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

NCT06369935 | Not Yet Recruiting

• 1 other identifier: 20240407
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relapsed/Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Best Overall Response Rate， BOR

  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.

  up to 24 weeks

Secondary Outcomes (5)

• PFS rate of 6 month

  up to 24 weeks

• OS rate of 6 month

  up to 24 weeks

• Time to Response， TTR

  up to 24 weeks

• Time to Complete Response， TTCR

  up to 24 weeks

• Adverse Event， AE

  up to 24 weeks

Interventions

Equecabtagene Autoleucel DRUG

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

Also known as: CT103A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target population of this study was adult patients with relapsed/refractory multiple myeloma who were treated in real world with equecabtagene autoleucel, a commercially available product.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Samples

MeSH Terms

Conditions

Multiple Myeloma

Interventions

CT103A chimeric antigen receptor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jin Lu

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Liu, Doctor

CONTACT

+8613716926210; pkuphliuyang@bjmu.edu.cn

Jin Lu

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 17, 2024
• Study Start: June 20, 2024
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): August 20, 2027
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)