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This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed monoclonal immunoglobulin deposition disease treated with daratumumab, bortezomib, cyclophosphamide, and dexamethasone.
The current study aims to investigate daratumumab, bortezomib, cyclophosphamide, and dexamethasone regimen in patients with newly diagnosed monoclonal immunoglobulin deposition disease. Approximately 25 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 | Patient will receive Dara-CyBorD (Daratumumab, Bortezomib, Cyclophosphamide, Dexamethasone) for at least 6 cycles, and then Daratumumab maintainance. Drug: Daratumumab: 16mg/kg IV dose OR 1800 mg subcutaneously Drug: Cyclophosphamide: 300 mg/m^2 as an oral or IV dose Drug: Bortezomib: 1.3 mg/m^2 as an subcutaneous (SC) injection. Drug: Dexamethasone: 20-40mg Patients will receive the above drugs (Dara-CyBorD) on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles. Daratumumab will be administered weekly for the first 8 weeks (2 cycles), then every 2 weeks for 4 cycles (cycles 3-6), and then every 4 weeks until progression of disease or subsequent therapy for a maximum of 1 years. Note: If patients achieve less than hematologic VGPR by cycle 3 or less than PR by cycle 2, treatment plan will be allowed to discontinued, according to treatment principle in systemic light chain amyloidosis. |
| 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 | |
|---|---|---|---|---|
| Jin Lu | Contact | 86-13311491805 | jin1lu@sina.com | |
| Yang Liu | Contact | 86-13716926210 | pkuphliuyang@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jin Lu | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100005 | China |
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| ID | Term |
|---|---|
| D000075363 | Immunoglobulin Light-chain Amyloidosis |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000686 | Amyloidosis |
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|
| Renal response at 6 months | Renal response at 6 months | 6 months |
| Cardiac response at 6 months | Cardiac response (for patients with cardiac involvement) at 6 months | 6 months |
| MRD status at 6 months | Minimal residual disease status at 6 months | 6 months |
| Renal Survival in 2 years | Renal Survival in 2 years | 2 years |
| Overall Survival in 2 years | Overall Survival in 2 years | 2 years |
| TRAEs | Treatment-related adverse events up to 2 years | 2 years |
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
|
| The First Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510062 | China |
|
| D057165 |
| Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010265 | Paraproteinemias |