Keywords

Multiple myeloma; Teclistamab; Elranatamab; Bispecific antibody

Outcome Measures

Primary Outcomes (1)

• Infection rate

  Explore the infection rate

  Up to 18 months

Secondary Outcomes (2)

• Global survival

  Up to 18 months

• Progression-free survivals

  Up to 18 months

Study Arms (2)

Treated by bispecific antibodies

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

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

Control group

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

Other: Not treated by bispecific antibodies in usual care

Interventions

Treated by bispecific antibodies, teclistamab or elranatamab in usual care OTHER

Treated by bispecific antibodies, teclistamab or elranatamab in usual care

Treated by bispecific antibodies

Not treated by bispecific antibodies in usual care OTHER

Not treated by bispecific antibodies in usual care

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with multiple myeloma treated with bispecific antibodies, teclistamab or elranatamab.

You may qualify if:

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

You may not qualify if:

• \- Patients opposed to the collection of their personal data

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique - Hôpitaux de Paris (AP-HP)

Paris, IDF, 75004, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Study Officials

• Jeremie ZERBIT, PharmD

  Pharmacy Department, Assistance Publique-Hopitaux de Paris, Université de Paris, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 11, 2024
• Study Start: July 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 11, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)