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

Relapsed/Refractory Multiple Myeloma (RRMM) Clinical Trial

— REALiTEC/TAL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06285318
• Other study ID #: 64007957MMY4004
• Status: Recruiting
• Start date: December 18, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: June 2024
• Source: Janssen-Cilag Ltd.
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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) 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 cohort 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed/Refractory Multiple Myeloma (RRMM)

Intervention

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 Case Report Form (CRF).
• 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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Denmark	Odense University Hospital	Odense
Denmark	Sygehus Lillebælt, Vejle	Vejle
France	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
Germany	Universitäres Herzzentrum Hamburg	Hamburg
Germany	Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii	Wurzburg
Israel	Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv Yafo
Italy	Policlinico Sant'Orsola Malpighi	Bologna
Italy	Policlinico di Milano	Milano
Italy	Presidio Ospedaliero Santo Spirito in Sassia	Roma
Spain	Hosp. Univ. de La Paz	Madrid
Spain	Hosp. Costa Del Sol	Malaga
Sweden	Sahlgrenska University Hospital	Goteborg
Sweden	Länssjukhuset Ryhov	Jonkoping
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	University College Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag Ltd.

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Israel,  Italy,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe Baseline Characteristics of Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who Received Teclistamab/ Talquetamab Outside of Clinical Trials	Participants' demographics and disease characteristics (age, co-morbidities, renal function), and prior antimyeloma therapies will be reported.	Baseline (Day 1)
Primary	Overall Response Rate (ORR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials	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.	Up to 40 months
Primary	Time to First Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials	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.	Up to 40 months
Primary	Time to Best Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials	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.	Up to 40 months
Primary	Duration of Response (DOR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials	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.	Up to 40 months
Primary	Minimal Residue Assessment (MRD) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials	Number of participants with MRD negative rate will be assessed.	Up to 40 months
Primary	Overall Survival (OS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials	OS is defined as the time from the date of first dose of teclistamab/talquetamab to the date of the participant's death.	From the date of first dose of teclistamab/talquetamab to the date of the participant's death (up to 40 months)
Primary	Progression Free Survival (PFS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials	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.	Up to 40 months
Primary	Time to Next Treatment (TTNT) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials	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.	Up to 40 months
Primary	Describe the Safety Management of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials	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.	Baseline (Day 1) up to end of treatment (up to 40 months)
Secondary	Describe the Use of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials	Treatment patterns including healthcare setting and treatment schedules will be reported.	Baseline (Day 1) up to end of treatment (up to 40 months)