About this trial
This study is a single-arm, open-label, multicenter, post-marketing, Phase IV, prospective, observational clinical trial to evaluate the efficacy and safety of the post-marketing product zevor-cel as treatment for subjects with R/R MM in the real world.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years;
Subjects with refractory/relapsed multiple myeloma who meet product indication criteria and have received commercialized zevor-cel infusion.
Voluntary participation in this study and willingness to sign the informed consent form, for subjects incapable to provide consent, informed consent must be obtained from their legally acceptable guardians.
Disqualifiers
None
Trial population
This study was conducted in a medical institution that has been commercially evaluated and certified. Before carrying out the corresponding procedures for the study, the informed consent signed by the subjects themselves must be obtained, and for patients who do not have full civil capacity, the informed consent of their guardians must be obtained.
Trial design
Cohort
Prospective
Treatments tested in this trial
Zevorcabtagene Autoleucel
DrugZevorcabtagene Autoleucel is a novel fully human BCMA-targeting CAR-T therapy
Treatment groups
Trial outcomes
Primary outcomes
To evaluate long-term survival benefits of zevor-cel in subjects with R/R MM
Statistical analysis of OS will be performed, survival curves of OS will be plotted, and 1-year and 2-year survival rates will be calculated. The median, 25% quantile, and 75% quantile of OS will be calculated with their 95% confidence intervals.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: