A Real-World Observational Study: Zevorcabtagene Autoleucel Injection in Patients with Relapsed/Refractory Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zevorcabtagene Autoleucel.
- Who it may be relevant to
- Registry conditions: Relapsed/Refractory Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Zevorcabtagene Autoleucel
Zevorcabtagene Autoleucel is a novel fully human BCMA-targeting CAR-T therapy
Primary outcome measures
- To evaluate long-term survival benefits of zevor-cel in subjects with R/R MM [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
1\. There were no specific exclusion criteria for this study。
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06659770 · CT053-MM-05