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The purpose of this study is to compare the efficacy between CM336 and investigator's choice Standard of Care in relapsed or refractory multiple myeloma (RRMM) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: CM336 | Experimental |
| |
| Arm B: Standard of Care Regimens | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM336 Injection | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | The progression-free survival (PFS) evaluated by Blinded Independent Central Review (BICR) | Up to 4 years |
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Inclusion Criteria:
The subjects voluntarily sign the informed consent form (ICF) and agree to abide by the provisions of this protocol.
Age ≥ 18 years old, gender is not limited.
Eastern Cooperative Oncology Group performance status score (ECOG) 0-2 points.
Patients with relapsed or refractory multiple myeloma who have received at least two lines of anti-myeloma treatment previously, and must include at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-Cluster of Differentiation 38(CD38) monoclonal antibody.
The subject has evidence of disease progression or has not achieved remission after the last line of treatment, as determined by the investigator based on the International Myeloma Working Group (2016) criteria.
The subject has measurable disease at the screening period, meeting at least one of the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Jia | Contact | 86+028-88610620 | qianjia@keymedbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Lugui Qiu | Chinese Academy of Medical Sciences | Principal Investigator |
| Gang An | Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Tianjin | Tianjin Municipality | 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 |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard Of Care( SOC) |
| Drug |
Specified dose on specified days |
|
| 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 |