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

Sponsor
Helsinki University Central Hospital
Study ID
NCT06889948
Phase
PHASE2
Status
Recruiting
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Conditions

  • Glomerulonephritis
  • Kidney Failure
  • Paraproteinemias

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    All patients will receive either fixed-dose daratumumab as a single agent therapy or fixed-dose daratumumab combined with stem cell transplantation.

Study Details

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.

Key Dates

Start date
Jan 19, 2024
Status verified
Mar 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Daratumumab as a single agent therapy
    Daratumumab
  • Active Comparator: Daratumumab combined with stem cell transplantation
    Daratumumab in combination with stem cell transplantation

Primary Outcome Measure

Rate of complete renal remission or partial renal remission and proteinuria and eGFR at EOT. [ Time Frame: Through study completion, an average of 12 to 18 months ]

Central Contacts

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