TEC-CARE: Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- overall response rate (ORR) of teclistamab according to IMWG criteria [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 [24 months]
ORR is defined as the proportion of subjects who achieve a PR or better according to IMWG criteria.
Secondary Outcome Measures
- Effectiveness of teclistamab [24 months]
Progression Free Survival 1 and 2 (PFS)
- Effectiveness of teclistamab [24 months]
Overall survival (OS)
- Effectiveness of teclistamab [24 months]
Duration of overall response (DOR)
- Effectiveness of teclistamab [24 months]
Response rate (sCR, CR, VGPR, PR)
- Effectiveness of teclistamab [24 months]
Time to best response
- Effectiveness of teclistamab [24 months]
Time to next treatment (TTNT)
- Effectiveness of teclistamab [24 months]
Time to discontinuation (TTD)
- Adverse events of interest [24 months]
ICANS, CSR and infections
- Conditions of use [1 month]
Patients' profiles (demographics characteristics and medical history) - Injection facilities and schedules during step-up dosing phase
- Conditions of use [24 months]
Patients' profiles (demographics characteristics and medical history) - Injection facilities and schedules during follow up phase
Eligibility Criteria
Criteria
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:
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Patients alive at the start of the study who did not receive study information or who objected to the collection of data
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Patients who received teclistamab as part of an interventional clinical trial
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Patients who are initiating teclistamab as part of a current interventional clinical trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CH d'ANNECY | Annecy | France | ||
| 2 | Hopital de la cote Basque | Bayonne | France | ||
| 3 | CHU Bordeaux | Bordeaux | France | 31400 | |
| 4 | CHU CAEN | Caen | France | ||
| 5 | Chu Dijon | Dijon | France | ||
| 6 | CH Dunkerque | Dunkerque | France | ||
| 7 | CHU de Lille | Lille | France | ||
| 8 | CHU de Lyon | Lyon | France | ||
| 9 | Institut Paoli Calmette | Marseille | France | ||
| 10 | CH de METZ | Metz | France | ||
| 11 | Chu de Nantes | Nantes | France | ||
| 12 | CHU de Nice | Nice | France | ||
| 13 | Hopital Necker | Paris | France | ||
| 14 | Hopital saint louis | Paris | France | ||
| 15 | CH Perpignan | Perpignan | France | ||
| 16 | Hopital Novo | Pontoise | France | ||
| 17 | Chu de Rennes | Rennes | France | ||
| 18 | CHU Toulouse | Toulouse | France | ||
| 19 | CHU de Tours | Tours | France | ||
| 20 | CH Bretagne Atlantique | Vannes | France |
Sponsors and Collaborators
- Intergroupe Francophone du Myelome
- Janssen-Cilag Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IFM 2023-01