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Recruiting NCT06477783

Study on the Clinical Efficacy of Teclistamab

— Observational Multiple Myeloma Hematologic Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Teclistamab.
Who it may be relevant to
Registry conditions: Multiple Myeloma, Hematologic Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Overall response rate [Time frame: At baseline, monthly until end of study (maximum 24 months)]
Secondary outcome measures (8)
  • Progression-free survival (PFS) [Time frame: At baseline, monthly until end of study (maximum 24 months)]
  • Overall survival (OS) [Time frame: At baseline, monthly until end of study (maximum 24 months)]
  • Incidence of (serious) adverse events [Time frame: At baseline, monthly until end of study (maximum 24 months)]
  • Depth of response [Time frame: At baseline, monthly until end of study (maximum 24 months)]
  • Time to response (TTR) [Time frame: At baseline, monthly until end of study (maximum 24 months)]
  • Duration of response [Time frame: At baseline, monthly until end of study (maximum 24 months)]
  • Minimal Residual Disease (MRD) assessment [Time frame: At suspected CR, every 6 months thereafter until end of study (maximum 24 months)]
  • Time to next treatment (TTNT) [Time frame: At baseline, monthly until end of study (maximum 24 months)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 17 centers
  • Imelda — Bonheiden
  • Universitair Ziekenhuis Antwerpen (UZA) — Edegem
  • Grand Hôpital de Charleroi — Charleroi
  • EpiCURA — Hornu
  • CHU Ambroise Paré — Mons
  • Jessa Ziekenhuis — Hasselt
  • CHR Citadelle — Liège
  • CHU Liège — Liège
  • … and 9 more centers

Identifiers

NCT: NCT06477783 · 64007957MMY4010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗