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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
All patients will receive either fixed-dose daratumumab as a single agent therapy or fixed-dose daratumumab combined with stem cell transplantation.
Helsinki University Hospital
Helsinki, Finland
RECRUITINGRate of complete renal remission or partial renal remission and proteinuria and eGFR at EOT.
Complete renal remission (proteinuria \<500 mg/d and \<15% decline in baseline eGFR) Partial renal remission (\>50% reduction in 24-h proteinuria and \< 30% decline in eGFR)
Time frame: Through study completion, an average of 12 to 18 months
Rate of complete renal remission or partial renal remission and proteinuria and eGFR after 6 cycles of daratumumab.
Complete renal remission (proteinuria \<500 mg/d and \<15% decline in baseline eGFR) Partial renal remission (\>50% reduction in 24-h proteinuria and \< 30% decline in eGFR)
Time frame: At the end of daratumumab treatment cycle 6 (each cycle is 28 days)
Rate of negativity of bone marrow minimal residual disease (MRD) after 6 and 12 cycles of daratumumab.
Time frame: At the end of cycle 6 (each cycle is 28 days) and through study completion, an average of 12 to 18 months
Number of patients with complement dysregulation-mediated renal damage caused by paraprotein.
Time frame: Through study completion, an average of 12 to 18 months
Number of patients in end-stage renal disease or with eGFR decline > 50 %.
Time frame: Through study completion, an average of 12 to 18 months
Number of patients with proteinuria decline < 25 %.
Time frame: Through study completion, an average of 12 to 18 months
Number of patients with complete or partial or very good partial hematological remission
Time frame: Through study completion, an average of 12 to 18 months
Number of patients with serious adverse events (SAE)
Time frame: Through study completion, an average of 12 to 18 months
Number of patients with significant adverse events (AE)
Time frame: Through study completion, an average of 12 to 18 months
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