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| Name | Class |
|---|---|
| Janssen-Cilag Ltd. | INDUSTRY |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of teclistamab | Progression Free Survival 1 and 2 (PFS) | 24 months |
| Effectiveness of teclistamab | Overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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French adult patient relapsed and refractory multiple myeloma receving teclistamab
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Picardie | Amiens | France | ||||
| CH d'ANNECY |
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| 24 months |
| Effectiveness of teclistamab | Duration of overall response (DOR) | 24 months |
| Effectiveness of teclistamab | Response rate (sCR, CR, VGPR, PR) | 24 months |
| Effectiveness of teclistamab | Time to best response | 24 months |
| Effectiveness of teclistamab | Time to next treatment (TTNT) | 24 months |
| Effectiveness of teclistamab | Time to discontinuation (TTD) | 24 months |
| Adverse events of interest | ICANS, CSR and infections | 24 months |
| Conditions of use | Patients' profiles (demographics characteristics and medical history) - Injection facilities and schedules during step-up dosing phase | 1 month |
| Conditions of use | Patients' profiles (demographics characteristics and medical history) - Injection facilities and schedules during follow up phase | 24 months |
| 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 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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