A Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab in People With M… (NCT06083922) | Clinical Trial Compass
RecruitingPhase 2
A Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab in People With Monoclonal Gammopathy of Renal Significance (MGRS)
United States20 participantsStarted 2023-10-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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, provided the serum FLC ratio is abnormal.
* eGFR must be \<40 ml/min/1.73m2
* Subjects must have histologically confirmed diagnosis of monoclonal gammopathy associated CN by kidney biopsy OR If a kidney biopsy is not available, a percentage of urine albumin excretion (%UAE) \< 25 % AND FLC \> 50 mg/dL
Inclusion criteria for other MGRS associated renal diseases
* Histologically confirmed diagnosis of MGRS-associated renal disease by kidney biopsy
* Presence of monoclonal gammopathy by serum protein electrophoresis, Immunofixation, or Free Light Chain Assay
* Evidence of plasma cell dyscrasia by bone marrow biopsy confirming clonal plasma cell population
* eGFR \<40 ml/min/1.73m2 or 24h urine total protein \> 1gm
Inclusion criteria for both cast nephropathy associated with MM and other MGRS associated renal diseases
* Subjects must be ≥ 18 years of age at time of registration.
* Subj…