A Real-World Observational Study: Zevorcabtagene Autoleucel Injection in Patients with Relapsed/Refractory Multiple Myeloma

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCARsgen Therapeutics Co., Ltd.

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Zevorcabtagene Autoleucel

    Drug

    Zevorcabtagene Autoleucel is a novel fully human BCMA-targeting CAR-T therapy

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
24 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: