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NCT Number: NCT06285318

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

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

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teclistamab

Other

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 names: TECVAYLI

Talquetamab

Other

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 names: TALVEY

Primary outcomes

  1. Describe Baseline Characteristics of Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who Received Teclistamab/ Talquetamab Outside of Clinical Trials

    Time frame: Baseline (Day 1)

    Participants' demographics and disease characteristics (age, co-morbidities, renal function), and prior antimyeloma therapies will be reported.

  2. Overall Response Rate (ORR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

    Time frame: Up to 40 months

    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.

  3. Time to First Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

    Time frame: Up to 40 months

    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.

  4. Time to Best Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

    Time frame: Up to 40 months

    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.

  5. Duration of Response (DOR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

    Time frame: Up to 40 months

    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.

  6. Minimal Residue Assessment (MRD) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

    Time frame: Up to 40 months

    Number of participants with MRD negative rate will be assessed.

  7. 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)

    OS is defined as the time from the date of first dose of teclistamab/talquetamab to the date of the participant's death.

  8. Progression Free Survival (PFS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

    Time frame: Up to 40 months

    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.

  9. Time to Next Treatment (TTNT) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

    Time frame: Up to 40 months

    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.

  10. 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)

    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.

Secondary outcomes

  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)

    Treatment patterns including healthcare setting and treatment schedules will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen-Cilag Ltd.

Industry

Registry information

Official study title

64007957MMY4004: 64007957MMY4004 - REALiTEC

Acronym: REALiTEC/TAL

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 29, 2024
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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