Multiple Myeloma Clinical Trial
— TEC-CAREOfficial 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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | September 2026 |
| Est. primary completion date | September 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CH d'ANNECY | Annecy | |
| France | Hopital de la cote Basque | Bayonne | |
| France | CHU Bordeaux | Bordeaux | |
| France | CHU CAEN | Caen | |
| France | Chu Dijon | Dijon | |
| France | CH Dunkerque | Dunkerque | |
| France | CHU de Lille | Lille | |
| France | CHU de Lyon | Lyon | |
| France | Institut Paoli Calmette | Marseille | |
| France | CH de METZ | Metz | |
| 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 | CHU Toulouse | Toulouse | |
| France | CHU de Tours | Tours | |
| France | CH Bretagne Atlantique | Vannes |
| Lead Sponsor | Collaborator |
|---|---|
| Intergroupe Francophone du Myelome | Janssen-Cilag Ltd. |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 6 months | |
| Primary | 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. | 24 months | |
| Secondary | Effectiveness of teclistamab | Progression Free Survival 1 and 2 (PFS) | 24 months | |
| Secondary | Effectiveness of teclistamab | Overall survival (OS) | 24 months | |
| Secondary | Effectiveness of teclistamab | Duration of overall response (DOR) | 24 months | |
| Secondary | Effectiveness of teclistamab | Response rate (sCR, CR, VGPR, PR) | 24 months | |
| Secondary | Effectiveness of teclistamab | Time to best response | 24 months | |
| Secondary | Effectiveness of teclistamab | Time to next treatment (TTNT) | 24 months | |
| Secondary | Effectiveness of teclistamab | Time to discontinuation (TTD) | 24 months | |
| Secondary | Adverse events of interest | ICANS, CSR and infections | 24 months | |
| Secondary | Conditions of use | Patients' profiles (demographics characteristics and medical history)
- Injection facilities and schedules during step-up dosing phase |
1 month | |
| Secondary | Conditions of use | Patients' profiles (demographics characteristics and medical history)
- Injection facilities and schedules during follow up phase |
24 months |
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