RecruitingMultiple MyelomaMonoclonal Gammopathy of Renal Significance
A Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab in People With Monoclonal Gammopathy of Renal Significance (MGRS)
Eligible age
18+ yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Memorial Sloan Kettering Cancer Center
You may qualify if…
- ✓ 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
- ✓ Histologically confirmed diagnosis of MGRS-associated renal disease by kidney biopsy
You may not qualify if…
- ✕ MGRS associated with diseases other than plasma cell dyscrasia (e.g. CLL, B-cell neoplasm, Waldenstrom's macroglobulinemia…)
- ✕ Plasma cell leukemia, AL amyloidosis, or POEMS syndrome.
- ✕ Treatment with prior drugs aimed at the plasma cell dyscrasia.
- ✕ Treatment with prior or concurrent investigational agents aimed at the plasma cell dyscrasia.
- ✕ Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- ✕ Major surgery ≤ 14 days before registration.
- ✕ Focal radiation therapy within 14 days prior to registration with the exception of palliative- radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma.
- ✕ Disease-related central nervous system involvement.
Where it's recruiting
Massachusetts
Boston
New Jersey
Basking Ridge · Middletown · Montvale
New York
Commack · Harrison · New York · Uniondale
North Carolina
Chapel Hill
Source: ClinicalTrials.gov · NCT06083922 · last updated 2026-07-06