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| Name | Class |
|---|---|
| Janssen Pharmaceutica | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 treatment ≤14 days before intended screening visit |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teclistamab | Drug | Intervention is part of standard clinical care, as Tecvayli/Teclistamab is reimbursed for this group of patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline, monthly until end of study (maximum 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline, monthly until end of study (maximum 24 months) |
| Overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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100 patients with relapsed or refractory multiple myelome who will be treated with teclistamab (Tecvayli®)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michel Delforge, MD, PhD | Contact | +32 16 34 68 80 | michel.delforge@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Michel Delforge, MD, PhD | UZ Leuven Gasthuisberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imelda | Not yet recruiting | Bonheiden | Antwerpen | 2820 | Belgium |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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Duration of time between start of the treatment and up to the time of death.
| 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 (Tecvayli®). | 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. | 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. | 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. | 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). | 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. | At baseline, monthly until end of study (maximum 24 months) |
| Universitair Ziekenhuis Antwerpen (UZA) | Recruiting | Edegem | Antwerpen | 2500 | Belgium |
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| Grand Hôpital de Charleroi | Recruiting | Charleroi | Henegouwen | 6000 | Belgium |
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| EpiCURA | Recruiting | Hornu | Henegouwen | 7301 | Belgium |
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| CHU Ambroise Paré | Recruiting | Mons | Henegouwen | 7000 | Belgium |
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| Jessa Ziekenhuis | Recruiting | Hasselt | Limburg | 3500 | Belgium |
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| CHR Citadelle | Recruiting | Liège | Liège | 4000 | Belgium |
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| CHU Liège | Recruiting | Liège | Liège | 4000 | Belgium |
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| CHU UCL Namur | Recruiting | Yvoir | Namur | 5530 | Belgium |
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| Algemeen Ziekenhuis Maria Middelares (AZMM) | Recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
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| Universitair Ziekenhuis Gent (UZ Gent) | Recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
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| Vitaz | Recruiting | Sint-Niklaas | Oost-Vlaanderen | 9100 | Belgium |
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| Institut Jules Bordet | Recruiting | Brussels | Vlaams-Brabant | 1070 | Belgium |
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| UCL Saint Luc | Recruiting | Brussels | Vlaams-Brabant | 1200 | Belgium |
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| AZ Groeninge | Recruiting | Kortrijk | West-Vlaanderen | 8500 | Belgium |
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| AZ Delta | Recruiting | Roeselare | West-Vlaanderen | 8800 | Belgium |
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| UZ Leuven Gasthuisberg | Recruiting | Leuven | 3000 | Belgium |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |