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NCT Number: NCT06477783

Study on the Clinical Efficacy of Teclistamab

The aim of this study is to assess the clinical efficacy and safety of the anti-BCMA/CD3 bispecific antibody teclistamab (Tecvayli®) in a prospective, real-life setting in Belgium.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Imelda, Bonheiden, Antwerpen, Belgium

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About this study

To assess the clinical efficacy and safety of teclistamab (Tecvayli®) in relapsed/refractory multiple myeloma patients who have received at least 3 prior lines of treatment and who will receive teclistamab (Tecvayli®) as the next treatment. Patients will be followed up prospectively until the end of study (24 months/2 years), or until disease progression, withdrawal of consent death or loss to follow-up, whichever occurs first. Each patient will have a monthly follow-up from baseline until 6 months of treatment with teclistamab. Then, data will be collected every 3 months until the end of study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years or older
  • Written informed consent
  • Has a diagnosis of relapsed and refractory multiple myeloma
  • Has already received at least three previous treatments
  • Is refractory to at least 1 proteasome inhibitor, at least 1 immunomodulatory agent, and an anti-CD38 monoclonal antibody
  • Evidence of disease progression on the last line of therapy, based on determination of response by the IMWG response criteria
  • Anticipated to start treatment with teclistamab per routine clinical care or has started with teclistamab treatment ≤14 days before intended screening visit

Exclusion criteria

  • Has participated in a teclistamab trial (teclistamab or control arm) or teclistamab Single Patient Request (SPR) program
  • Has started teclistamab treatment >14 days before intended screening visit.

Treatment and study plan

Teclistamab

Drug

Intervention is part of standard clinical care, as Tecvayli/Teclistamab is reimbursed for this group of patients.

Other names: Tecvayli

Primary outcomes

  1. Overall response rate

    Time frame: At baseline, monthly until end of study (maximum 24 months)

    The primary objective is the overall response rate (partial response (PR) or better) according to the 2016 IMWG response criteria of Multiple myeloma.

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: At baseline, monthly until end of study (maximum 24 months)

    The length of time during and after the treatment during which a patient lives with the disease but it does not get worse.

  2. Overall survival (OS)

    Time frame: At baseline, monthly until end of study (maximum 24 months)

    Duration of time between start of the treatment and up to the time of death.

  3. Incidence of (serious) adverse events

    Time frame: At baseline, monthly until end of study (maximum 24 months)

    Incidence and severity of (serious) adverse events with with focus on hematological AE's (≥ grade 3), cytokine release syndrome (CRS) rate, Immune effector cell-associated neurotoxicity syndrome (ICANS) and infections (≥ grade 2) and serious adverse events related to teclistamab (Tecvayli®).

  4. Depth of response

    Time frame: At baseline, monthly until end of study (maximum 24 months)

    Evaluation of response in terms of depth. Assessment of response according to the 2016 IMWG response criteria of Multiple myeloma.

  5. Time to response (TTR)

    Time frame: At baseline, monthly until end of study (maximum 24 months)

    Assessment of the time it takes for a patient to achieve partial response (PR) or better.

  6. Duration of response

    Time frame: At baseline, monthly until end of study (maximum 24 months)

    Assessment of the length of time during which a patient experiences a partial response (PR) or better. It is measure from the start of treatment until disease progression or death.

  7. Minimal Residual Disease (MRD) assessment

    Time frame: At suspected CR, every 6 months thereafter until end of study (maximum 24 months)

    Evaluation of treatment efficacy by monitoring for the presence of a small number of cancer cells that are left in the body. MRD assessment will be done with Next Gen Flow (NGF) or Next Gen Sequencing (NGS).

  8. Time to next treatment (TTNT)

    Time frame: At baseline, monthly until end of study (maximum 24 months)

    Assessment of the time interval between initiation of treatment with Tecvayli® and commencement of the next line of therapy.

Study contacts

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

Michel Delforge, MD, PhD

CONTACT

[email protected]

+32 16 34 68 80

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Janssen Pharmaceutica

Registry information

Official study title

Prospective Observational Study on the Clinical Efficacy of Teclistamab in Patients With Relapsed and Refractory Multiple Myeloma in Belgium

Acronym: TECTONIC

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 27, 2024
Registry last updated
Mar 12, 2025

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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