Hematologic Diseases, Multiple Myeloma
Conditions
Keywords
Teclistamab, Tecvayli, Hematology, Efficacy, Safety
Brief summary
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
DRUGTeclistamab
Intervention is part of standard clinical care, as Tecvayli/Teclistamab is reimbursed for this group of patients.
Sponsors
Janssen Pharmaceutica
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | At baseline, monthly until end of study (maximum 24 months) | The primary objective is the overall response rate (partial response (PR) or better) according to the 2016 IMWG response criteria of Multiple myeloma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | At baseline, monthly until end of study (maximum 24 months) | Duration of time between start of the treatment and up to the time of death. |
| Incidence of (serious) adverse events | At baseline, monthly until end of study (maximum 24 months) | 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®). |
| Depth of response | At baseline, monthly until end of study (maximum 24 months) | Evaluation of response in terms of depth. Assessment of response according to the 2016 IMWG response criteria of Multiple myeloma. |
| Progression-free survival (PFS) | At baseline, monthly until end of study (maximum 24 months) | The length of time during and after the treatment during which a patient lives with the disease but it does not get worse. |
| Duration of response | At baseline, monthly until end of study (maximum 24 months) | 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. |
| Minimal Residual Disease (MRD) assessment | At suspected CR, every 6 months thereafter until end of study (maximum 24 months) | 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). |
| Time to next treatment (TTNT) | At baseline, monthly until end of study (maximum 24 months) | Assessment of the time interval between initiation of treatment with Tecvayli® and commencement of the next line of therapy. |
| Time to response (TTR) | At baseline, monthly until end of study (maximum 24 months) | Assessment of the time it takes for a patient to achieve partial response (PR) or better. |
Countries
Belgium
Contacts
Primary ContactMichel Delforge, MD, PhD
Outcome results
None listed