RecruitingPhase 2NCT06083922

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

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

20 participants

Start Date

Oct 16, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of four drugs — cyclophosphamide, bortezomib, dexamethasone, and daratumumab — in patients with a condition called monoclonal gammopathy of renal significance (MGRS), in which abnormal proteins produced by plasma cells cause kidney damage. This includes patients with kidney-damaging forms of multiple myeloma as well. **You may be eligible if...** - You are 18 or older - You have a kidney biopsy-confirmed diagnosis of MGRS-related kidney disease or myeloma-related kidney cast nephropathy - Your kidney function is significantly reduced (eGFR below 40) - Your blood counts, liver function, and other lab values meet required minimums - You are willing to use contraception as required **You may NOT be eligible if...** - You have MGRS linked to conditions other than plasma cell disease (e.g., leukemia or Waldenstrom's) - You have AL amyloidosis, plasma cell leukemia, or POEMS syndrome - You have previously received treatment targeting the plasma cell disorder - You have HIV, active hepatitis B or C, or cirrhosis - You have significant peripheral neuropathy (nerve damage) - You had major surgery or radiation in the past 2 weeks - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

Days 1, 8 and 15, Cycles 1-8

DRUGBortezomib

Days 1,8,15, Cycles 1-8, Days 1,15 Cycles 9+

DRUGDexamethasone

Days 1,2,8, 9,15,16, 22, 23, Cycles 1-8

DRUGDaratumumab

Days 1,8,15,22, Cycles 1-2, Days 1,15 Cycles 3-6, Day 1 Cycles 7+


Locations(11)

Tufts Medical Center (Data Collection Only)

Boston, Massachusetts, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Weill Cornell Medical Center (Data Collection Only)

New York, New York, United States

Mount Sinai Hospital (Data Collection Only)

New York, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

University of North Carolina (Data Collection Only)

Chapel Hill, North Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06083922


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