Dara-BCD for Rare MGRS

NCT06771180 | Not Yet Recruiting Phase 2

• 1 other identifier: 2024PHB134-002
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Monoclonal Gammopathy of Renal Significance (MGRS)

Keywords

PGNMIDs; LCPT; TMA; CGGN; daratumumab

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 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

• Renal response at 6 months

  6 months

• MRD status at 6 months

  6 months

• Renal Survival in 2 years

  2 years

Study Arms (1)

Dara-CyBorD

EXPERIMENTAL

Daratumumab Cyclophosphamide Bortezomib Dexamethasone

Drug: Dara-CyBorD

Interventions

Dara-CyBorD DRUG

Dara-CyBorD will be used for newly diagnosed PGNMID, OR LCPT, OR TMA OR CGGN.

Dara-CyBorD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Central Study Contacts

Yang Liu

CONTACT

86-13716926210; pkuphliuyang@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 13, 2025
• Study Start: January 15, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share