RECRUITING

Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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'.

Official Title

A Single Arm, Multicenter, Phase II, Open-Label Trial to Evaluate Efficacy of Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance

Quick Facts

Study Start:2021-06-08

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04614558

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Renal biopsy proven diagnosis of an MGRS disorder including the following: 1. Proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID) 2. C3 glomerulopathy associated with monoclonal gammopathy 3. Non-Amyloid Fibrillary Glomerulonephritis 4. Light chain Proximal Tubulopathy 5. Immunotactoid Glomerulopathy 2. Measurable Proteinuria ≥1gram over 24 hours. 3. 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. 4. Age ≥18 years. 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2. 6. Life expectancy of greater than 6 months 7. Participants must have normal organ and marrow function as defined below: 1. absolute neutrophil count ≥1,500/mcL 2. platelets ≥100,000/mcL 3. total bilirubin within normal institutional limits 4. Aspartate aminotransferase (AST) (SGOT)/alanine transaminase (ALT)(SGPT) ≤2.5 × institutional upper limit of normal 5. Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2.	1. 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 2. Participants who are receiving any other investigational agents concurrently. 3. History of severe allergic reactions or anaphylaxis attributed to compounds of similar chemical or biologic composition to Isatuximab. 4. Diagnosis of Multiple Myeloma or High risk smoldering Multiple Myeloma or a B cell lymphoma meeting criteria for therapy. 5. Renal Biopsy showing the coexistence of other significant diagnosis e.g. diabetic nephropathy. 6. 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. 7. 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. 8. HIV-positive Participants are ineligible because of increased risk of lethal infections when treated with immunosuppressive therapy.

Inclusion Criteria

Exclusion Criteria

1. Renal biopsy proven diagnosis of an MGRS disorder including the following:
1. Proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID)
2. C3 glomerulopathy associated with monoclonal gammopathy
3. Non-Amyloid Fibrillary Glomerulonephritis
4. Light chain Proximal Tubulopathy
5. Immunotactoid Glomerulopathy
2. Measurable Proteinuria ≥1gram over 24 hours.
3. 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.
4. Age ≥18 years.
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
6. Life expectancy of greater than 6 months
7. Participants must have normal organ and marrow function as defined below:
1. absolute neutrophil count ≥1,500/mcL
2. platelets ≥100,000/mcL
3. total bilirubin within normal institutional limits
4. Aspartate aminotransferase (AST) (SGOT)/alanine transaminase (ALT)(SGPT) ≤2.5 × institutional upper limit of normal
5. Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2.

1. 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
2. Participants who are receiving any other investigational agents concurrently.
3. History of severe allergic reactions or anaphylaxis attributed to compounds of similar chemical or biologic composition to Isatuximab.
4. Diagnosis of Multiple Myeloma or High risk smoldering Multiple Myeloma or a B cell lymphoma meeting criteria for therapy.
5. Renal Biopsy showing the coexistence of other significant diagnosis e.g. diabetic nephropathy.
6. 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.
7. 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.
8. HIV-positive Participants are ineligible because of increased risk of lethal infections when treated with immunosuppressive therapy.

Contacts and Locations

Study Contact

Research Nurse Navigator

CONTACT

212-342-5162

cancerclinicaltrials@cumc.columbia.edu

Principal Investigator

Divaya Bhutani, MD

PRINCIPAL_INVESTIGATOR

Assistant Professor of Medicine at the Columbia University

Study Locations (Sites)

Massachusetts General Hospital, Renal Associates Clinic

Boston, Massachusetts, 02114

United States

Columbia University Irving Medical Center

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Columbia University

Divaya Bhutani, MD, PRINCIPAL_INVESTIGATOR, Assistant Professor of Medicine at the Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-08

Study Completion Date2025-06

Study Record Updates

Study Start Date2021-06-08

Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

Monoclonal Gammopathy