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

Официальное название

64007957MMY4004: 64007957MMY4004 - REALiTEC

Обзор

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

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Describe Baseline Characteristics of Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who Received Teclistamab/ Talquetamab Outside of Clinical Trials [Срок оценки: Baseline (Day 1)]
• Overall Response Rate (ORR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials [Срок оценки: Up to 40 months]
• Time to First Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials [Срок оценки: Up to 40 months]
• Time to Best Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials [Срок оценки: Up to 40 months]
• Duration of Response (DOR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials [Срок оценки: Up to 40 months]
• Minimal Residue Assessment (MRD) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials [Срок оценки: Up to 40 months]
• Overall Survival (OS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials [Срок оценки: 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 [Срок оценки: Up to 40 months]
• Time to Next Treatment (TTNT) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials [Срок оценки: Up to 40 months]
• Describe the Safety Management of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials [Срок оценки: Baseline (Day 1) up to end of treatment (up to 40 months)]

Вторичные конечные точки (1)

• Describe the Use of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials [Срок оценки: Baseline (Day 1) up to end of treatment (up to 40 months)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 16 центров

• 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
• … и ещё 8 центров

Греция · 9 центров

• 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
• … и ещё 1 центр

Германия · 7 центров

• 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

Испания · 7 центров

• 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

Франция · 6 центров

• 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

Дания · 5 центров

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

Ирландия · 5 центров

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

Швеция · 4 центра

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

Великобритания · 4 центра

• 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

Израиль · 3 центра

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

Норвегия · 2 центра

• Akershus Universitetssykehus — Oslo
• Vestfold Hospital Trust — Tønsberg

Идентификаторы

NCT: NCT06285318 · 64007957MMY4004 · 64007957MMY4004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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