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

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.

Trial Details

NCT ID
NCT06083922
Phase
PHASE2
Sponsor
Memorial Sloan Kettering Cancer Center
Status
RECRUITING
Cancer Type
Multiple Myeloma
Interventions
  • Cyclophosphamide
  • Bortezomib
  • Dexamethasone
  • Daratumumab
Locations (sample)
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Basking Ridge, New Jersey, United States|40.70621,-74.54932
  • Middletown, New Jersey, United States|40.39428,-74.11709
  • Montvale, New Jersey, United States|41.04676,-74.02292
  • Commack, New York, United States|40.84288,-73.29289

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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