A Real-World Observational Study: Zevorcabtagene Autoleucel Injection in Patients with Relapsed/Refractory Multiple Myeloma
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Registration Number
- NCT06659770
- Lead Sponsor
- CARsgen Therapeutics Co., Ltd.
- Brief Summary
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.
- Detailed Description
Primary study endpoints:
Overall Survival Rate (OS Rate) at 24 months after infusion：Survival rate from the start of cell infusion to 24 months after infusion.
Secondary study endpoints:
Incidence and Severity of Treatment-Related Adverse Events (TEAEs) for zevor-cel Incidence and severity of adverse events (AEs) related to study treatment Incidence of serious adverse events (SAEs) related to study treatment
Other efficacy endpoints of zevor-cel:
Overall response rate (ORR)：Proportion of subjects with a partial response (PR) or above.
Complete response or stringent complete response rate (CR/sCR) ：The proportion of subjects with the best response of CR/sCR.
Duration of Response (DOR)：The time from first response to disease progression or death caused by any reasons in subjects with the best response of PR and above.
Progression Free Survival (PFS) Overall survival (OS)： The time from the start of cell infusion to death due to any cause.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- There were no specific exclusion criteria for this study。
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate long-term survival benefits of zevor-cel in subjects with R/R MM 24 months 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.
- Secondary Outcome Measures
Name Time Method