Study on CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab for Kidney Disease Related to Monoclonal Gammopathy

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT06083922

This clinical trial is testing a combination of drugs, including CyBorD and daratumumab, to see if they are safe and effective for treating kidney disease linked to monoclonal gammopathy, such as cast nephropathy associated with multiple myeloma.

Patient Parameters

Program Overview

The aim of this study is to determine if a combination of drugs—cyclophosphamide, bortezomib, dexamethasone (CyBorD), and daratumumab—is a safe and effective treatment for kidney disease associated with monoclonal gammopathy, including conditions like cast nephropathy linked to multiple myeloma.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of kidney disease related to monoclonal gammopathy, such as cast nephropathy or other related conditions.
  • For cast nephropathy: Must have newly diagnosed multiple myeloma and measurable disease based on specific lab tests.
  • For other kidney diseases: Must have a confirmed diagnosis by kidney biopsy and evidence of monoclonal gammopathy.
  • Must have a certain level of kidney function and meet specific blood test criteria.
  • Must not have recent exposure to substances harmful to kidneys or evidence of kidney blockage.
  • Must have adequate blood and liver function based on lab tests.
  • Women must not be pregnant and must agree to use effective birth control during the study.
  • Men must agree to use effective birth control during the study.
  • Must be willing to follow study procedures and attend scheduled visits.

Exclusion Criteria

  • Have kidney disease linked to conditions other than plasma cell disorders.
  • Have certain other medical conditions like plasma cell leukemia or amyloidosis.
  • Have received previous treatments for plasma cell disorders.
  • Are pregnant or breastfeeding.
  • Have had major surgery or certain treatments recently.
  • Have uncontrolled infections or significant heart disease.
  • Have allergies to study medications.
  • Have other active cancers, except for certain skin or cervical cancers.
  • Have severe nerve damage or lung disease.
  • Are taking certain medications that affect the liver or immune system.
  • Have certain viral infections like hepatitis B or C, or HIV.
  • Have received live vaccines recently.

Locations

FACILITYZIPCITYSTATE
Tufts Medical Center (Data Collection Only)02111BostonMassachusetts
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)07920Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)11725CommackNew York
Memorial Sloan Kettering Westchester (Limited Protocol Activities)10604HarrisonNew York
Weill Cornell Medical Center (Data Collection Only)10021New YorkNew York
Mount Sinai Hospital (Data Collection Only)10029New YorkNew York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)10065New YorkNew York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)11553UniondaleNew York

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