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

April 8, 2024 updated by: Assistance Publique - Hôpitaux de Paris

A Real-World Study of Bispecific Antibodies, Teclistamab and Elranatamab, for Patients With 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • IDF
      • Paris, IDF, France, 75004
        • Assistance Publique - Hôpitaux de Paris (AP-HP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Not treated by bispecific antibodies in usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection rate
Time Frame: Up to 18 months
Explore the infection rate
Up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global survival
Time Frame: Up to 18 months
Explore the global survival
Up to 18 months
Progression-free survivals
Time Frame: Up to 18 months
Explore the progression-free survivals
Up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Jeremie ZERBIT, PharmD, Pharmacy Department, Assistance Publique-Hopitaux de Paris, Université de Paris, Paris, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP240295

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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