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

May 7, 2026 updated by: Janssen-Cilag Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Aalborg, Denmark, 9100
        • Recruiting
        • Aalborg Sygehus Syd
      • Aarhus N, Denmark, 8200
        • Completed
        • Aarhus Universitetshospital
      • Copenhagen, Denmark, 2100
        • Completed
        • Rigshospitalet
      • Odense, Denmark, 5000
        • Completed
        • Odense University Hospital
      • Vejle, Denmark, 7100
        • Recruiting
        • Sygehus Lillebælt, Vejle
  • France
      • Lille, France, 59037
        • Recruiting
        • Hopital Albert Calmette - CHU Lille
      • Marseille, France, 13009
        • Completed
        • Institut Paoli Calmettes
      • Nantes, France, 44000
        • Recruiting
        • CHU de Nantes hotel Dieu
      • Paris, France, 75475
        • Completed
        • Hopital Saint Louis
      • Toulouse, France, 31100
        • Recruiting
        • Institut Universitaire du Cancer Toulouse Oncopole
      • Vandœuvre-lès-Nancy, France, 54500
        • Completed
        • CHRU de Nancy - Hôpitaux de Brabois
  • Germany
      • Chemnitz, Germany, 09116
        • Completed
        • Klinikum Chemnitz gGmbH
      • Dresden, Germany, 01307
        • Completed
        • Universitätsklinikum Carl Gustav Carus Dresden
      • Hamburg, Germany, 20246
        • Recruiting
        • University Hospital Hamburg Eppendorf
      • Hanover, Germany, 30459
        • Recruiting
        • Klinikum Region Hannover Klinikum Siloah
      • Heidelberg, Germany, 69120
        • Completed
        • Uniklinikum Heidelberg 1
      • Nuremberg, Germany, 90419
        • Completed
        • Klinikum Nürnberg Nord
      • Würzburg, Germany, 97080
        • Recruiting
        • Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii
  • Greece
      • Alexandroupoli, Greece, 68100
        • Recruiting
        • University Hospital of Alexandroupolis
      • Athens, Greece, 115 28
        • Recruiting
        • Alexandra Hospital
      • Athens, Greece, 115 27
        • Recruiting
        • Laiko General Hospital of Athens
      • Heraklion, Greece, 715 00
        • Completed
        • University Hospital of Crete, PAGNI
      • Ioannina, Greece, 45500
        • Recruiting
        • Ioannina University Hospital
      • Larissa, Greece, 413 34
        • Recruiting
        • University Hospital of Larissa
      • Thessaloniki, Greece, 54636
        • Recruiting
        • AHEPA University General Hospital of Thessaloniki
      • Thessaloniki, Greece, 546 39
        • Recruiting
        • Anticancer Hospital of Thessaloniki Theageneio
      • Thessaloniki, Greece, 570 10
        • Recruiting
        • G Papanikolaou Hospital of Thessaloniki
  • Ireland
      • Cork, Ireland, 00000
        • Completed
        • Cork University Hospital
      • Cork, Ireland, T12 DV56
        • Completed
        • Bon Secours Hospital
      • Dublin, Ireland, D08 NHY1
        • Completed
        • St James Hospital
      • Dublin, Ireland, D18 AK68
        • Completed
        • Beacon Hospital
      • Galway, Ireland, H91 YR71
        • Completed
        • University Hospital Galway - Ireland
  • Israel
      • Jerusalem, Israel, 9112001
        • Completed
        • Hadassah Medical Center
      • Ramat Gan, Israel, 52621
        • Completed
        • Sheba Medical Center
      • Tel Aviv, Israel, 6423906
        • Completed
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Bologna, Italy, 40138
        • Completed
        • Policlinico Sant'Orsola Malpighi
      • Bolzano, Italy, 39100
        • Completed
        • Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano
      • Brindisi, Italy, 72100
        • Completed
        • Ospedale A.Perrino di Brindisi
      • Florence, Italy, 50141
        • Completed
        • AOU Careggi
      • Lecce, Italy, 73100
        • Completed
        • Ospedale Vito Fazzi
      • Milan, Italy, 20121
        • Completed
        • Policlinico di Milano
      • Milan, Italy, 20252
        • Completed
        • IRCCS Istituto Europeo di Oncologia
      • Naples, Italy, 80131
        • Completed
        • Azienda Ospedaliera Universitaria Federico II
      • Palermo, Italy, 90146
        • Completed
        • Casa di Cura La Maddalena
      • Roma, Italy, 65124
        • Completed
        • Presidio Ospedaliero Santo Spirito in Sassia
      • Roma, Italy, 00168
        • Completed
        • Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'
      • Salerno, Italy, 84098
        • Completed
        • Ospedale Andrea Tortora Pagani Salerno
      • Treviso, Italy, 31100
        • Completed
        • Ospedale Ca' Foncello
      • Trieste, Italy, 34128
        • Completed
        • Azienda Sanitaria Universitaria Giuliano Isontina Ospedale Maggiore
      • Verbania, Italy, 28922
        • Completed
        • Ospedale Castelli
      • Vicenza, Italy, 36100
        • Completed
        • Ospedale San Bortolo
  • Norway
      • Oslo, Norway, 1478
        • Recruiting
        • Akershus Universitetssykehus
      • Tønsberg, Norway, 3103
        • Recruiting
        • Vestfold Hospital Trust
  • Spain
      • Granada, Spain, 18014
        • Recruiting
        • Hosp. Univ. Virgen de Las Nieves
      • Madrid, Spain, 28006
        • Recruiting
        • Hosp. Univ. de La Princesa
      • Madrid, Spain, 28046
        • Recruiting
        • Hosp. Univ. de La Paz
      • Málaga, Spain, 29603
        • Completed
        • Hosp. Costa Del Sol
      • Valencia, Spain, 46010
        • Recruiting
        • Hosp. Clinico Univ. de Valencia
      • Vigo, Spain, 36213
        • Recruiting
        • Hosp. Alvaro Cunqueiro
      • Ávila, Spain, 05071
        • Recruiting
        • Hosp. Ntra. Sra. de Sonsoles
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Recruiting
        • Sahlgrenska University Hospital
      • Jönköping, Sweden, 551 85
        • Completed
        • Länssjukhuset Ryhov
      • Stockholms, Sweden, 12559
        • Recruiting
        • Karolinska Universitetssjukhuset
      • Uddevalla, Sweden, 451 98
        • Completed
        • Uddevalla Hospital
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • Recruiting
        • Queen Elizabeth Hospital
      • London, United Kingdom, NW1 2PG
        • Recruiting
        • University College Hospital
      • London, United Kingdom, SE1 9RT
        • Completed
        • Guys and St Thomas NHS Foundation Trust
      • Wolverhampton, United Kingdom, WV10 0QP
        • Recruiting
        • The Royal Wolverhampton Hospitals NHS Trust - New Cross Hosp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study population include patients who have initiated the treatment with T-cell redirectors outside of a clinical trial setting.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: 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 Names:
  • TALVEY
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.
Other: 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.
Other Names:
  • TECVAYLI
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.
Other: 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.
Other Names:
  • TECVAYLI
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.
Other: 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.
Other Names:
  • TECVAYLI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe Baseline Characteristics of Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who Received Teclistamab/ Talquetamab Outside of Clinical Trials
Time Frame: Baseline (Day 1)
Participants' demographics and disease characteristics (age, co-morbidities, renal function), and prior antimyeloma therapies will be reported.
Baseline (Day 1)
Overall Response Rate (ORR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
Time Frame: Up to 40 months
ORR is defined as the percentage of patients who have a PR or better as assessed by investigator per International Myeloma Working Group (IMWG) response criteria.
Up to 40 months
Time to First Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
Time Frame: Up to 40 months
Time to first response is defined as the time between date of first dose of teclistamab/talquetamab and the date when patient has achieved first response, as assessed by investigator per IMWG response criteria.
Up to 40 months
Time to Best Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
Time Frame: Up to 40 months
Time to best response is defined as the time between date of first dose of teclistamab/talquetamab and the date of the best response, as assessed by investigator per IMWG response criteria.
Up to 40 months
Duration of Response (DOR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
Time Frame: Up to 40 months
DOR will be calculated among participants (with a PR or better response) from the date of the first response (PR or better) to the date of first evidence of progressive disease, as assessed by investigator per IMWG response criteria.
Up to 40 months
Minimal Residue Assessment (MRD) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
Time Frame: Up to 40 months
Number of participants with MRD negative rate will be assessed.
Up to 40 months
Overall Survival (OS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
Time Frame: From the date of first dose of teclistamab/talquetamab to the date of the participant's death (up to 40 months)
OS is defined as the time from the date of first dose of teclistamab/talquetamab to the date of the participant's death.
From the date of first dose of teclistamab/talquetamab to the date of the participant's death (up to 40 months)
Progression Free Survival (PFS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
Time Frame: Up to 40 months
PFS is defined as the time from the date of first dose of teclistamab/talquetamab to the date of first evidence of progressive disease, as assessed by investigator per IMWG response criteria, or death due to any cause, whichever occurs first.
Up to 40 months
Time to Next Treatment (TTNT) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
Time Frame: Up to 40 months
TTNT is defined as the time from the date of first dose of teclistamab/talquetamab to the start of the next line of antimyeloma treatment.
Up to 40 months
Describe the Safety Management of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials
Time Frame: Baseline (Day 1) up to end of treatment (up to 40 months)
Incidence and severity of adverse events (AEs) including immune effector cell-associated neurotoxicity syndrome (ICANS), cytokine release syndrome (CRS) and other AEs as well as medications used for prophylaxis and management of adverse events will be reported.
Baseline (Day 1) up to end of treatment (up to 40 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the Use of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials
Time Frame: Baseline (Day 1) up to end of treatment (up to 40 months)
Treatment patterns including healthcare setting and treatment schedules will be reported.
Baseline (Day 1) up to end of treatment (up to 40 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag Ltd.

Investigators

  • Study Director: Janssen-Cilag Limited Clinical Trial, Janssen-Cilag Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 24, 2026

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 64007957MMY4004 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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