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

October 24, 2024 updated by: CARsgen Therapeutics Co., Ltd.
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study 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.

Description

Inclusion Criteria:

  1. Age ≥ 18 years;
  2. Subjects with refractory/relapsed multiple myeloma who meet product indication criteria and have received commercialized zevor-cel infusion.
  3. 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。

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate long-term survival benefits of zevor-cel in subjects with R/R MM
Time Frame: 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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CARsgen Therapeutics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT053-MM-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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