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This is an open-label, multicenter, phase 2 study in subjects with newly diagnosed proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMIDs), OR light chain proximal tubulopathy (LCPT), OR thrombotic Microangiopathy (TMA), OR cryoglobulinemic glomerulonephritis, (CGGN), treated with daratumumab, bortezomib, cyclophosphamide, and dexamethasone.
The current study aims to investigate daratumumab, bortezomib, cyclophosphamide, and dexamethasone regimen in patients with newly diagnosed PGNMIDs, LCPT, TMA, CGGN. Approximately 10 subjects will receive primary therapy with daratumumab-CyBorD. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dara-CyBorD | Experimental | Daratumumab Cyclophosphamide Bortezomib Dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dara-CyBorD | Drug | Dara-CyBorD will be used for newly diagnosed PGNMID, OR LCPT, OR TMA OR CGGN. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Hematologic Complete Response at the completion of 6 cycles | Hematologic complete response requires absence of monoclonal protein by immunofixation electrophoreses of both serum and urine as well as a normal FLC ratio (FLCr). CR is considered when FLCr was altered in favour of the non-amyloidogenic, uninvolved FLC (uFLC), even though the ratio may not have been normalised. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Hematologic CR (Complete Response)+ VGPR (very good partial response) at the completion of 6 cyels | 6 months | |
| Rate of Hematologic ORR (Overall Response, CR+VGPR+low-dFLC response+PR) at the completion of 6 cyels | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Liu | Contact | 86-13716926210 | pkuphliuyang@bjmu.edu.cn |
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| Renal response at 6 months | 6 months |
| MRD status at 6 months | 6 months |
| Renal Survival in 2 years | 2 years |
| Overall Survival in 2 years | 2 years |
| TRAEs | Treatment-related adverse events up to 2 years | 2 years |