Dara-BCD for Rare MGRS

NCT ID: NCT06771180

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2026-06-30

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.

Conditions

Monoclonal Gammopathy of Renal Significance (MGRS)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dara-CyBorD

Daratumumab Cyclophosphamide Bortezomib Dexamethasone

Group Type: EXPERIMENTAL

Dara-CyBorD

Intervention Type: DRUG

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

Interventions

Dara-CyBorD

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

Intervention Type: DRUG

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin Lu, MD

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Yang Liu

Role: CONTACT

pkuphliuyang@bjmu.edu.cn

86-13716926210

Other Identifiers

2024PHB134-002

Identifier Type: -

Identifier Source: org_study_id