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Plasma and Urinary Biomarkers of Kidney Injury in Daratumumab-Treated Multiple Myeloma Patients

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Study Aim

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.

What is being collected

Data Collection

Collected from today forward - Prospective
No DNA Sample
Who is being recruted

Urogenital Diseases+20

+ Blood Protein Disorders

+ Cardiovascular Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2024
See protocol details

Summary

Principal SponsorBrigham and Women's Hospital
Study ContactShruti Gupta, MD, MPHMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleBiomarkers of AKI in Patients With Multiple Myeloma Receiving Daratumumab: A Pilot Study
Principal SponsorBrigham and Women's Hospital
Study ContactShruti Gupta, MD, MPHMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Urogenital DiseasesBlood Protein DisordersCardiovascular DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersKidney DiseasesLymphoproliferative DisordersMultiple MyelomaNeoplasmsNeoplasms by Histologic TypeParaproteinemiasUrologic DiseasesVascular DiseasesHemostatic DisordersRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesNeoplasms, Plasma CellAcute Kidney Injury

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

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

Recruiting

Brigham and Women's Hospital

Boston, United StatesOpen Brigham and Women's Hospital in Google Maps
Recruiting
One Study Center
Plasma and Urinary Biomarkers of Kidney Injury in Daratumumab-Treated Multiple Myeloma Patients | PatLynk