The purpose of this study is to describe the use of teclistamab/talquetamab in the treatment of patients with RRMM outside of clinical trials.
Study Type
OBSERVATIONAL
Enrollment
900
No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.
No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.
Describe Baseline Characteristics of Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who Received Teclistamab/ Talquetamab Outside of Clinical Trials
Participants' demographics and disease characteristics (age, co-morbidities, renal function), and prior antimyeloma therapies will be reported.
Time frame: Baseline (Day 1)
Overall Response Rate (ORR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
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 in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
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 in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
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
Duration of Response (DOR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
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
Minimal Residue Assessment (MRD) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Aalborg Sygehus Syd
Aalborg, Denmark
RECRUITINGAarhus Universitetshospital
Aarhus N, Denmark
COMPLETEDRigshospitalet
Copenhagen, Denmark
COMPLETEDOdense University Hospital
Odense, Denmark
COMPLETEDSygehus Lillebælt, Vejle
Vejle, Denmark
RECRUITINGHopital Albert Calmette - CHU Lille
Lille, France
RECRUITINGInstitut Paoli Calmettes
Marseille, France
COMPLETEDCHU de Nantes hotel Dieu
Nantes, France
RECRUITINGHopital Saint Louis
Paris, France
COMPLETEDInstitut Universitaire du Cancer Toulouse Oncopole
Toulouse, France
RECRUITING...and 58 more locations
Number of participants with MRD negative rate will be assessed.
Time frame: Up to 40 months
Overall Survival (OS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
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: From the date of first dose of teclistamab/talquetamab to the date of the participant's death (up to 40 months)
Progression Free Survival (PFS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
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
Time to Next Treatment (TTNT) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials
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: Up to 40 months
Describe the Safety Management of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials
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)
Describe the Use of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials
Treatment patterns including healthcare setting and treatment schedules will be reported.
Time frame: Baseline (Day 1) up to end of treatment (up to 40 months)