Clinical trial Recruiting at 29 sites Observational Ages 18 and up

Examining outcomes in patients with relapsed/refractory multiple myeloma treated with T-cell redirectors

Official title: 64007957MMY4004: 64007957MMY4004 - REALiTEC

Run by Janssen-Cilag Ltd. · NCT06285318 · Data updated 2026-11-12

This study looks at how well T-cell redirectors like teclistamab and talquetamab work for people with relapsed or refractory multiple myeloma who have been treated outside of clinical trials.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment900 (estimated)
SponsorJanssen-Cilag Ltd.
Industry-sponsored
Drugs / interventionsteclistamab, talquetamab
Locations68 sites (Aalborg and 67 other locations)
StatusRecruiting
StartedDecember 18, 2023
Main results expectedAugust 30, 2026
Study endsSeptember 24, 2026
Registry record updatedAugust 28, 2026
Trial IDNCT06285318 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients with a documented diagnosis of multiple myeloma who have received teclistamab or talquetamab.

Probably not a fit

Patients who have received teclistamab as part of an interventional clinical trial will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to describe the clinical outcomes of patients with relapsed/refractory multiple myeloma (RRMM) who have been treated with T-cell redirectors, specifically teclistamab and talquetamab, outside of clinical trials. It includes patients who received these treatments at various times, allowing for a comprehensive analysis of their effectiveness and safety in real-world settings. The study will gather data on patient responses and outcomes to better understand the impact of these therapies on RRMM.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of teclistamab and talquetamab, potentially improving treatment strategies for patients with RRMM.

How similar studies have gone: While this study focuses on real-world outcomes, similar studies have shown promise in evaluating the effectiveness of T-cell redirectors in treating multiple myeloma.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

  • Aalborg Sygehus Syd
    Aalborg, Denmark
    Recruiting
  • Sygehus Lillebælt, Vejle
    Vejle, Denmark
    Recruiting
  • Hopital Albert Calmette - CHU Lille
    Lille, France
    Recruiting
  • CHU de Nantes hotel Dieu
    Nantes, France
    Recruiting
  • Institut Universitaire du Cancer Toulouse Oncopole
    Toulouse, France
    Recruiting
  • University Hospital Hamburg Eppendorf
    Hamburg, Germany
    Recruiting
Show 44 more locations
  • Klinikum Region Hannover Klinikum Siloah
    Hanover, Germany
    Recruiting
  • Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii
    Würzburg, Germany
    Recruiting
  • University Hospital of Alexandroupolis
    Alexandroupoli, Greece
    Recruiting
  • Laiko General Hospital of Athens
    Athens, Greece
    Recruiting
  • Alexandra Hospital
    Athens, Greece
    Recruiting
  • Ioannina University Hospital
    Ioannina, Greece
    Recruiting
  • University Hospital Of Larissa
    Larissa, Greece
    Recruiting
  • Anticancer Hospital of Thessaloniki Theageneio
    Thessaloniki, Greece
    Recruiting
  • Ahepa University General Hospital of Thessaloniki
    Thessaloniki, Greece
    Recruiting
  • G Papanikolaou Hospital of Thessaloniki
    Thessaloniki, Greece
    Recruiting
  • Akershus Universitetssykehus
    Oslo, Norway
    Recruiting
  • Vestfold Hospital Trust
    Tønsberg, Norway
    Recruiting
  • Hosp. Ntra. Sra. de Sonsoles
    Ávila, Spain
    Recruiting
  • Hosp. Univ. Virgen de Las Nieves
    Granada, Spain
    Recruiting
  • Hosp. Univ. de La Princesa
    Madrid, Spain
    Recruiting
  • Hosp. Univ. de La Paz
    Madrid, Spain
    Recruiting
  • Hosp. Clinico Univ. de Valencia
    Valencia, Spain
    Recruiting
  • Hosp. Alvaro Cunqueiro
    Vigo, Spain
    Recruiting
  • Sahlgrenska University Hospital
    Gothenburg, Sweden
    Recruiting
  • Karolinska Universitetssjukhuset
    Stockholms, Sweden
    Recruiting
  • Queen Elizabeth Hospital
    Birmingham, United Kingdom
    Recruiting
  • University College Hospital
    London, United Kingdom
    Recruiting
  • The Royal Wolverhampton Hospitals NHS Trust - New Cross Hosp
    Wolverhampton, United Kingdom
    Recruiting
  • Aarhus Universitetshospital
    Aarhus N, Denmark
    Completed
  • Rigshospitalet
    Copenhagen, Denmark
    Completed
  • Odense University Hospital
    Odense, Denmark
    Completed
  • Institut Paoli Calmettes
    Marseille, France
    Completed
  • Hopital Saint Louis
    Paris, France
    Completed
  • CHRU de Nancy - Hopitaux de Brabois
    Vandœuvre-lès-Nancy, France
    Completed
  • Klinikum Chemnitz gGmbH
    Chemnitz, Germany
    Completed
  • Universitatsklinikum Carl Gustav Carus Dresden
    Dresden, Germany
    Completed
  • Uniklinikum Heidelberg 1
    Heidelberg, Germany
    Completed
  • Klinikum Nurnberg Nord
    Nuremberg, Germany
    Completed
  • University Hospital of Crete, PAGNI
    Heraklion, Greece
    Completed
  • Cork University Hospital
    Cork, Ireland
    Completed
  • Bon Secours Hospital
    Cork, Ireland
    Completed
  • St James Hospital
    Dublin, Ireland
    Completed
  • Beacon Hospital
    Dublin, Ireland
    Completed
  • University Hospital Galway - Ireland
    Galway, Ireland
    Completed
  • Hadassah Medical Center
    Jerusalem, Israel
    Completed
  • Sheba Medical Center
    Ramat Gan, Israel
    Completed
  • Tel Aviv Sourasky Medical Center
    Tel Aviv, Israel
    Completed
  • Policlinico Sant'Orsola Malpighi
    Bologna, Italy
    Completed
  • Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano
    Bolzano, Italy
    Completed

+18 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.