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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Isatuximab
DrugIsatuximab 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).
Treatment groups
27 Participants
are divided into 1 treatment groupGroup A: Isatuximab for MGRSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Renal Response Rate
Renal response defined as a decrease in 24-hour proteinuria by \>50% at any point post therapy.
Time frame
Up to 6 monthsSecondary outcomes
1
Number of Adverse Events
The number of adverse events recorded for participants using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
Up to 12 months2
Percentage of Participants with Immunoglobulin Gene Mutations
The percentage of participants with immunoglobulin gene mutations as determined by next generation sequencing.
Time frame
Baseline, up to 4 weeks prior to treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
Genzyme, a Sanofi Company
Collaborator
Source ClinicalTrials.gov