A Phase II Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab for Patients With Monoclonal Gammopathy of Renal Significance (MGRS)
Memorial Sloan Kettering Cancer Center
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Inclusion criteria for cast nephropathy associated with MM: * Subjects must have a confirmed diagnosis of NDMM as per standard IMWG criteria * Subjects must have measurable disease, defined as meeting at least 1 of the following criteria ≤ 14 days prior to registration: * A monoclonal Immunoglobulin (M-protein) concentration on serum protein electrophoresis (SPEP) of ≥ 0.5 g/dL. * Measurable urinary light chain secretion by quantitative analysis using urine protein electrophoresis (UPEP) of ≥ 200 mg/24 hours. * Involved serum free light chain (FLC) level ≥ 10 mg/dL…