NCT06083922

A Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab in People With Monoclonal Gammopathy of Renal Significance (MGRS)

A Phase II Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab for Patients With Monoclonal Gammopathy of Renal Significance (MGRS)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether cyclophosphamide, bortezomib, dexamethasone (CyBorD) with daratumumab SC is a safe treatment combination for MGRS-associated kidney disease including cast nephropathy associated with multiple myeloma. In addition, the researchers will find out whether the study drug combination is an effective treatment for these conditions.

Conditions

• Multiple Myeloma
• Monoclonal Gammopathy of Renal Significance

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Days 1, 8 and 15, Cycles 1-8
DRUG	Bortezomib	Days 1,8,15, Cycles 1-8, Days 1,15 Cycles 9+
DRUG	Dexamethasone	Days 1,2,8, 9,15,16, 22, 23, Cycles 1-8
DRUG	Daratumumab	Days 1,8,15,22, Cycles 1-2, Days 1,15 Cycles 3-6, Day 1 Cycles 7+

Timeline

• Start date: 2023-10-16
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2023-10-16
• Last updated: 2026-04-16

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study