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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJanssen-Cilag Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Study population include patients who have initiated the treatment with T-cell redirectors outside of a clinical trial setting.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Teclistamab

    Other intervention

    No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.

  • Talquetamab

    Other intervention

    No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.

Treatment groups

900 Participants
are divided into 4 treatment groups
Group A: Participants with Relapsed/Refractory Multiple Myeloma (RRMM): Teclistamab Cohort 11 intervention
Group B: Participants with Relapsed/Refractory Multiple Myeloma (RRMM): Teclistamab Cohort 21 intervention
Group C: Participants with RRMM: Teclistamab Cohort 31 intervention
Group D: Participants with RRMM: Talquetamab Cohort1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (Day 1)
2

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.

Time frame
Up to 40 months
3

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.

Time frame
Up to 40 months
4

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.

Time frame
Up to 40 months

Secondary outcomes

1

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.

Time frame
Baseline (Day 1) up to end of treatment (up to 40 months)

Other outcomes

Sponsors and contacts

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