Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04614558

Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance

Led by Columbia University · Updated on 2025-06-06

27

Participants Needed

2

Research Sites

259 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

G

Genzyme, a Sanofi Company

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to see whether Isatuximab can help improve kidney function of participants with MGRS. Isatuximab is approved by the Food and Drug Administration (FDA) for the treatment of adult patients with multiple myeloma, but it is not approved by the FDA to treat MGRS. This means that the use of isatuximab in this study is considered 'investigational'.

CONDITIONS

Official Title

Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Renal biopsy confirmed diagnosis of MGRS disorder such as PGNMID, C3 glomerulopathy with monoclonal gammopathy, non-amyloid fibrillary glomerulonephritis, light chain proximal tubulopathy, or immunotactoid glomerulopathy
  • Concurrent monoclonal gammopathy confirmed by serum or urine protein electrophoresis or bone marrow biopsy for patients with C3 glomerulopathy
  • Measurable proteinuria of at least 1 gram over 24 hours
  • Newly diagnosed patients or those with previous therapy but persistent renal dysfunction and proteinuria
  • No prior CD38 antibody therapy
  • Washout period of 12 weeks for chemotherapy and 24 weeks for Rituximab therapies before starting study treatment
  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Life expectancy greater than 6 months
  • Normal organ and marrow function with leukocytes ≥3,000/mcL, neutrophils ≥1,500/mcL, platelets ≥100,000/mcL, normal total bilirubin, AST/ALT ≤2.5 times upper normal limit, and estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2
Not Eligible

You will not qualify if you...

  • Chemotherapy within 12 weeks or Rituximab within 24 weeks before starting study treatment
  • Receiving any other investigational agents during the study
  • History of severe allergic reactions to drugs similar to Isatuximab
  • Diagnosis of multiple myeloma, high risk smoldering multiple myeloma, or B cell lymphoma requiring therapy
  • Renal biopsy showing other significant diagnoses like diabetic nephropathy
  • Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting study compliance
  • Pregnant or breastfeeding women
  • HIV-positive status due to increased infection risk with immunosuppressive therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Massachusetts General Hospital, Renal Associates Clinic

Boston, Massachusetts, United States, 02114

Actively Recruiting

2

Columbia University Irving Medical Center

New York, New York, United States, 10032

Actively Recruiting

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Research Team

R

Research Nurse Navigator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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