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Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance
Sponsor: Columbia University
Summary
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'.
Official title: A Single Arm, Multicenter, Phase II, Open-Label Trial to Evaluate Efficacy of Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
27
Start Date
2021-06-08
Completion Date
2026-06
Last Updated
2025-06-06
Healthy Volunteers
No
Conditions
Interventions
Isatuximab
Isatuximab in IV form (10mg/kg q weekly x 4 doses followed by 10mg/kg q 2 weeks) for a total of 6 month duration. Doses should be initiated at 175 mg/hour up to a maximum of 400 mg/hour. Isatuximab (SAR) is monoclonal antibody (mAb).
Locations (2)
Massachusetts General Hospital, Renal Associates Clinic
Boston, Massachusetts, United States
Columbia University Irving Medical Center
New York, New York, United States