- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04614558
Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance
A Single Arm, Multicenter, Phase II, Open-Label Trial to Evaluate Efficacy of Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Research Nurse Navigator
- Phone Number: 212-342-5162
- Email: cancerclinicaltrials@cumc.columbia.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital, Renal Associates Clinic
-
Contact:
- Meghan Sise, MD
- Email: msise@partners.org
-
Principal Investigator:
- Meghan Sise, MD
-
-
New York
-
New York, New York, United States, 10032
- Recruiting
- Columbia University Irving Medical Center
-
Principal Investigator:
- Divaya Bhutani, MD
-
Contact:
- Research Nurse Navigator
- Phone Number: 212-342-5162
- Email: cancerclinicaltrials@cumc.columbia.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Renal biopsy proven diagnosis of an MGRS disorder including the following:
- Proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID)
- C3 glomerulopathy associated with monoclonal gammopathy
- Non-Amyloid Fibrillary Glomerulonephritis
- Light chain Proximal Tubulopathy
- Immunotactoid Glomerulopathy
A concurrent diagnosis of Monoclonal gammopathy (with +ve Serum and/or Urine protein electrophoresis or Bone marrow biopsy) is required in patients with C3 glomerulopathy but not for other disorders. Patients with concurrent MGUS, non-high risk smoldering myeloma are eligible for enrollment.
- Measurable Proteinuria ≥1gram over 24 hours.
- Prior Therapy: Newly diagnosed as well as patients with previous therapy but persistent renal dysfunction and persistent proteinuria ≥1gram over 24 hours are eligible for enrollment. Patients who received a prior cluster of differentiation 38 (CD38) antibody therapy are not eligible for study. In patients who have received prior therapy a wash out period of 12 weeks for chemotherapy based therapies and 24 weeks for Rituximab based therapies is required between completion of prior therapy and cycle 1 Day1 of study therapy.
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Life expectancy of greater than 6 months
- Participants must have normal organ and marrow function as defined below:
Leukocytes ≥3,000/microliters (mcL)
- absolute neutrophil count ≥1,500/mcL
- platelets ≥100,000/mcL
- total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (SGOT)/alanine transaminase (ALT)(SGPT) ≤2.5 × institutional upper limit of normal
- Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2.
Exclusion Criteria:
- 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.
- Renal Biopsy showing the coexistence of other significant diagnosis e.g. diabetic nephropathy.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and Lactating women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Isatuximab.
- HIV-positive Participants are ineligible because of increased risk of lethal infections when treated with immunosuppressive therapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 12 months
|
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.
|
Baseline, up to 4 weeks prior to treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Divaya Bhutani, MD, Assistant Professor of Medicine at the Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAT0761
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Monoclonal Gammopathy
-
RxCelerate LtdRxCelerate LimitedUnknownMonoclonal Gammopathy of Unknown SignificanceUnited Kingdom
-
Emory UniversityThe Leukemia and Lymphoma SocietyRecruitingWaldenstrom Macroglobulinemia | Light Chain Deposition Disease | IgA Monoclonal Gammopathy | IgG Monoclonal Gammopathy | IgM Monoclonal Gammopathy | Monoclonal Gammopathy | Smoldering Waldenstrom Macroglobulinemia | Gammopathy, Monoclonal | Gammopathy IggUnited States
-
Rennes University HospitalCompletedMyeloma | Monoclonal Gammopathy | Monoclonal Gammopathy of Undetermined SignificationFrance
-
University of Milano BicoccaCompletedMonoclonal Gammopathy of Renal SignificanceItaly
-
Dartmouth-Hitchcock Medical CenterCelgene CorporationTerminatedNeuropathy | Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS)United States
-
Academia Nacional de MedicinaUnknownMonoclonal Gammopathy of Renal SignificanceArgentina
-
UMC UtrechtBeiGeneNot yet recruitingMonoclonal Gammopathy of Uncertain SignificanceNetherlands
-
University of MiamiWithdrawnObesity | Overweight | Monoclonal Gammopathies
-
Oxford University Hospitals NHS TrustRecruiting
-
Regeneron PharmaceuticalsNot yet recruitingMonoclonal Gammopathy of Undetermined Significance (MGUS) | Smoldering Multiple Myeloma (SMM)
Clinical Trials on Isatuximab
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingMultiple Myeloma | Monoclonal Gammopathy of Undetermined Significance | Cryoglobulinemic Vasculitis
-
Thomas Martin, MDWithdrawnRefractory Multiple Myeloma | Relapsed Multiple Myeloma
-
Divaya BhutaniGenzyme, a Sanofi CompanyRecruitingIsatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and LymphomaLymphoma | Multiple Myeloma | Non-Hodgkin Lymphoma | Relapsed Hodgkin's Disease, AdultUnited States
-
Firas El Chaer, MDRecruitingHematologic Malignancy | Platelet RefractorinessUnited States
-
Memorial Sloan Kettering Cancer CenterSanofiRecruitingBlood Cancer | Refractory Immune CytopeniasUnited States
-
Assistance Publique - Hôpitaux de ParisNot yet recruiting
-
SanofiTerminatedWarm Autoimmune Hemolytic Anemia (wAIHA)United Kingdom, Belgium, Netherlands, France, United States, Germany, Hungary, Italy
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingSmoldering Plasma Cell MyelomaUnited States
-
Karolinska InstitutetSanofi; XNK Therapeutics AB, SwedenRecruiting
-
SanofiCompleted