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

Official title

64007957MMY4004: 64007957MMY4004 - REALiTEC

Overview

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

Interventions

• 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 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.

Primary outcome measures

• Describe Baseline Characteristics of Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who Received Teclistamab/ Talquetamab Outside of Clinical Trials [Time frame: 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]
• Time to First Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials [Time frame: 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]
• Duration of Response (DOR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials [Time frame: 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]
• 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)]
• Progression Free Survival (PFS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials [Time frame: 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]
• 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)]

Secondary outcome measures (1)

• 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)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 16 centers

• Policlinico Sant'Orsola Malpighi — Bologna
• Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano — Bolzano
• Ospedale A.Perrino di Brindisi — Brindisi
• AOU Careggi — Florence
• Ospedale Vito Fazzi — Lecce
• Policlinico di Milano — Milan
• IRCCS Istituto Europeo di Oncologia — Milan
• Azienda Ospedaliera Universitaria Federico II — Naples
• … and 8 more centers

Greece · 9 centers

• University Hospital of Alexandroupolis — Alexandroupoli
• Laiko General Hospital of Athens — Athens
• Alexandra Hospital — Athens
• University Hospital of Crete, PAGNI — Heraklion
• Ioannina University Hospital — Ioannina
• University Hospital Of Larissa — Larissa
• Anticancer Hospital of Thessaloniki Theageneio — Thessaloniki
• Ahepa University General Hospital of Thessaloniki — Thessaloniki
• … and 1 more center

Germany · 7 centers

• Klinikum Chemnitz gGmbH — Chemnitz
• Universitatsklinikum Carl Gustav Carus Dresden — Dresden
• University Hospital Hamburg Eppendorf — Hamburg
• Klinikum Region Hannover Klinikum Siloah — Hanover
• Uniklinikum Heidelberg 1 — Heidelberg
• Klinikum Nurnberg Nord — Nuremberg
• Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii — Würzburg

Spain · 7 centers

• Hosp. Ntra. Sra. de Sonsoles — Ávila
• Hosp. Univ. Virgen de Las Nieves — Granada
• Hosp. Univ. de La Princesa — Madrid
• Hosp. Univ. de La Paz — Madrid
• Hosp. Costa Del Sol — Málaga
• Hosp. Clinico Univ. de Valencia — Valencia
• Hosp. Alvaro Cunqueiro — Vigo

France · 6 centers

• Hopital Albert Calmette - CHU Lille — Lille
• Institut Paoli Calmettes — Marseille
• CHU de Nantes hotel Dieu — Nantes
• Hopital Saint Louis — Paris
• Institut Universitaire du Cancer Toulouse Oncopole — Toulouse
• CHRU de Nancy - Hopitaux de Brabois — Vandœuvre-lès-Nancy

Denmark · 5 centers

• Aalborg Sygehus Syd — Aalborg
• Aarhus Universitetshospital — Aarhus N
• Rigshospitalet — Copenhagen
• Odense University Hospital — Odense
• Sygehus Lillebælt, Vejle — Vejle

Ireland · 5 centers

• Cork University Hospital — Cork
• Bon Secours Hospital — Cork
• St James Hospital — Dublin
• Beacon Hospital — Dublin
• University Hospital Galway - Ireland — Galway

Sweden · 4 centers

• Sahlgrenska University Hospital — Gothenburg
• Länssjukhuset Ryhov — Jönköping
• Karolinska Universitetssjukhuset — Stockholms
• Uddevalla Hospital — Uddevalla

United Kingdom · 4 centers

• Queen Elizabeth Hospital — Birmingham
• University College Hospital — London
• Guys and St Thomas NHS Foundation Trust — London
• The Royal Wolverhampton Hospitals NHS Trust - New Cross Hosp — Wolverhampton

Israel · 3 centers

• Hadassah Medical Center — Jerusalem
• Sheba Medical Center — Ramat Gan
• Tel Aviv Sourasky Medical Center — Tel Aviv

Norway · 2 centers

• Akershus Universitetssykehus — Oslo
• Vestfold Hospital Trust — Tønsberg

Identifiers

NCT: NCT06285318 · 64007957MMY4004 · 64007957MMY4004

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗