Plasma and Urinary Biomarkers of Kidney Injury in Daratumumab-Treated Multiple Myeloma Patients
This study aims to observe changes in specific plasma and urinary biomarkers in patients with multiple myeloma, from the start of daratumumab treatment to 30 days later, to understand the impact on kidney health.
Data Collection
Collected from today forward - ProspectiveUrogenital Diseases+20
+ Blood Protein Disorders
+ Cardiovascular Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: September 1, 2024
Actual date on which the first participant was enrolled.This study focuses on patients newly diagnosed with multiple myeloma, a type of cancer that affects plasma cells in the bone marrow. The research aims to find better ways to detect acute kidney injury (AKI), a common complication in these patients. Currently, doctors use a substance called serum creatinine to identify AKI, but it often shows up late, after significant damage has already occurred. This study explores the use of new markers, such as soluble urokinase-type plasminogen activator receptor (suPAR) and Dickkoph-3 (DKK3), which have shown promise in detecting AKI early in other clinical settings. The goal is to see if these markers can help predict AKI in multiple myeloma patients receiving a treatment called daratumumab. In this observational study, participants with newly-diagnosed multiple myeloma who are at risk for AKI will receive daratumumab treatment. The study will measure changes in the levels of suPAR in the blood and DKK3 in the urine. These measurements will be taken from the start of the treatment (day 0, or up to 7 days prior) and again 30 days later (plus or minus 7 days). The main outcome of the study is to see if there is at least a 10% decline in these biomarkers after the treatment with daratumumab. This could potentially indicate a lower risk of developing AKI.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Patients must be ≥ 18 years of age * Patients can be on a clinical trial * Patients must have had a confirmed new diagnosis of MM following revised IMWG criteria 1. New diagnosis of systemic multiple myeloma defined as no documented history of prior multiple myeloma. 2. Further, no prior systemic treatment with anti-myeloma agent is permitted with the exception of corticosteroids for no more than 4 weeks. 3. Prior history of receiving radiation therapy for the treatment of plasmacytoma or lytic lesions, is permitted on the study. * Patients receiving SC daratumumab * Patients must be able to sign the informed consent * Patients must be at risk for AKI and meet at least two of the three following criteria: age ≥65; baseline eGFR \<60; or use of NSAIDs (not including aspirin), bisphosphonates, intravenous contrast, diuretics, or RAS inhibitors in the 14 days preceding treatment initiation Exclusion Criteria: * End stage renal disease (e.g, on long-term dialysis or with a kidney transplant and on long-term dialysis) at the time of starting daratumumab * Acute kidney injury defined as a ≥1.5-fold rise in baseline SCr, where baseline SCr is the lowest SCr in the 365 days preceding receipt of daratumumab, or with AKI on RRT * Previous exposure to daratumumab or other anti-CD38 therapy * Patients receiving intravenous daratumumab * Exposure to concomitant chemotherapy which could be perceived as nephrotoxic within 30 days of receipt of daratumumab (e.g., cisplatin, mTOR inhibitors) * Moribund patients (e.g., those expected to die in the next 30 days from the time of screening)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location