Effect of Daratumumab on Kidney Diseases Related to Monoclonal Gammopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy of daratumumab in treating kidney diseases categorized under monoclonal gammopathy of renal significance (MGRS) in Finland. The study aims to assess the drug's impact on renal function, proteinuria levels, and hematological endpoints, including minimal residual disease and free light chain levels. Additionally, it evaluates changes in patients' quality of life and the activation of the complement system. The trial will also monitor the rate of hematological remission and any adverse events associated with daratumumab.

Why it matters

Who can join: the full rules

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)

Where it's running

• Helsinki University Hospital
  Helsinki, Finland Recruiting

Study contacts

• Study coordinator: Minna Seppälä, MD
• Email: minna.seppala@hus.fi
• Phone: +358 50 427 1087

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.