Recruiting NCT05945524
Analysis of the Resistance and Sensitivity Mechanisms to Teclistamab by Focusing on Single Immune Cell Examination
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: Bone marrow sampling.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. 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
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The aim of this study is to discover the immune and oncogenomic features that distinguish patients who respond to teclistamab from patients who are primarily resistant. Moreover, phenotypic and genotypic characteristics that occur with secondary resistance to teclistamab will be analyzed.
Interventions
- Other Bone marrow sampling
Bone marrow sampling collected at 12 weeks after initiation treatment (day 1 cycle 4)
Primary outcome measures
- Response to teclistamab at 12 weeks [Time frame: at day 1 Cycle 4 (each cycle is 28 days)]
Eligibility criteria
Inclusion criteria
- With multiple myeloma
- Who receive Teclistamab
- Consent form signed
Exclusion criteria
- Patient under legal protection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 18 centers
- CHU d'Amiens — Amiens
- CHU de Caen — Caen
- Polyclinique du Parc Drevon — Dijon
- CH Annecy Genevois — Epagny Metz- Tessy
- CHU de Lille — Lille
- Centre Léon Bérard — Lyon
- CHU de Montpellier — Montpellier
- Hôpital Saint-Louis — Paris
- … and 10 more centers
Identifiers
NCT: NCT05945524 · RC31/23/0278