A Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab in People With Monoclonal Gammopathy of Renal Significance (MGRS)
NCT06083922 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-04-16
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
- DRUG
-
Days 1, 8 and 15, Cycles 1-8
- DRUG
-
Days 1,8,15, Cycles 1-8, Days 1,15 Cycles 9+
- DRUG
-
Days 1,2,8, 9,15,16, 22, 23, Cycles 1-8
- DRUG
-
Days 1,8,15,22, Cycles 1-2, Days 1,15 Cycles 3-6, Day 1 Cycles 7+
Sponsors & Collaborators
-
Janssen Pharmaceuticals
collaborator INDUSTRY -
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Hani Hassoun, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-16
- Primary Completion
- 2026-10-31
- Completion
- 2026-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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