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Active, not recruiting

NCT Number: NCT06062537

Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients

200 adult patients with multiple myeloma receiving teclistamb will be included. Effectiveness, safety, and condition of use of teclistamab in early access program (post-MA) will be assessed. Primary objective is the evaluation of overall response rate (ORR) of teclistamab according to IMWG criteria.

This is a multicenter, prospective, observational study.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens Picardie, Amiens, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patient (≥18 years) with multiple myeloma who will receive at least one dose of teclistamab (first dose of the step-up dose)

Exclusion criteria

  • Patients alive at the start of the study who did not receive study information or who objected to the collection of data
  • Patients who received teclistamab as part of an interventional clinical trial
  • Patients who are initiating teclistamab as part of a current interventional clinical trial

Treatment and study plan

Primary outcomes

  1. overall response rate (ORR) of teclistamab according to IMWG criteria

    Time frame: 6 months

    ORR is defined as the proportion of subjects who achieve a PR or better according to IMWG criteria.

  2. overall response rate (ORR) of teclistamab according to IMWG criteria

    Time frame: 24 months

    ORR is defined as the proportion of subjects who achieve a PR or better according to IMWG criteria.

Secondary outcomes

  1. Effectiveness of teclistamab

    Time frame: 24 months

    Progression Free Survival 1 and 2 (PFS)

  2. Effectiveness of teclistamab

    Time frame: 24 months

    Overall survival (OS)

  3. Effectiveness of teclistamab

    Time frame: 24 months

    Duration of overall response (DOR)

  4. Effectiveness of teclistamab

    Time frame: 24 months

    Response rate (sCR, CR, VGPR, PR)

  5. Effectiveness of teclistamab

    Time frame: 24 months

    Time to best response

  6. Effectiveness of teclistamab

    Time frame: 24 months

    Time to next treatment (TTNT)

  7. Effectiveness of teclistamab

    Time frame: 24 months

    Time to discontinuation (TTD)

  8. Adverse events of interest

    Time frame: 24 months

    ICANS, CSR and infections

  9. Conditions of use

    Time frame: 1 month

    Patients' profiles (demographics characteristics and medical history)

    • Injection facilities and schedules during step-up dosing phase

  10. Conditions of use

    Time frame: 24 months

    Patients' profiles (demographics characteristics and medical history)

    • Injection facilities and schedules during follow up phase

Sponsors and collaborators

Lead sponsor

Intergroupe Francophone du Myelome

Network

Collaborators

  • Janssen-Cilag Ltd.

Registry information

Official study title

Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients: a Collaborative Janssen - IFM Study IFM 2023-01: TEC-CARE

Acronym: TEC-CARE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2023
Registry last updated
Apr 13, 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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