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E-Poster Submission Deadline
Please prepare and upload your E-Poster no later than March 14, 2026 11.59PM CET. After this date, you will no longer be able to prepare and upload your E-poster and it will not be displayed and accessible on the congress website.
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Abstract titles should be brief and reflect the content of the abstract.
Kidney diseases caused by monoclonal gammopathy not fulfilling criteria of overt hematological malignancy are grouped under the term monoclonal gammopathy of renal significance (MGRS). Kidney biopsy is mandatory to make the diagnosis.
There is paucity of data on the treatment of MGRS, but it is usually directed at the underlying B-cell or plasma cell clones. No formal treatment guidelines exist in other than amyloid light-chain (AL) amyloidosis. Renal response is most often evaluated based on changes in renal function and proteinuria, hematological response usually by the changes in paraprotein levels or rarely by bone marrow minimal residual disease (MRD).
Daratumumab, a monoclonal CD38 antibody, has been prospectively investigated in only one study comprising 12 patients with proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID) and C3 glomerulopathy (C3G) showing promising results on the efficacy and tolerability after treatment of six months.
Our aim is to prospectively investigate daratumumab either alone or in combination with autologous stem cell transplantation (ASCT) in the treatment of kidney and hematological conditions in plasma cell derived MGRS diseases as well as range of methods to establish the depth of treatment response.
Patients with MGRS diagnoses from kidney biopsy are included. AL amyloidosis is excluded as it has an established treatment. The treatment scheme is presented in Figure 1. The main inclusion and exclusion criteria are presented in Table 1. Renal transplant patients are allowed.
Primary endpoints: Rate of complete renal remission (proteinuria <500 mg/d and <15% decline in baseline eGFR), rate of partial renal remission (>50% reduction in 24-h proteinuria and < 30% decline in eGFR) and the amount of proteinuria and eGFR compared to baseline values after 12 cycles of daratumumab or after the last cycle.
Secondary endpoints: The same as in primary endpoints after 6 cycles of daratumumab, rate of bone marrow MRD-negativity after 6 and 12 cycles of daratumumab, changes in quality of life, number of patients with complement dysregulation-mediated renal damage caused by paraprotein, number of patients in end-stage renal disease or with eGFR decline > 50 % from baseline to end of study (EOT), number of patients with proteinuria decline < 25 % from baseline to EOT, number of patients with complete or partial or very good partial hematological remission at EOT, number of patients with serious adverse events (SAE) or adverse events (AE) during the study.
Complement profiles are investigated also during the study. MRD in bone marrow was assessed according to the next-generation flow cytometry (NGF).
Sample size estimation is based on the accuracy of confidence interval for remission parameter. If 30% of patients are in complete remission when observed, and altogether 30 patients are recruited for the study, 95% confidence interval will be from 14.7% to 49.4%. Then it can be claimed that remission proportion is at least 14% with the treatment.
The study is ongoing and 12 patients have signed the informed consent. The majority are male (75 %). The most usual kidney and hematological diagnoses are PGNMID (50 %), and smoldering myeloma (42 %), respectively. Two patients have undergone ASCT and one more is going to. All ASCT patients had light chain deposition disease (LCDD).
The study will provide important data on the effectiveness of daratumumab either alone or in combination with ASCT in the treatment of both kidney and hematological conditions on various MGRS diseases.
