Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance
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|ClinicalTrials.gov Identifier: NCT04614558|
Recruitment Status : Not yet recruiting
First Posted : November 4, 2020
Last Update Posted : July 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Monoclonal Gammopathy||Drug: Isatuximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The study will be a single arm, prospective, multi-center, phase II, open- label study including 27 subjects in total. The study will consist of a screening phase, treatment phase, post-treatment observation phase and follow-up phase|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Multicenter, Phase II, Open-Label Trial to Evaluate Efficacy of Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance|
|Estimated Study Start Date :||November 2021|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||June 2023|
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.
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).
Other Name: Sarclisa
- Overall Renal Response Rate [ Time Frame: Up to 6 months ]Renal response defined as a decrease in 24-hour proteinuria by >50% at any point post therapy.
- Number of Adverse Events [ Time Frame: Up to 12 months ]The number of adverse events recorded for participants using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- Percentage of Participants with Immunoglobulin Gene Mutations [ Time Frame: Baseline, up to 4 weeks prior to treatment ]The percentage of participants with immunoglobulin gene mutations as determined by next generation sequencing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04614558
|Contact: Research Nurse Navigatorfirstname.lastname@example.org|
|United States, New York|
|Columbia University Irving Medical Center|
|New York, New York, United States, 10032|
|Contact: Research Nurse Navigator 212-342-5162 email@example.com|
|Principal Investigator: Divaya Bhutani, MD|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Jonathan Hogan, MD 215-662-2638 Jonathan.Hogan2@pennmedicine.upenn.edu|
|Principal Investigator: Jonathan Hogan, MD|
|Principal Investigator:||Divaya Bhutani, MD||Assistant Professor of Medicine at the Columbia University|