Multiple MyelomaBIONICNCT06477783
Study on the Clinical Efficacy of Teclistamab and Talquetamab
An observational study of Multiple Myeloma and Hematologic Diseases, run by Universitaire Ziekenhuizen KU Leuven at 17 sites in Belgium.
Trial summary
The aim of this study is to assess the clinical efficacy of the anti-BCMA/CD3 bispecific antibody teclistamab and anti-GPRC5D/CD3 bispecific antibody talquetamab in a prospective, real-life setting in Belgium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Hematologic Diseases
- What is being tested?
- Teclistamab
- How many people
- 100 participants
- Where
- 17 sitesBelgium
- Study dates
- 1 Dec 2024to Sep 2027
- Phase
- Observational
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
Study population: 100 patients with relapsed or refractory multiple myelome who will be treated with teclistamab or talquetamab
Who may be able to join
- 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 or talquetamab per routine clinical care or has started with teclistamab treatment ≤28 days before intended screening visit
Who cannot join
- Has started teclistamab or talquetamab treatment >28 days before intended screening visit.
- Inability or unwillingness to comply with the study protocol, including scheduled visits, treatment plans, or follow-up requirements.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
Belgium17 sites, 17 recruiting
- Not yet recruiting
Imelda
Bonheiden, Antwerpen, 2820
Ann Pauwels, +32 15 50 46 25, sec@imelda.be
Helena Maes, MD
- Recruiting
Institut Jules Bordet
Brussels, Vlaams-Brabant, 1070
Bénédicte Vucic, +32 25 41 36 47, benedicte.vucic@hubruxelles.be
Marie Vercruyssen, MD
- Recruiting
UCL Saint Luc
Brussels, Vlaams-Brabant, 1200
Charlene Mouafo, +32 27 64 17 36, charlene.mouafo@saintluc.uclouvain.be
Marie-Christiane Vekemans, MD
- Recruiting
Grand Hôpital de Charleroi
Charleroi, Henegouwen, 6000
Christy Vanderperren, +32 71 10 47 60, christy.VANDERPERREN@ghdc.be
Géraldine Verstraete, MD
- Recruiting
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Antwerpen, 2500
Anouk Smits, +32 38 21 53 98, studies.hematologie@uza.be
Ann Van de Velde, MD, PhD
- Recruiting
Algemeen Ziekenhuis Maria Middelares (AZMM)
Ghent, Oost-Vlaanderen, 9000
Mieke Van Den Berghe, +32 92 46 95 18, Mieke.VanDenBerghe@mijnziekenhuis.be
Veerle Galle, MD
- Recruiting
Universitair Ziekenhuis Gent (UZ Gent)
Ghent, Oost-Vlaanderen, 9000
Studies Hematologie, studies.hematologie@uzgent.be
Nicolas Kint, MD, PhD
- Recruiting
Jessa Ziekenhuis
Hasselt, Limburg, 3500
Elke Van Campenhout, +32 11 33 79 94, elke.vancampenhout@jessazh.be
Koen Theunissen, MD
- Recruiting
EpiCURA
Hornu, Henegouwen, 7301
Sophie Viart, +32 65 61 44 89, sophie.viart@epicura.be
Géraldine Claes, MD
- Recruiting
AZ Groeninge
Kortrijk, West-Vlaanderen, 8500
Ellen Callens, +32 56 63 39 00, ellen.callens@azgroeninge.be
Alexander Salembier, MD
- Recruiting
UZ Leuven Gasthuisberg
Leuven, 3000
Stéphanie Bézy, stephanie.bezy@uzleuven.be
Michel Delforge, MD PhD
- Recruiting
CHR Citadelle
Liège, Liège, 4000
Sophie Ledant, +32 43 21 83 51, sophie.ledant@citadelle.be
Michelle Pirotte, MD
- Recruiting
CHU Liège
Liège, Liège, 4000
Sophie Ledant, +32 43 21 83 51, sophie.ledant@citadelle.be
Michelle Pirotte, MD
- Recruiting
CHU Ambroise Paré
Mons, Henegouwen, 7000
Recherche Clinique, +32 65 41 75 01, recherche.clinique@helora.be
Caroline Jacquy, MD, PhD
- Recruiting
AZ Delta
Roeselare, West-Vlaanderen, 8800
Ruth Demeersseman, +32 51 23 75 60, ruth.demeersseman@azdelta.be
Rutger Callens, MD
- Recruiting
Vitaz
Sint-Niklaas, Oost-Vlaanderen, 9100
Isabel de Brabander, +32 37 60 25 73, isabel.debrabander@vitaz.be
Isabelle Vande Broek, MD, PhD
- Recruiting
CHU UCL Namur
Yvoir, Namur, 5530
Benoit Martin, +32 81 42 38 38, B.martin@chuuclnamur.uclouvain.be
Julien Depaus, MD
About this study
Official title: Prospective Observational Study on the Clinical Efficacy of Teclistamab and Talquetamab in Patients With Relapsed and Refractory Multiple Myeloma in Belgium
The aim of this study is to assess the clinical efficacy of the anti-BCMA/CD3 bispecific antibody teclistamab and anti-GPRC5D/CD3 bispecific antibody talquetamab in a prospective, real-life setting in Belgium.
Read the detailed description
To assess the clinical efficacy and safety of teclistamab and talquetamab in relapsed/refractory multiple myeloma patients who have received at least 3 prior lines of treatment and who will receive teclistamab or talquetamab 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. Then, data will be collected every 3 months until the end of study.
- Conditions
- Multiple Myeloma, Hematologic Diseases
- Being tested
- Teclistamab
- Keywords
- Teclistamab, Tecvayli, Hematology, Efficacy, Safety, Talquetamab, Talvey
- Medical subject headings
- Multiple Myeloma, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeclistamabDrug
Also called Tecvayli
Intervention is part of standard clinical care, as teclistamab and talquetamab are reimbursed for this group of patients.
| Study group | Role | What they receive |
|---|---|---|
| Relapsed or refractory multiple myeloma patients | Patients aged 18 years or older diagnosed with relapsed or refractory multiple myeloma, who received at least 3 prior lines of treatment. They should be refractory to at least 1 proteasome inhibitor, at least 1 immunomodulatory agent, and an anti-CD38 monoclonal antibody. After confirmation of disease progression, the patients will start treatment with teclistamab per routine clinical care or will have started with teclistamab or talquetamab treatment ≤28 days before intended screening visit Receives: Drug: Teclistamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
The primary objective is the overall response rate (partial response (PR) or better) according to the 2016 IMWG response criteria of Multiple myeloma.
Measured: At baseline, monthly until end of study (maximum 24 months)
Secondary outcomes (8)
Progression-free survival (PFS)
The length of time during and after the treatment during which a patient lives with the disease but it does not get worse.
Measured: At baseline, monthly until end of study (maximum 24 months)
Overall survival (OS)
Duration of time between start of the treatment and up to the time of death.
Measured: At baseline, monthly until end of study (maximum 24 months)
Incidence of (serious) adverse events
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/talquetamab.
Measured: At baseline, monthly until end of study (maximum 24 months)
Depth of response
Evaluation of response in terms of depth. Assessment of response according to the 2016 IMWG response criteria of Multiple myeloma.
Measured: At baseline, monthly until end of study (maximum 24 months)
Time to response (TTR)
Assessment of the time it takes for a patient to achieve partial response (PR) or better.
Measured: At baseline, monthly until end of study (maximum 24 months)
Duration of response
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.
Measured: At baseline, monthly until end of study (maximum 24 months)
Minimal Residual Disease (MRD) assessment
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).
Measured: At suspected CR, every 6 months thereafter until end of study (maximum 24 months)
Time to next treatment (TTNT)
Assessment of the time interval between initiation of treatment with Tecvayli® and commencement of the next line of therapy.
Measured: At baseline, monthly until end of study (maximum 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Dec 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (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 Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceutica
- Responsible party
- Sponsor
- Investigators
- Michel Delforge, MD, PhD, Principal investigator, UZ Leuven Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477783
- Sponsor's protocol ID
- 64007957MMY4010
- Acronym
- BIONIC
- Status last verified
- Sep 2026
- First submitted
- 14 May 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No