Multiple MyelomaResisTecNCT05945524
Analysis of the Resistance and Sensitivity Mechanisms to Teclistamab by Focusing on Single Immune Cell Examination
A study testing Bone marrow sampling in people with Multiple Myeloma, run by University Hospital, Toulouse at 18 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Bone marrow sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 18 sitesFrance
- Study dates
- 28 Sep 2023to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With multiple myeloma
- Who receive Teclistamab
- Consent form signed
Who cannot join
- Patient under legal protection
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
France18 sites, 18 recruiting
- Recruiting
CHU d'Amiens
Amiens, France, 80054
Lydia MONTES, MD, 0222455482 ext. 33, montes.lydia@chu-amiens.fr
- Recruiting
CHU de Caen
Caen, France, 14033
Margaret MACRO, MD, PhD, 0231272633 ext. 33, macro-m@chu-caen.fr
- Recruiting
Polyclinique du Parc Drevon
Dijon, France, 21000
Ingrid LAFON, MD, 0380294506 ext. 33, ilafon@icb-cancer.fr
- Recruiting
CH Annecy Genevois
Epagny Metz- Tessy, France, 74370
Frédérique ORSINI PIOCELLE, MD, 0450636144 ext. 33, forsinipiocelle@ch-annecygenevois.fr
- Recruiting
CHU de Lille
Lille, France, 59037
Salomon MANIER, MD, 0320444292 ext. 33, salomon.manier@chru-lille.fr
- Recruiting
Centre Léon Bérard
Lyon, France, 69373
Philippe REY, MD, 0478782737 ext. 33, philippe.rey@lyon.unicancer.fr
- Recruiting
CHU de Montpellier
Montpellier, France, 34295
Laure VINCENT, MD, 0467338362 ext. 33, l-vincent@chu-montpellier.fr
- Recruiting
Hôpital Saint-Louis
Paris, France, 75010
Bertrand ARNULF, MD, PhD, 0142499695 ext. 33, bertrand.arnulf@sls.aphp.fr
- Recruiting
Hôpital Saint-Antoine
Paris, France, 75012
Mohamad MOTHY, MD, 0149282620 ext. 33, mohamad.mohty@inserm.fr
- Recruiting
Hôpital Necker
Paris, France, 75015
Laurent FRENZEL, MD, 0144495292 ext. 33, laurent.frenzel@aphp.fr
- Recruiting
CHU de Bordeaux
Pessac, France, 33600
Cyrille HULIN, MD, 0557623372 ext. 33, cyrille.hulin@chu-bordeaux.fr
- Recruiting
CHU de Lyon
Pierre-Bénite, France, 69495
Lionel KARLIN, MD, 0448864309 ext. 33, lionel.karlin@chu-lyon.fr
- Recruiting
CHU de Poitiers
Poitiers, France, 86021
Xavier LELEU, MD, PhD, 0549444201 ext. 33, xavier.leleu@chu-poitiers.fr
- Recruiting
CHU de Rennes
Rennes, France, 35033
Olivier DECAUX, MD, PhD, 0299287692 ext. 33, olivier.decaux@chu-rennes.fr
- Recruiting
CH Saint-Etienne
Saint-Priest-en-Jarez, France, 42271
Emilie CHALAYER, MD, 0477917061 ext. 33, emilie.chalayer@chu-st-etienne.fr
- Recruiting
CHU de Toulouse
Toulouse, France, 31059
Aurore PERROT, MD, PhD, 0531156490 ext. 33, perrot.aurore@iuct-oncopole.fr
- Recruiting
CHU de Tours
Tours, France, 37044
Thomas CHALOPIN, MD, 0247473712 ext. 33, t.chalopin@chu-tours.fr
- Recruiting
CHRU Nancy
Vandœuvre-lès-Nancy, France, 54500
Caroline JACQUET, MD, 0383155249 ext. 33, c.jacquet@chru-nancy.fr
About this study
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.
- Conditions
- Multiple Myeloma
- Being tested
- Bone marrow sampling
- Keywords
- Teclistamab, Resistance, Immune Cell
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow samplingOther
Bone marrow sampling collected at 12 weeks after initiation treatment (day 1 cycle 4)
| Study group | Role | What they receive |
|---|---|---|
| Analysis of bone marrow | Experimental | Analysis of bone marrow in patients initiated treatment by Teclistamab for 18 cycles Receives: Other: Bone marrow sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to teclistamab at 12 weeks
response according to International Myeloma Working Group criteria
Measured: at day 1 Cycle 4 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start28 Sep 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé AVET LOISEAU, MD, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945524
- Sponsor's protocol ID
- RC31/23/0278
- Acronym
- ResisTec
- Status last verified
- Apr 2025
- First submitted
- 16 May 2023
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Resistance and Sensitivity Mechanisms to Teclistamab by Focusing on Single Immune Cell Examination
- ClinicalTrials.gov ID
- NCT05945524
- Acronym / sponsor ID
- ResisTec / RC31/23/0278
- Conditions
- Multiple Myeloma
- Keywords
- Teclistamab, Resistance, Immune Cell
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Analysis of bone marrow | Experimental | Other: Bone marrow samplingAnalysis of bone marrow in patients initiated treatment by Teclistamab for 18 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- With multiple myeloma
- Who receive Teclistamab
- Consent form signed
Key exclusion criteria (1 listed)
- Patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone marrow samplingBone marrow sampling collected at 12 weeks after initiation treatment (day 1 cycle 4) | Other | Analysis of bone marrow |
Primary outcome
Response to teclistamab at 12 weeks
Time frame: at day 1 Cycle 4 (each cycle is 28 days)
response according to International Myeloma Working Group criteria
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
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A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Active, not recruitingPhase 1/2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hervé AVET LOISEAU, MD, PhD principal investigator
University Hospital, Toulouse
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone marrow sampling in people with Multiple Myeloma, run by University Hospital, Toulouse at 18 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hervé AVET LOISEAU, MD, PhD (+33 531 156 142 ext. 33, avetloiseau.herve@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to teclistamab at 12 weeks (time frame: at day 1 Cycle 4 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.