Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Columbia University
Study ID
NCT04614558
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Monoclonal Gammopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Isatuximab — DRUG
    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).

Study Details

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'.

Key Dates

Start date
Jun 8, 2021
Status verified
Jun 2025
Primary completion
Apr 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Isatuximab for MGRS
    Subjects will receive Isatuximab for 6 months and will be followed for an additional one year post therapy for outcome follow-up.

Primary Outcome Measure

Overall Renal Response Rate [ Time Frame: Up to 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital, Renal Associates ClinicBostonMassachusetts02114
Meghan Sise, MD
[email protected]
Meghan Sise, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical CenterNew YorkNew York10032
Research Nurse Navigator
[email protected]
212-342-5162
Divaya Bhutani, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital, Renal Associates Clinic· Boston, MAColumbia University Irving Medical Center· New York, NY

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