RecruitingNCT06285318

A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials

A Retrospective, Multicountry Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma Treated With T-cell Redirectors Outside of Clinical Trials


Sponsor

Janssen-Cilag Ltd.

Enrollment

900 participants

Start Date

Dec 18, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to describe the use of teclistamab/talquetamab in the treatment of patients with RRMM outside of clinical trials.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Have a documented diagnosis of multiple myeloma
  • 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 Criteria3

  • To be excluded from REALiTEC cohorts if received teclistamab as part of an interventional clinical trial
  • 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

Interventions

OTHERTeclistamab

No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.

OTHERTalquetamab

No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.


Locations(68)

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

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NCT06285318


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