A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials
NCT ID: NCT06285318
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
900 participants
OBSERVATIONAL
2023-12-18
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
Teclistamab
No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.
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.
Teclistamab
No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.
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.
Teclistamab
No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.
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.
Talquetamab
No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.
Interventions
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Teclistamab
No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.
Talquetamab
No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Received the first dose of teclistamab on or before 31 December 2022, regardless of the duration of teclistamab treatment (REALiTEC cohort 1) OR Received the first dose of teclistamab from 01 January 2023 to 31 December 2024, inclusive, regardless of the duration of teclistamab treatment (REALiTEC cohort 2) OR Received the first dose of teclistamab from 01 January 2025 to 31 December 2025, inclusive, regardless of the duration of teclistamab treatment (REALiTEC cohort 3) OR Received the first dose of talquetamab on or before 31 December 2023, regardless of the duration of talquetamab treatment (REALiTAL cohort). Participants who received both teclistamab \& talquetamab can be included in both REALiTEC and REALiTAL cohorts
* Received at least one dose of teclistamab/talquetamab
* Provision of a patient-signed informed consent form (ICF), or an ICF waiver for deceased patients as applicable based on country/site-specific requirements
Exclusion Criteria
* To be excluded from REALiTAL cohort if received talquetamab as part of an interventional clinical trial
* Participants who have received teclistamab as part of a Janssen pre-approval access program are excluded from the REALiTEC Cohort 2 and REALiTEC Cohort 3
18 Years
ALL
No
Sponsors
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Janssen-Cilag Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen-Cilag Limited Clinical Trial
Role: STUDY_DIRECTOR
Janssen-Cilag Limited
Locations
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Aalborg Sygehus Syd
Aalborg, , Denmark
Aarhus Universitetshospital
Aarhus N, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Odense University Hospital
Odense, , Denmark
Sygehus Lillebælt, Vejle
Vejle, , Denmark
Hopital Albert Calmette - CHU Lille
Lille, , France
Institut Paoli Calmettes
Marseille, , France
CHU de Nantes hotel Dieu
Nantes, , France
Hopital Saint Louis
Paris, , France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, , France
CHRU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy, , France
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
University Hospital Hamburg Eppendorf
Hamburg, , Germany
Klinikum Region Hannover Klinikum Siloah
Hanover, , Germany
Uniklinikum Heidelberg
Heidelberg, , Germany
Klinikum Nurnberg Nord
Nuremberg, , Germany
Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii
Würzburg, , Germany
University Hospital of Alexandroupolis
Alexandroupoli, , Greece
Laiko General Hospital of Athens
Athens, , Greece
Alexandra Hospital
Athens, , Greece
University Hospital of Crete, PAGNI
Heraklion, , Greece
Ioannina University Hospital
Ioannina, , Greece
University Hospital Of Larissa
Larissa, , Greece
Anticancer Hospital of Thessaloniki Theageneio
Thessaloniki, , Greece
Ahepa University General Hospital of Thessaloniki
Thessaloniki, , Greece
G Papanikolaou Hospital of Thessaloniki
Thessaloniki, , Greece
Cork University Hospital
Cork, , Ireland
Bon Secours Hospital
Cork, , Ireland
St James Hospital
Dublin, , Ireland
Beacon Hospital
Dublin, , Ireland
University Hospital Galway - Ireland
Galway, , Ireland
Hadassah Medical Center
Jerusalem, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Policlinico Sant'Orsola Malpighi
Bologna, , Italy
Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano
Bolzano, , Italy
Ospedale A.Perrino di Brindisi
Brindisi, , Italy
AOU Careggi
Florence, , Italy
Ospedale Vito Fazzi
Lecce, , Italy
Policlinico di Milano
Milan, , Italy
IRCCS Istituto Europeo di Oncologia
Milan, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Casa di Cura La Maddalena
Palermo, , Italy
Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'
Roma, , Italy
Presidio Ospedaliero Santo Spirito in Sassia
Roma, , Italy
Ospedale Andrea Tortora Pagani Salerno
Salerno, , Italy
Ospedale Ca' Foncello
Treviso, , Italy
Azienda Sanitaria Universitaria Giuliano Isontina Ospedale Maggiore
Trieste, , Italy
Ospedale Castelli
Verbania, , Italy
Ospedale San Bortolo
Vicenza, , Italy
Akershus Universitetssykehus
Oslo, , Norway
Vestfold Hospital Trust
Tønsberg, , Norway
Hosp. Ntra. Sra. de Sonsoles
Ávila, , Spain
Hosp. Univ. Virgen de Las Nieves
Granada, , Spain
Hosp. Univ. de La Princesa
Madrid, , Spain
Hosp. Univ. de La Paz
Madrid, , Spain
Hosp. Costa Del Sol
Málaga, , Spain
Hosp. Clinico Univ. de Valencia
Valencia, , Spain
Hosp. Alvaro Cunqueiro
Vigo, , Spain
Sahlgrenska University Hospital
Gothenburg, , Sweden
Länssjukhuset Ryhov
Jönköping, , Sweden
Karolinska Universitetssjukhuset
Stockholms, , Sweden
Uddevalla Hospital
Uddevalla, , Sweden
Queen Elizabeth Hospital
Birmingham, , United Kingdom
University College Hospital
London, , United Kingdom
Guys and St Thomas NHS Foundation Trust
London, , United Kingdom
The Royal Wolverhampton Hospitals NHS Trust - New Cross Hosp
Wolverhampton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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64007957MMY4004
Identifier Type: OTHER
Identifier Source: secondary_id
64007957MMY4004
Identifier Type: -
Identifier Source: org_study_id