A Phase 2 Study of Cyclophosphamide, Bortezomib, Dexamethasone, and Daratumumab in People With Monoclonal Gammopathy of Renal Significance

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Full Title

A Phase II Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab for Patients with Monoclonal Gammopathy of Renal Significance (MGRS)

Purpose

Researchers are assessing several drugs given together to treat monoclonal gammopathy of renal significance (MGRS). MGRS happens when you have an abnormal protein (called M-protein) in your blood and it damages your kidneys.

The drugs used in this study are cyclophosphamide, bortezomib, and dexamethasone (CyBorD) plus daratumumab. Researchers want to see how well they work in people with MGRS and if they cause any side effects. Cyclophosphamide is given intravenously (by vein) and daratumumab and bortezomib are injections given under the skin. Dexamethasone is taken orally (by mouth) or given intravenously.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have MGRS or multiple myeloma with cast nephropathy.
  • Have not received any treatment for this condition.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Hani Hassoun’s office at 646-608-3718.

Protocol

22-424

Phase

Phase II (phase 2)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06083922