Teclistamab
OtherNo Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.
Other names: TECVAYLI
NCT Number: NCT06285318
The purpose of this study is to describe the use of teclistamab/talquetamab in the treatment of patients with RRMM outside of clinical trials.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Aalborg Sygehus Syd, Aalborg, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.
Other names: TECVAYLI
No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.
Other names: TALVEY
Time frame: Baseline (Day 1)
Participants' demographics and disease characteristics (age, co-morbidities, renal function), and prior antimyeloma therapies will be reported.
Time frame: Up to 40 months
ORR is defined as the percentage of patients who have a PR or better as assessed by investigator per International Myeloma Working Group (IMWG) response criteria.
Time frame: Up to 40 months
Time to first response is defined as the time between date of first dose of teclistamab/talquetamab and the date when patient has achieved first response, as assessed by investigator per IMWG response criteria.
Time frame: Up to 40 months
Time to best response is defined as the time between date of first dose of teclistamab/talquetamab and the date of the best response, as assessed by investigator per IMWG response criteria.
Time frame: Up to 40 months
DOR will be calculated among participants (with a PR or better response) from the date of the first response (PR or better) to the date of first evidence of progressive disease, as assessed by investigator per IMWG response criteria.
Time frame: Up to 40 months
Number of participants with MRD negative rate will be assessed.
Time frame: From the date of first dose of teclistamab/talquetamab to the date of the participant's death (up to 40 months)
OS is defined as the time from the date of first dose of teclistamab/talquetamab to the date of the participant's death.
Time frame: Up to 40 months
PFS is defined as the time from the date of first dose of teclistamab/talquetamab to the date of first evidence of progressive disease, as assessed by investigator per IMWG response criteria, or death due to any cause, whichever occurs first.
Time frame: Up to 40 months
TTNT is defined as the time from the date of first dose of teclistamab/talquetamab to the start of the next line of antimyeloma treatment.
Time frame: Baseline (Day 1) up to end of treatment (up to 40 months)
Incidence and severity of adverse events (AEs) including immune effector cell-associated neurotoxicity syndrome (ICANS), cytokine release syndrome (CRS) and other AEs as well as medications used for prophylaxis and management of adverse events will be reported.
Time frame: Baseline (Day 1) up to end of treatment (up to 40 months)
Treatment patterns including healthcare setting and treatment schedules will be reported.
Contact information is provided by the study sponsor or research team.
Janssen-Cilag Ltd.
Industry
64007957MMY4004: 64007957MMY4004 - REALiTEC
Acronym: REALiTEC/TAL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07497165
Blood Protein Disorders, Cardiovascular Diseases
Taiyuan, Shanxi, China
View Trial DetailsNCT07667868
Blood Protein Disorders, Cardiovascular Diseases
View Trial DetailsNCT07609940
Blood Protein Disorders, Cardiovascular Diseases
View Trial DetailsNCT07185490
Blood Protein Disorders, Cardiovascular Diseases
View Trial Details