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Active, not recruitingNCT06062537TEC-CAREUpdated Apr 13, 2026

Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients

An observational study in Multiple Myeloma, sponsored by Intergroupe Francophone du Myelome. Active, not recruiting at 31 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Intergroupe Francophone du Myelome · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

200 adult patients with multiple myeloma receiving teclistamb will be included. Effectiveness, safety, and condition of use of teclistamab in early access program (post-MA) will be assessed. Primary objective is the evaluation of overall response rate (ORR) of teclistamab according to IMWG criteria.

This is a multicenter, prospective, observational study.

02

Conditions studied

  • Multiple Myeloma

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Keywords

  • teclistamab
  • refractory multiple myeloma
  • real word evidence study
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

French adult patient relapsed and refractory multiple myeloma receving teclistamab

Inclusion criteria

  • Adult patient (≥18 years) with multiple myeloma who will receive at least one dose of teclistamab (first dose of the step-up dose)

Exclusion criteria

Exclusion Criteria:

  • Patients alive at the start of the study who did not receive study information or who objected to the collection of data
  • Patients who received teclistamab as part of an interventional clinical trial
  • Patients who are initiating teclistamab as part of a current interventional clinical trial
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. overall response rate (ORR) of teclistamab according to IMWG criteria

    ORR is defined as the proportion of subjects who achieve a PR or better according to IMWG criteria.

    Time frame: 6 months

  2. overall response rate (ORR) of teclistamab according to IMWG criteria

    ORR is defined as the proportion of subjects who achieve a PR or better according to IMWG criteria.

    Time frame: 24 months

Secondary outcomes

  1. Effectiveness of teclistamab

    Progression Free Survival 1 and 2 (PFS)

    Time frame: 24 months

  2. Effectiveness of teclistamab

    Overall survival (OS)

    Time frame: 24 months

  3. Effectiveness of teclistamab

    Duration of overall response (DOR)

    Time frame: 24 months

  4. Effectiveness of teclistamab

    Response rate (sCR, CR, VGPR, PR)

    Time frame: 24 months

  5. Effectiveness of teclistamab

    Time to best response

    Time frame: 24 months

  6. Effectiveness of teclistamab

    Time to next treatment (TTNT)

    Time frame: 24 months

  7. Effectiveness of teclistamab

    Time to discontinuation (TTD)

    Time frame: 24 months

  8. Adverse events of interest

    ICANS, CSR and infections

    Time frame: 24 months

  9. Conditions of use

    Patients' profiles (demographics characteristics and medical history) \- Injection facilities and schedules during step-up dosing phase

    Time frame: 1 month

  10. Conditions of use

    Patients' profiles (demographics characteristics and medical history) \- Injection facilities and schedules during follow up phase

    Time frame: 24 months

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Study locations

31 sites
  • CHU Amiens Picardie
    Amiens, France
  • CH d'ANNECY
    Annecy, France
  • Centre hospitalier d'Argenteuil
    Argenteuil, France
  • Hopital de la cote Basque
    Bayonne, France
  • CHU de Besançon
    Besançon, France
  • CHU Bordeaux
    Bordeaux, 31400, France
  • Centre hospitalier de Brive-la-Gaillarde
    Brive-la-Gaillarde, France
  • CHU CAEN
    Caen, France
  • Centre hospitalier Métropole de Savoie
    Chambéry, France
  • CHU Clermont-Ferrand Site Estaing
    Clermont-Ferrand, France
  • CHU Henri Mondor
    Créteil, France
  • Chu Dijon
    Dijon, France
  • CH Dunkerque
    Dunkirk, France
  • CHU de Lille
    Lille, France
  • Groupe hospitalier Bretagne Sud
    Lorient, France
  • Institut Paoli Calmette
    Marseille, France
  • CH de METZ
    Metz, France
  • CHU Saint-Eloi - CHU de Montpellier
    Montpellier, France
  • Chu de Nantes
    Nantes, France
  • CHU de Nice
    Nice, France
  • Hopital Necker
    Paris, France
  • Hopital saint louis
    Paris, France
  • CH Perpignan
    Perpignan, France
  • Hopital Novo
    Pontoise, France
  • Chu de Rennes
    Rennes, France
  • Centre Henri Becquerel
    Rouen, France
  • Institut de Cancérologie Lucien Neuwirth, CHU Saint-Etienne
    Saint-Priest-en-Jarez, France
  • Hopital de Hautepierre
    Strasbourg, France
  • CHU Toulouse
    Toulouse, France
  • CHU de Tours
    Tours, France
  • CH Bretagne Atlantique
    Vannes, France
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Registry details

Key details

Study ID
NCT06062537
Lead sponsor
Intergroupe Francophone du Myelome
Collaborators
Janssen-Cilag Ltd.
Responsible party
Sponsor
First posted
Oct 2, 2023
Start date
Sep 19, 2023
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Apr 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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