Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance
ConditionMonoclonal Gammopathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About this trial
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'.
Eligibility criteria
Qualifiers
Proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID)
C3 glomerulopathy associated with monoclonal gammopathy
Non-Amyloid Fibrillary Glomerulonephritis
Light chain Proximal Tubulopathy
Disqualifiers
Participants who have had chemotherapy based therapy within 12 weeks or Rituximab based therapy within prior 24 weeks prior to starting the cycle 1 Day 1 of trial therapy
Participants who are receiving any other investigational agents concurrently.
History of severe allergic reactions or anaphylaxis attributed to compounds of similar chemical or biologic composition to Isatuximab.
Diagnosis of Multiple Myeloma or High risk smoldering Multiple Myeloma or a B cell lymphoma meeting criteria for therapy.
Trial design
Treatments tested in this trial
- Isatuximab
Treatment groups
27 Participants
are divided into 1 treatment groupSponsors and collaborators
Columbia University
Lead sponsor
Genzyme, a Sanofi Company
Collaborator
Source ClinicalTrials.gov