Clinical trial NCT06285318: A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials
Official title: A Retrospective, Multicountry Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma Treated With T-cell Redirectors Outside of Clinical Trials
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Relapsed/Refractory Multiple Myeloma (RRMM)
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-29
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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 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

Primary outcomes:
measure: Describe Baseline Characteristics of Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who Received Teclistamab/ Talquetamab Outside of Clinical Trials
timeFrame: Baseline (Day 1)
measure: Overall Response Rate (ORR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
timeFrame: Up to 40 months
measure: Time to First Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
timeFrame: Up to 40 months
measure: Time to Best Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
timeFrame: Up to 40 months
measure: Duration of Response (DOR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
timeFrame: Up to 40 months
measure: Minimal Residue Assessment (MRD) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
timeFrame: Up to 40 months
measure: Overall Survival (OS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
timeFrame: From the date of first dose of teclistamab/talquetamab to the date of the participant's death (up to 40 months)
measure: Progression Free Survival (PFS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
timeFrame: Up to 40 months
measure: Time to Next Treatment (TTNT) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
timeFrame: Up to 40 months
measure: Describe the Safety Management of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials
timeFrame: Baseline (Day 1) up to end of treatment (up to 40 months)
Secondary outcomes:
measure: Describe the Use of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials
timeFrame: Baseline (Day 1) up to end of treatment (up to 40 months)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
city: Vejle
country: Denmark
facility: Sygehus Lillebælt, Vejle
city: Lille cedex
country: France
facility: Hopital Albert Calmette - CHU Lille
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Nantes
country: France
facility: CHU de Nantes hotel Dieu
city: Paris
country: France
facility: Hopital Saint Louis
city: Toulouse Cedex 9
country: France
facility: Institut Universitaire du Cancer Toulouse Oncopole
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU de Nancy - Hopitaux de Brabois
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus Dresden
city: Hamburg
country: Germany
facility: University Hospital Hamburg Eppendorf
city: Heidelberg
country: Germany
facility: Uniklinikum Heidelberg
city: Nuernberg
country: Germany
facility: Klinikum Nurnberg Nord
city: Wurzburg
country: Germany
facility: Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii
city: Cork N/a
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: St James Hospital
city: Galway
country: Ireland
facility: University Hospital Galway - Ireland
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola Malpighi
city: Brindisi
country: Italy
facility: Ospedale A.Perrino di Brindisi
city: Firenze
country: Italy
facility: AOU Careggi
city: Milano
country: Italy
facility: Policlinico di Milano
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Palermo
country: Italy
facility: Casa di Cura La Maddalena
city: Roma
country: Italy
facility: Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'
city: Roma
country: Italy
facility: Presidio Ospedaliero Santo Spirito in Sassia
city: Madrid
country: Spain
facility: Hosp. Univ. de La Paz
city: Malaga
country: Spain
facility: Hosp. Costa Del Sol
city: Vigo
country: Spain
facility: Hosp. Alvaro Cunqueiro
city: Goteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Jonkoping
country: Sweden
facility: Länssjukhuset Ryhov
city: Stockholms
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Uddevalla
country: Sweden
facility: Uddevalla Hospital
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: London
country: United Kingdom
facility: University College Hospital
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton Hospitals NHS Trust - New Cross Hosp
Study officials:
affiliation: Janssen-Cilag Limited
name: Janssen-Cilag Limited Clinical Trial
role: STUDY_DIRECTOR
References: