Multiple MyelomaTEC-CARENCT06062537
Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients
An observational study of Multiple Myeloma, run by Intergroupe Francophone du Myelome at 31 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 200 participants
- Where
- 31 sitesFrance
- Study dates
- 19 Sep 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: French adult patient relapsed and refractory multiple myeloma receving teclistamab
Who may be able to join
- Adult patient (≥18 years) with multiple myeloma who will receive at least one dose of teclistamab (first dose of the step-up dose)
Who cannot join
- 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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
France31 sites
CHU Amiens Picardie
Amiens
CH d'ANNECY
Annecy
Centre hospitalier d'Argenteuil
Argenteuil
Hopital de la cote Basque
Bayonne
CHU de Besançon
Besançon
CHU Bordeaux
Bordeaux, 31400
Centre hospitalier de Brive-la-Gaillarde
Brive-la-Gaillarde
CHU CAEN
Caen
Centre hospitalier Métropole de Savoie
Chambéry
CHU Clermont-Ferrand Site Estaing
Clermont-Ferrand
CHU Henri Mondor
Créteil
Chu Dijon
Dijon
CH Dunkerque
Dunkirk
CHU de Lille
Lille
Groupe hospitalier Bretagne Sud
Lorient
Institut Paoli Calmette
Marseille
CH de METZ
Metz
CHU Saint-Eloi - CHU de Montpellier
Montpellier
Chu de Nantes
Nantes
CHU de Nice
Nice
Hopital Necker
Paris
Hopital saint louis
Paris
CH Perpignan
Perpignan
Hopital Novo
Pontoise
Chu de Rennes
Rennes
Centre Henri Becquerel
Rouen
Institut de Cancérologie Lucien Neuwirth, CHU Saint-Etienne
Saint-Priest-en-Jarez
Hopital de Hautepierre
Strasbourg
CHU Toulouse
Toulouse
CHU de Tours
Tours
CH Bretagne Atlantique
Vannes
About this study
Official title: Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients: a Collaborative Janssen - IFM Study IFM 2023-01: TEC-CARE
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.
- Conditions
- Multiple Myeloma
- Keywords
- teclistamab, refractory multiple myeloma, real word evidence study
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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.
Measured: 24 months
Secondary outcomes (10)
Effectiveness of teclistamab
Progression Free Survival 1 and 2 (PFS)
Measured: 24 months
Effectiveness of teclistamab
Overall survival (OS)
Measured: 24 months
Effectiveness of teclistamab
Duration of overall response (DOR)
Measured: 24 months
Effectiveness of teclistamab
Response rate (sCR, CR, VGPR, PR)
Measured: 24 months
Effectiveness of teclistamab
Time to best response
Measured: 24 months
Effectiveness of teclistamab
Time to next treatment (TTNT)
Measured: 24 months
Effectiveness of teclistamab
Time to discontinuation (TTD)
Measured: 24 months
Adverse events of interest
ICANS, CSR and infections
Measured: 24 months
Conditions of use
Patients' profiles (demographics characteristics and medical history)
- Injection facilities and schedules during step-up dosing phase
Measured: 1 month
Conditions of use
Patients' profiles (demographics characteristics and medical history)
- Injection facilities and schedules during follow up phase
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start19 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone du Myelome
- Sponsor type
- Research network
- Collaborators
- Janssen-Cilag Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062537
- Sponsor's protocol ID
- IFM 2023-01
- Acronym
- TEC-CARE
- Status last verified
- Apr 2026
- First submitted
- 22 Sep 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients: a Collaborative Janssen - IFM Study IFM 2023-01: TEC-CARE
- ClinicalTrials.gov ID
- NCT06062537
- Acronym / sponsor ID
- TEC-CARE / IFM 2023-01
- Conditions
- Multiple Myeloma
- Keywords
- teclistamab, refractory multiple myeloma, real word evidence study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Intergroupe Francophone du MyelomeResearch network
- Collaborators
- Janssen-Cilag Ltd.
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- French adult patient relapsed and refractory multiple myeloma receving teclistamab
Key inclusion criteria (1 listed)
- Adult patient (≥18 years) with multiple myeloma who will receive at least one dose of teclistamab (first dose of the step-up dose)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall response rate (ORR) of teclistamab according to IMWG criteria
Time frame: 6 months
ORR is defined as the proportion of subjects who achieve a PR or better according to IMWG criteria.
overall response rate (ORR) of teclistamab according to IMWG criteria
Time frame: 24 months
ORR is defined as the proportion of subjects who achieve a PR or better according to IMWG criteria.
10 secondary outcomes
Effectiveness of teclistamab
Time frame: 24 months
Effectiveness of teclistamab
Time frame: 24 months
Effectiveness of teclistamab
Time frame: 24 months
Effectiveness of teclistamab
Time frame: 24 months
Effectiveness of teclistamab
Time frame: 24 months
Effectiveness of teclistamab
Time frame: 24 months
Effectiveness of teclistamab
Time frame: 24 months
Adverse events of interest
Time frame: 24 months
Conditions of use
Time frame: 1 month
Conditions of use
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Intergroupe Francophone du Myelome at 31 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (ORR) of teclistamab according to IMWG criteria (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.