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

NCT06889948 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-03-21

No results posted yet for this study

Summary

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

Interventions

DRUG

Daratumumab

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

Sponsors & Collaborators

  • Janssen, L.P. - Investigator Initiated Studies Program

    collaborator UNKNOWN

  • Helsinki University Central Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-19
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Finland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06889948 on ClinicalTrials.gov