A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials
- Conditions
- Relapsed/Refractory Multiple Myeloma (RRMM)
- Interventions
- Other: TeclistamabOther: 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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
- 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 (36)
Azienda Ospedaliera Universitaria Federico II
🇮🇹Napoli, Italy
Hadassah Medical Center
🇮🇱Jerusalem, Israel
AOU Careggi
🇮🇹Firenze, Italy
Casa di Cura La Maddalena
🇮🇹Palermo, Italy
Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'
🇮🇹Roma, Italy
Uddevalla Hospital
🇸🇪Uddevalla, Sweden
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
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
Universitatsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
University Hospital Hamburg Eppendorf
🇩🇪Hamburg, Germany
Uniklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii
🇩🇪Wurzburg, Germany
Cork University Hospital
🇮🇪Cork N/a, 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
Policlinico di Milano
🇮🇹Milano, Italy
Presidio Ospedaliero Santo Spirito in Sassia
🇮🇹Roma, Italy
Hosp. Univ. de La Paz
🇪🇸Madrid, Spain
Hosp. Costa Del Sol
🇪🇸Malaga, Spain
Sahlgrenska University Hospital
🇸🇪Goteborg, Sweden
Länssjukhuset Ryhov
🇸🇪Jonkoping, Sweden
Karolinska Universitetssjukhuset
🇸🇪Stockholms, Sweden
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
University College Hospital
🇬🇧London, United Kingdom
Guys and St Thomas NHS Foundation Trust
🇬🇧London, United Kingdom
Klinikum Chemnitz gGmbH
🇩🇪Chemnitz, Germany
Klinikum Nurnberg Nord
🇩🇪Nuernberg, Germany
St James Hospital
🇮🇪Dublin, Ireland