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

Recruiting

• Conditions: Relapsed/Refractory Multiple Myeloma (RRMM)
• Interventions: Other: Teclistamab; Other: Talquetamab

• Registration Number: NCT06285318
• Lead Sponsor: Janssen-Cilag Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-27
• Study Start: 2023-12-18
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-06-30
• Study Completion: 2026-10-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with Relapsed/Refractory Multiple Myeloma (RRMM): Teclistamab Cohort	Teclistamab	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.
Participants with RRMM: Talquetamab Cohort	Talquetamab	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.

Primary Outcome Measures

Name	Time	Method
Time to First Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials	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.
Time to Next Treatment (TTNT) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials	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.
Describe the Safety Management of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials	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.
Overall Response Rate (ORR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials	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.
Progression Free Survival (PFS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials	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.
Time to Best Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials	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.
Describe Baseline Characteristics of Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who Received Teclistamab/ Talquetamab Outside of Clinical Trials	Baseline (Day 1)	Participants' demographics and disease characteristics (age, co-morbidities, renal function), and prior antimyeloma therapies will be reported.
Duration of Response (DOR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials	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.
Minimal Residue Assessment (MRD) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials	Up to 40 months	Number of participants with MRD negative rate will be assessed.
Overall Survival (OS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials	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.

Secondary Outcome Measures

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

Trial Locations

Locations (40)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Sygehus Lillebælt, Vejle; 🇩🇰 Vejle, Denmark

Hopital Albert Calmette - CHU Lille; 🇫🇷 Lille cedex, 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 Cedex 9, 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

Uniklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Klinikum Nurnberg Nord; 🇩🇪 Nuernberg, Germany

Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii; 🇩🇪 Wurzburg, Germany

Cork University Hospital; 🇮🇪 Cork N/a, Ireland

St James Hospital; 🇮🇪 Dublin, Ireland

University Hospital Galway - Ireland; 🇮🇪 Galway, Ireland

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv Yafo, Israel

Policlinico Sant'Orsola Malpighi; 🇮🇹 Bologna, Italy

Ospedale A.Perrino di Brindisi; 🇮🇹 Brindisi, Italy

AOU Careggi; 🇮🇹 Firenze, Italy

Policlinico di Milano; 🇮🇹 Milano, 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

Hosp. Univ. de La Paz; 🇪🇸 Madrid, Spain

Hosp. Costa Del Sol; 🇪🇸 Malaga, Spain

Hosp. Alvaro Cunqueiro; 🇪🇸 Vigo, Spain

Sahlgrenska University Hospital; 🇸🇪 Goteborg, Sweden

Länssjukhuset Ryhov; 🇸🇪 Jonkoping, 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