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The purpose of this study is to compare the efficacy of GR1803 Injection with daratumumab in combination with pomalidomide and dexamethasone (DPd).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: GR1803 Injection | Experimental |
| |
| Arm B: DPd | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GR1803 injection | Drug | Participants received intravenous GR1803 injection at a dose of 180 ug per kilogram, which had been preceded by step-up doses of 10 and 30 ug per kilogram. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Up to 5 years | |
| Progression Free Survival on Next-line Therapy (PFS2) | Up to 5 years | |
| Overall Response (Partial Response [PR] or Better) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang An | Contact | 13502181109 | angang@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences | Recruiting | Tianjin | China |
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| Daratumumab | Drug | Participants received subcutaneous Daratumumab at a dose of 1800 mg. |
|
| Pomalidomide | Drug | Participants received Pomalidomide at a dose of 4 mg on days 1 to 21 of each cycle (28 days). |
|
| Dexamethasone | Drug | Participants received once-weekly dexamethasone at a dose of 40 mg (≤75 years) or 20 mg (>75 years). |
|
| Up to 5 years |
| Complete Response (CR) or Better | Up to 5 years |
| Duration of Response | Up to 5 years |
| Duration of Complete Response | Up to 5 years |
| Time to Response | Up to 5 years |
| Minimal Residual Disease (MRD)-negativity | Up to 5 years |
| Number of Participants with Adverse Events (AEs) by Severity | Up to 5 years |
| Serum Concentration of GR1803 Injection | Up to 5 years |
| Number of Participants with Anti-drug Antibodies (ADAs) to GR1803 Injection | Up to 5 years |
| Change from Baseline in Overall Health-related Quality of Life as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) | The EQ-5D-5L ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). | Up to 5 years |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| 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 |
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| ID | Term |
|---|---|
| C556306 | daratumumab |
| C467566 | pomalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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