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NCT Number: NCT06369935

A Real World Study of Equecabtagene Autoleucel in Subjects With Relapsed and Refractory Multiple Myeloma.

This study is a multicenter, observational, single-arm real world study. The purpose of this study is to describe demographic and disease characteristics, treatment patterns, and clinical outcomes in the real-world setting among participants in China with relapsed/refractory multiple myeloma (RRMM) who have been treated with Equecabtagene Autoleucel. This study will use both prospective and retrospective data

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Key information

About this study

Primary endpoint:

Best Overall Response Rate (BOR): The proportion of patients who receive treatment with Ikeolensay injection and have been evaluated by researchers as having the best disease status is strict complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).

Secondary endpoint:

Progress Free Survival (PFS) rate at 6 months: The probability of patients not experiencing disease progression or death from any cause after receiving treatment with Ikeolensay injection for 6 months; Overall survival (OS) rate at 6 months: the probability of survival of patients after receiving treatment with Ikeolensay injection for 6 months; Time to Response (TTR): The time interval between the patient receiving treatment with Ikeolensay injection and the first recorded time of disease remission; Time to Complete Response (TTCR): The time interval between the patient receiving treatment with Ikeolensay injection and the first recording of complete disease response (CR or sCR); Adverse Event (AE): After receiving treatment with Ikeolensay Injection, researchers consider all adverse events and serious adverse events (SAE) related to Ikeolensay Injection treatment; Hospitalization: After receiving treatment with Ikeolensay injection, the researcher considers any hospitalization related to Ikeolensay injection treatment (including the reason, duration, and outcome of hospitalization); Death: The death of the patient after receiving treatment with Ikeolensay injection, recording the date and cause of death (any reason); Secondary malignant tumors: For any secondary malignant tumors discovered during the monitoring process, researchers can obtain tumor biopsy samples and other necessary samples of tumor tissue according to clinical needs, relevant guiding principles, and product instructions for safety analysis; Quality of life: Evaluate the quality of life using the EQ-5D and EORTCQLQ C30 scoring standards; Medical resource utilization: Collect any medical resource utilization information related to the treatment of patients with Ikeolensay injection (including hospitalization, emergency, outpatient, and new prescription drug usage).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients with confirmed relapsed/refractory multiple myeloma;
  • Based on clinical practice, the physician decided to administer equecabtagene autoleucel treatment;
  • Voluntarily sign the informed consent form approved by the ethics committee.

Exclusion criteria

  • Patients who are hypersensitive to the active ingredients of the product or any excipients (dimethyl sulfoxide, compound electrolyte injection, human albumin);
  • The researcher believes that patients are unable to return for follow-up visits or that it is impossible to complete the study;
  • Patients with expected survival less than 3 months

Treatment and study plan

Equecabtagene Autoleucel

Drug

Equecabtagene Autoleucel (CT103A) is a novel fully human BCMA-targeting CAR-T therapy

Other names: CT103A

Primary outcomes

  1. Best Overall Response Rate, BOR

    Time frame: up to 24 weeks

    Patients treatmented with Equecabtagene Autoleucel, the optimal disease state evaluated by the researcher is strict complete response (sCR),complete response (CR), very good partial response (Very Good Partial Response (VGPR) or partial response (partial response,PR) rate.

Secondary outcomes

  1. PFS rate of 6 month

    Time frame: up to 24 weeks

    Probability of patients not experiencing disease progression or death from any cause 6 months after starting treatment with equecabtagene autoleucel

  2. OS rate of 6 month

    Time frame: up to 24 weeks

    Probability of patient survival 6 months after equecabtagene autoleucel treatment

  3. Time to Response, TTR

    Time frame: up to 24 weeks

    From the time the patient received equecabtagene autoleucel to the first recorded remission of the disease

  4. Time to Complete Response, TTCR

    Time frame: up to 24 weeks

    From the time the patient received equecabtagene autoleucel to the first recorded complete remission of the disease (time interval between CR or sCR)

  5. Adverse Event, AE

    Time frame: up to 24 weeks

    After the patient received treatment with equecabtagene autoleucel, the investigators considered all adverse events and serious adverse events (SAE) related to the treatment with Equecabtagene Autoleucel.

Study contacts

Contact information is provided by the study sponsor or research team.

Jin Lu

CONTACT

Yang Liu, Doctor

CONTACT

[email protected]

+8613716926210

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 17, 2024
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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