Actively Recruiting
The Effect of Daratumumab in Patients with Monoclonal Gammopathy of Renal Significance (MGRS) in Finland
Led by Helsinki University Central Hospital · Updated on 2025-03-21
30
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
Sponsors
H
Helsinki University Central Hospital
Lead Sponsor
J
Janssen, L.P. - Investigator Initiated Studies Program
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if drug daratumumab works to treat kidney diseases other than AL-amyloidosis that fall under the category of monoclonal gammopathy of renal significance (MGRS). The main questions it aims to answer are: Does daratumumab have an effect on the patients' renal function or the amount of proteinuria? Does daratumumab have an effect on the hematological endpoints evaluated by minimal residual disease (MRD) and the difference between involved and uninvolved free light chain (dFLC)? Also changes in quality of life (according to EORTC QLQ-C30) and mechanism of complement system activation are evaluated. The number of patiets with partial or very good partial hematological remission and the number of patients with adverse events related to daratumumab are also recorded.
CONDITIONS
Official Title
The Effect of Daratumumab in Patients with Monoclonal Gammopathy of Renal Significance (MGRS) in Finland
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Provided informed consent or legally acceptable representative consent
- Renal biopsy confirmed MGRS disease within 3 months prior to consent (older biopsy allowed if no major changes expected)
- Renal transplant patients allowed
- Proteinuria of at least 500 mg/24 h or eGFR of at least 20 ml/min prior to study
- Previous anticlonal treatment allowed if ineffective
You will not qualify if you...
- Presence of myeloma or systemic AL amyloidosis (smoldering myeloma clone allowed if associated with documented MGRS)
- Active cancer requiring treatment
- MGRS related to B-cell malignant disorders
- Known HIV infection, active hepatitis C infection (except if sustained virologic response achieved), or hepatitis B infection without sustained virologic response
- Pregnancy or breastfeeding
- Cyclophosphamide use within 6 months or oral high-dose prednisone or equivalent within 6 weeks (low-dose prednisone for unrelated conditions allowed)
- Patients treated with mycophenolate mofetil, calcineurin inhibitors, or azathioprine only if proteinuria or kidney function is not improving; must discontinue these if starting daratumumab unless used for renal transplant immunosuppression
- Rituximab-treated patients must have normalized B cell count (CD19)
- Inability to use daratumumab or comply with study protocol due to severe psychiatric illness, severe lung disease, or known daratumumab allergy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Helsinki University Hospital
Helsinki, Finland
Actively Recruiting
Research Team
M
Minna Seppälä, MD
CONTACT
K
Kati Kaartinen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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