Clinical trial NCT06771180: Dara-BCD for Rare MGRS
Official title: Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with Rare Monoclonal Gammopathies of Renal Significance
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Monoclonal Gammopathy of Renal Significance (MGRS)
Keywords: PGNMIDs
LCPT
TMA
CGGN
daratumumab
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of PGNMIDs, OR LCPT, OR TMA, OR CGGN.
2. Evidence of clonal plasma cell in bone marrow.
3. ECOG 0,1,2
4. Neu≥ 1.0\*10\^9/L, HGB ≥70g/L, PLT ≥ 50\*10\^9/L.
5. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
6. Informed consent explained to, understood by and signed by the patient.

Exclusion Criteria:

1. Prior therapy for MGRS, with the exception of equal or less than 160 mg dexamethasone (or equivalent corticosteroid)
2. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
3. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
4. Severe or persistent infection that cannot be effectively controlled;
5. Presence of severe autoimmune diseases or immunodeficiency disease;
6. Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]); Patients with HIV infection or syphilis infection;
7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Primary outcomes:
measure: Rate of Hematologic Complete Response at the completion of 6 cycles
timeFrame: 6 months
Secondary outcomes:
measure: Rate of Hematologic CR (Complete Response)+ VGPR (very good partial response) at the completion of 6 cyels
timeFrame: 6 months
measure: Rate of Hematologic ORR (Overall Response, CR+VGPR+low-dFLC response+PR) at the completion of 6 cyels
timeFrame: 6 months
measure: Renal response at 6 months
timeFrame: 6 months
measure: MRD status at 6 months
timeFrame: 6 months
measure: Renal Survival in 2 years
timeFrame: 2 years
measure: Overall Survival in 2 years
timeFrame: 2 years
measure: TRAEs
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References: