A Phase 2 interventional study of Dara-CyBorD in Monoclonal Gammopathy of Renal Significance, sponsored by Peking University People's Hospital. Recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Peking University People's Hospital · Phase 2, Interventional, and Treatment
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.
174 studies on the registry are indexed under Immunoglobulin Light-chain Amyloidosis; 58 are open to participants now.
This study's planned enrollment of 20 is below the median of 37 across 124 interventional studies indexed under Immunoglobulin Light-chain Amyloidosis.
Browse Immunoglobulin Light-chain Amyloidosis studies →Peking University People's Hospital is the lead sponsor of 603 studies on the registry; 241 are open to participants now.
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Exclusion Criteria:
Daratumumab: Cyclophosphamide Bortezomib Dexamethasone
Drug: Dara-CyBorD
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.
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.
Time frame: 6 months
Rate of Hematologic CR (Complete Response)+ VGPR (very good partial response) at the completion of 6 cyels
Time frame: 6 months
Rate of Hematologic ORR (Overall Response, CR+VGPR+low-dFLC response+PR) at the completion of 6 cyels
Time frame: 6 months
Renal response at 6 months
Renal response at 6 months
Time frame: 6 months
Cardiac response at 6 months
Cardiac response (for patients with cardiac involvement) at 6 months
Time frame: 6 months
MRD status at 6 months
Minimal residual disease status at 6 months
Time frame: 6 months
Renal Survival in 2 years
Renal Survival in 2 years
Time frame: 2 years
Overall Survival in 2 years
Overall Survival in 2 years
Time frame: 2 years
TRAEs
Treatment-related adverse events up to 2 years
Time frame: 2 years
Plan to share: No
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