Can a multiple myeloma drug shield the kidneys in MGRS?

NCT ID NCT04614558

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether isatuximab, an antibody drug already approved for multiple myeloma, can improve kidney function in people with monoclonal gammopathy of renal significance (MGRS). MGRS is a condition where abnormal proteins damage the kidneys. Participants receive isatuximab by IV for six months, and researchers measure whether protein in the urine drops by more than half, a sign of kidney improvement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
isatuximab (Sarclisa), an antibody drug given by IV
What this could lead to
If it works, this could point toward a new treatment option to protect kidney function in people with MGRS.
What could go wrong
This is a small, early-phase trial with only 12 participants and no comparison group. Isatuximab is not yet approved for MGRS, and its effectiveness and safety for this condition are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

12 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 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. 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: Leukocytes ≥3,000/microliters (mcL) 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. Exclusion Criteria: 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Massachusetts General Hospital, Renal Associates Clinic

    Boston, Massachusetts, 02114, United States

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