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| ID | Type | Description | Link |
|---|---|---|---|
| 64007957MMY4004 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to describe the use of teclistamab/talquetamab in the treatment of patients with RRMM outside of clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Relapsed/Refractory Multiple Myeloma (RRMM): Teclistamab Cohort 1 | Participants with RRMM who received at least one dose of teclistamab outside of clinical trials on or before 31 December 2022 will be enrolled in the study. The data available from the medical records of each enrolled participant will be the collected to describe the use of teclistamab. |
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| Participants with Relapsed/Refractory Multiple Myeloma (RRMM): Teclistamab Cohort 2 | Participants with RRMM who received at least one dose of teclistamab outside of clinical trials from 01 January 2023 to 31 December 2024, inclusive will be enrolled in the study. The data available from the medical records of each enrolled participant will be the collected to describe the use of teclistamab. |
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| Participants with RRMM: Teclistamab Cohort 3 | Participants with RRMM who received at least one dose of teclistamab outside of clinical trials from 01 January 2025 to 31 December 2025, inclusive will be enrolled in the study. The data available from the medical records of each enrolled participant will be the collected to describe the use of teclistamab. |
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| Participants with RRMM: Talquetamab Cohort | Participants with RRMM who received at least one dose of talquetamab outside of clinical trials on or before 31 December 2023 will be enrolled in the study. The data available from the medical records of each enrolled participant will be collected to describe the use of talquetamab. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teclistamab | Other | No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF. |
| Measure | Description | Time Frame |
|---|---|---|
| Describe Baseline Characteristics of Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who Received Teclistamab/ Talquetamab Outside of Clinical Trials | Participants' demographics and disease characteristics (age, co-morbidities, renal function), and prior antimyeloma therapies will be reported. | Baseline (Day 1) |
| Overall Response Rate (ORR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials | ORR is defined as the percentage of patients who have a PR or better as assessed by investigator per International Myeloma Working Group (IMWG) response criteria. | Up to 40 months |
| Time to First Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials | Time to first response is defined as the time between date of first dose of teclistamab/talquetamab and the date when patient has achieved first response, as assessed by investigator per IMWG response criteria. | Up to 40 months |
| Time to Best Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials | Time to best response is defined as the time between date of first dose of teclistamab/talquetamab and the date of the best response, as assessed by investigator per IMWG response criteria. | Up to 40 months |
| Duration of Response (DOR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials | DOR will be calculated among participants (with a PR or better response) from the date of the first response (PR or better) to the date of first evidence of progressive disease, as assessed by investigator per IMWG response criteria. | Up to 40 months |
| Measure | Description | Time Frame |
|---|---|---|
| Describe the Use of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials | Treatment patterns including healthcare setting and treatment schedules will be reported. | Baseline (Day 1) up to end of treatment (up to 40 months) |
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Inclusion Criteria:
Exclusion Criteria:
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Study population include patients who have initiated the treatment with T-cell redirectors outside of a clinical trial setting.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Limited Clinical Trial | Janssen-Cilag Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Sygehus Syd | Recruiting | Aalborg | 9100 | Denmark | ||
| Aarhus Universitetshospital |
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| Talquetamab | Other | No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF. |
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| Minimal Residue Assessment (MRD) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials | Number of participants with MRD negative rate will be assessed. | Up to 40 months |
| Overall Survival (OS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials | OS is defined as the time from the date of first dose of teclistamab/talquetamab to the date of the participant's death. | From the date of first dose of teclistamab/talquetamab to the date of the participant's death (up to 40 months) |
| Progression Free Survival (PFS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials | PFS is defined as the time from the date of first dose of teclistamab/talquetamab to the date of first evidence of progressive disease, as assessed by investigator per IMWG response criteria, or death due to any cause, whichever occurs first. | Up to 40 months |
| Time to Next Treatment (TTNT) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials | TTNT is defined as the time from the date of first dose of teclistamab/talquetamab to the start of the next line of antimyeloma treatment. | Up to 40 months |
| Describe the Safety Management of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials | Incidence and severity of adverse events (AEs) including immune effector cell-associated neurotoxicity syndrome (ICANS), cytokine release syndrome (CRS) and other AEs as well as medications used for prophylaxis and management of adverse events will be reported. | Baseline (Day 1) up to end of treatment (up to 40 months) |
| Completed |
| Aarhus N |
| 8200 |
| Denmark |
| Rigshospitalet | Completed | Copenhagen | 2100 | Denmark |
| Odense University Hospital | Completed | Odense | 5000 | Denmark |
| Sygehus Lillebælt, Vejle | Recruiting | Vejle | 7100 | Denmark |
| Hopital Albert Calmette - CHU Lille | Recruiting | Lille | 59037 | France |
| Institut Paoli Calmettes | Completed | Marseille | 13009 | France |
| CHU de Nantes hotel Dieu | Recruiting | Nantes | 44000 | France |
| Hopital Saint Louis | Completed | Paris | 75475 | France |
| Institut Universitaire du Cancer Toulouse Oncopole | Recruiting | Toulouse | 31100 | France |
| CHRU de Nancy - Hopitaux de Brabois | Completed | Vandœuvre-lès-Nancy | 54500 | France |
| Klinikum Chemnitz gGmbH | Completed | Chemnitz | 09116 | Germany |
| Universitatsklinikum Carl Gustav Carus Dresden | Completed | Dresden | 01307 | Germany |
| University Hospital Hamburg Eppendorf | Recruiting | Hamburg | 20246 | Germany |
| Klinikum Region Hannover Klinikum Siloah | Recruiting | Hanover | 30459 | Germany |
| Uniklinikum Heidelberg 1 | Completed | Heidelberg | 69120 | Germany |
| Klinikum Nurnberg Nord | Completed | Nuremberg | 90419 | Germany |
| Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii | Recruiting | Würzburg | 97080 | Germany |
| University Hospital of Alexandroupolis | Recruiting | Alexandroupoli | 68100 | Greece |
| Laiko General Hospital of Athens | Recruiting | Athens | 115 27 | Greece |
| Alexandra Hospital | Recruiting | Athens | 115 28 | Greece |
| University Hospital of Crete, PAGNI | Completed | Heraklion | 715 00 | Greece |
| Ioannina University Hospital | Recruiting | Ioannina | 45500 | Greece |
| University Hospital Of Larissa | Recruiting | Larissa | 413 34 | Greece |
| Anticancer Hospital of Thessaloniki Theageneio | Recruiting | Thessaloniki | 546 39 | Greece |
| Ahepa University General Hospital of Thessaloniki | Recruiting | Thessaloniki | 54636 | Greece |
| G Papanikolaou Hospital of Thessaloniki | Recruiting | Thessaloniki | 570 10 | Greece |
| Cork University Hospital | Completed | Cork | 00000 | Ireland |
| Bon Secours Hospital | Completed | Cork | T12 DV56 | Ireland |
| St James Hospital | Completed | Dublin | D08 NHY1 | Ireland |
| Beacon Hospital | Completed | Dublin | D18 AK68 | Ireland |
| University Hospital Galway - Ireland | Completed | Galway | H91 YR71 | Ireland |
| Hadassah Medical Center | Completed | Jerusalem | 9112001 | Israel |
| Sheba Medical Center | Completed | Ramat Gan | 52621 | Israel |
| Tel Aviv Sourasky Medical Center | Completed | Tel Aviv | 6423906 | Israel |
| Policlinico Sant'Orsola Malpighi | Completed | Bologna | 40138 | Italy |
| Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano | Completed | Bolzano | 39100 | Italy |
| Ospedale A.Perrino di Brindisi | Completed | Brindisi | 72100 | Italy |
| AOU Careggi | Completed | Florence | 50141 | Italy |
| Ospedale Vito Fazzi | Completed | Lecce | 73100 | Italy |
| Policlinico di Milano | Completed | Milan | 20121 | Italy |
| IRCCS Istituto Europeo di Oncologia | Completed | Milan | 20252 | Italy |
| Azienda Ospedaliera Universitaria Federico II | Completed | Naples | 80131 | Italy |
| Casa di Cura La Maddalena | Completed | Palermo | 90146 | Italy |
| Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli' | Completed | Roma | 00168 | Italy |
| Presidio Ospedaliero Santo Spirito in Sassia | Completed | Roma | 65124 | Italy |
| Ospedale Andrea Tortora Pagani Salerno | Completed | Salerno | 84098 | Italy |
| Ospedale Ca' Foncello | Completed | Treviso | 31100 | Italy |
| Azienda Sanitaria Universitaria Giuliano Isontina Ospedale Maggiore | Completed | Trieste | 34128 | Italy |
| Ospedale Castelli | Completed | Verbania | 28922 | Italy |
| Ospedale San Bortolo | Completed | Vicenza | 36100 | Italy |
| Akershus Universitetssykehus | Recruiting | Oslo | 1478 | Norway |
| Vestfold Hospital Trust | Recruiting | Tønsberg | 3103 | Norway |
| Hosp. Ntra. Sra. de Sonsoles | Recruiting | Ávila | 05071 | Spain |
| Hosp. Univ. Virgen de Las Nieves | Recruiting | Granada | 18014 | Spain |
| Hosp. Univ. de La Princesa | Recruiting | Madrid | 28006 | Spain |
| Hosp. Univ. de La Paz | Recruiting | Madrid | 28046 | Spain |
| Hosp. Costa Del Sol | Completed | Málaga | 29603 | Spain |
| Hosp. Clinico Univ. de Valencia | Recruiting | Valencia | 46010 | Spain |
| Hosp. Alvaro Cunqueiro | Recruiting | Vigo | 36213 | Spain |
| Sahlgrenska University Hospital | Recruiting | Gothenburg | 413 45 | Sweden |
| Länssjukhuset Ryhov | Completed | Jönköping | 551 85 | Sweden |
| Karolinska Universitetssjukhuset | Recruiting | Stockholms | 12559 | Sweden |
| Uddevalla Hospital | Completed | Uddevalla | 451 98 | Sweden |
| Queen Elizabeth Hospital | Recruiting | Birmingham | B15 2GW | United Kingdom |
| University College Hospital | Recruiting | London | NW1 2PG | United Kingdom |
| Guys and St Thomas NHS Foundation Trust | Completed | London | SE1 9RT | United Kingdom |
| The Royal Wolverhampton Hospitals NHS Trust - New Cross Hosp | Recruiting | Wolverhampton | WV10 0QP | United Kingdom |
| 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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| ID | Term |
|---|---|
| C000730985 | talquetamab |
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