Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with MIDD

Phase 2

Recruiting

• Conditions: Monoclonal Gammopathy of Renal Significance
• Interventions: Drug: Dara-CyBorD

• Registration Number: NCT06418477
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-05-13
• Study First Submitted QC: 2024-05-13
• Study First Posted: 2024-05-17
• Study Start: 2024-06-15
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-29
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Diagnosis of monoclonal immunoglobulin deposition disease without anti-plasma cell treatment
2. ECOG 0,1,2
3. Neu≥ 1.0*10^9/L, HGB ≥70g/L, PLT ≥ 50*10^9/L.
4. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
5. Informed consent explained to, understood by and signed by the patient.

Exclusion Criteria

1. Prior therapy for MIDD, 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+]);
7. Patients with HIV infection or syphilis infection;
8. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dara-CyBorD	Dara-CyBorD	Daratumumab: Cyclophosphamide Bortezomib Dexamethasone

Primary Outcome Measures

Name	Time	Method
Rate of Hematologic Complete Response at the completion of 6 cycles	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Renal response at 6 months	6 months	Renal response at 6 months
Renal Survival in 2 years	2 years	Renal Survival in 2 years
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
Cardiac response at 6 months	6 months	Cardiac response (for patients with cardiac involvement) at 6 months
MRD status at 6 months	6 months	Minimal residual disease status at 6 months
Overall Survival in 2 years	2 years	Overall Survival in 2 years
TRAEs	2 years	Treatment-related adverse events up to 2 years

Trial Locations

Locations (3)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China