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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
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Equecabtagene Autoleucel | Drug | Equecabtagene Autoleucel (CT103A) is a novel fully human BCMA-targeting CAR-T therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PFS rate of 6 month | Probability of patients not experiencing disease progression or death from any cause 6 months after starting treatment with equecabtagene autoleucel | up to 24 weeks |
| OS rate of 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Liu, Doctor | Contact | +8613716926210 | pkuphliuyang@bjmu.edu.cn | |
| Jin Lu | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Jin Lu | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C000720487 | CT103A chimeric antigen receptor |
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Blood Samples
Probability of patient survival 6 months after equecabtagene autoleucel treatment
| up to 24 weeks |
| Time to Response, TTR | From the time the patient received equecabtagene autoleucel to the first recorded remission of the disease | up to 24 weeks |
| Time to Complete Response, TTCR | From the time the patient received equecabtagene autoleucel to the first recorded complete remission of the disease (time interval between CR or sCR) | up to 24 weeks |
| Adverse Event, AE | 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. | up to 24 weeks |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |