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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 900 (estimated) |
| Sponsor | Janssen-Cilag Ltd. Industry-sponsored |
| Drugs / interventions | teclistamab, talquetamab |
| Locations | 68 sites (Aalborg and 67 other locations) |
| Status | Recruiting |
| Started | December 18, 2023 |
| Main results expected | August 30, 2026 |
| Study ends | September 24, 2026 |
| Registry record updated | August 28, 2026 |
| Trial ID | NCT06285318 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
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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
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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
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Linvoseltamab with pre-dose Tocilizumab to reduce CRS in adults with relapsed/refractory multiple myeloma
This study tests whether giving tocilizumab before the first dose of linvoseltamab can lower the risk of cytokine release syndrome in adults with relapsed/refractory multiple myeloma who have had at least four prior therapies.
-
Epunamin plus DECP for relapsed or refractory multiple myeloma
This will test whether adding Epunamin to a DECP chemotherapy regimen helps people with relapsed or refractory multiple myeloma have better treatment responses.
-
IASO206 injection for relapsed or refractory multiple myeloma
A single-arm early study is testing IASO206 injection to see if it is safe and tolerable for adults with relapsed or refractory multiple myeloma who have tried at least two prior therapies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.