Examining outcomes in patients with relapsed/refractory multiple myeloma treated with T-cell redirectors
A Retrospective, Multicountry Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma Treated With T-cell Redirectors Outside of Clinical Trials
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 |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen-Cilag Ltd. Industry-sponsored |
| Drugs / interventions | teclistamab, talquetamab |
| Locations | 68 sites (Aalborg and 67 other locations) |
| Trial ID | NCT06285318 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with a documented diagnosis of multiple myeloma who have received teclistamab or talquetamab.
Not a fit: Patients who have received teclistamab as part of an interventional clinical trial will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Aalborg and 67 other locations
- Aalborg Sygehus Syd — Aalborg, Denmark (Recruiting)
- Aarhus Universitetshospital — Aarhus N, Denmark (Completed)
- Rigshospitalet — Copenhagen, Denmark (Completed)
- Odense University Hospital — Odense, Denmark (Completed)
- Sygehus Lillebælt, Vejle — Vejle, Denmark (Recruiting)
- Hopital Albert Calmette - CHU Lille — Lille, France (Recruiting)
- Institut Paoli Calmettes — Marseille, France (Completed)
- CHU de Nantes hotel Dieu — Nantes, France (Recruiting)
- Hopital Saint Louis — Paris, France (Completed)
- Institut Universitaire du Cancer Toulouse Oncopole — Toulouse, France (Recruiting)
- 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)
- University Hospital Hamburg Eppendorf — Hamburg, Germany (Recruiting)
- Klinikum Region Hannover Klinikum Siloah — Hanover, Germany (Recruiting)
- Uniklinikum Heidelberg 1 — Heidelberg, Germany (Completed)
- Klinikum Nurnberg Nord — Nuremberg, Germany (Completed)
- 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)
- University Hospital of Crete, PAGNI — Heraklion, Greece (Completed)
- 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)
- 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)
- Ospedale A.Perrino di Brindisi — Brindisi, Italy (Completed)
- AOU Careggi — Florence, Italy (Completed)
- Ospedale Vito Fazzi — Lecce, Italy (Completed)
- Policlinico di Milano — Milan, Italy (Completed)
- IRCCS Istituto Europeo di Oncologia — Milan, Italy (Completed)
- Azienda Ospedaliera Universitaria Federico II — Naples, Italy (Completed)
- Casa di Cura La Maddalena — Palermo, Italy (Completed)
- Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli' — Roma, Italy (Completed)
- Presidio Ospedaliero Santo Spirito in Sassia — Roma, Italy (Completed)
- Ospedale Andrea Tortora Pagani Salerno — Salerno, Italy (Completed)
- Ospedale Ca' Foncello — Treviso, Italy (Completed)
- Azienda Sanitaria Universitaria Giuliano Isontina Ospedale Maggiore — Trieste, Italy (Completed)
- Ospedale Castelli — Verbania, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.