The Effect of Daratumumab in Patients with Monoclonal Gammopathy of Renal Significance (MGRS) in Finland

Launched by HELSINKI UNIVERSITY CENTRAL HOSPITAL · Mar 17, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating whether the drug daratumumab can help treat certain kidney diseases related to a condition called monoclonal gammopathy of renal significance (MGRS). These diseases can lead to kidney failure and are different from a specific type of amyloidosis. The study aims to find out if daratumumab can improve kidney function, reduce protein in urine, and positively impact patients’ overall quality of life. Researchers will also look at the drug's safety and any side effects that participants may experience.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of MGRS from a kidney biopsy taken within the last three months. They should have specific levels of protein in their urine or a certain level of kidney function. However, people with certain types of cancers, active infections like HIV or hepatitis, or who are pregnant or breastfeeding cannot participate. If someone joins the study, they can expect regular check-ups to monitor their health and how well the treatment is working. Overall, this trial is an important step in finding new ways to help patients with MGRS manage their kidney health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males or females ≥ 18 years of age
• • 2. Subject has provided informed consent prior to initiation of the study or subject's legally acceptable representative has provided informed consent prior to the study when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
• • 3. Renal biopsy confirmed MGRS-disease
• • Renal biopsy must not be older than 3 months before informed consent. However, if renal biopsy is older than 3 mo and the study team is convinced that major histological changes have not occurred, a biopsy older than that can exceptionally be accepted.
• • Renal transplant patients are allowed
• • 4. Amount of proteinuria ≥ 500 mg/24 h OR eGFR ≥ 20 ml/min prior to the study
• • 5. Previous anticlonal treatment is allowed if deemed ineffective
• Exclusion Criteria:
• • 1. Myeloma or systemic AL amyloidosis (smoldering myeloma sized plasma cell clone is allowed when in association with a documented MGRS condition and AHL amyloidosis and AH amyloidosis are included)
• • 2. Cancer that requires treatment,
• • 3. MGRS related to B-cell malignant disorders,
• • 4. Known HIV infection, active hepatitis C infection (subjects with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (subjects with hepatitis B surface antigen or core antibody that achieve sustained virologic response (PCR negativity in HBVNh) with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study),
• • 5. Pregnancy or breastfeeding,
• • 6. Cyclophosphamide within 6 months of enrollment, or oral high-dose prednisone or equivalent within 6 weeks of enrollment;
• • prednisone or its equivalent at a dosage of ≤10 mg daily for a condition unrelated to MGRS (e.g. asthma or gout) allowed.
• • mycophenolate mofetil (MMF), calcineurin inhibitors (CNI) or azathioprine treated patients are eligible if proteinuria is not improving or if kidney function is declining despite treatment with these medications. Once therapy with daratumumab started, these medications need to be discontinued unless they are used as immunosuppressive medication due to renal transplantation.
• • 7. In patients who previously received rituximab, reconstitution of B cells (CD19 normalized, Ly-B-CD19 lab.code 8329) required.
• • 8. Inability to use daratumumab and to comply with the study protocol as assessed by treating nephrologist and/or hematologist (e.g. severe psychiatric illness, severe lung disease, known allergy to daratumumab)