NCT06549634Completed
Biomarkers of AKI in Patients Receiving Daratumumab
Biomarkers of AKI in Patients With Multiple Myeloma Receiving Daratumumab: A Pilot Study
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
The goal of this prospective observational study is to understand changes in urinary and blood biomarkers associated with acute kidney injury (AKI) in patients newly diagnosed with multiple myeloma and being treated with Daratumumab SC. The aims of the study are: To measure changes in plasma and urinary biomarkers of AKI before initiation of Daratumumab therapy and 30 days after initiation of therapy. To establish whether these biomarkers serve to aid in early detection and prevention of AKI Participants will give urine and blood samples at their normally scheduled lab appointments.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 20 (actual)
- First submitted
- 8 Aug 2024
- Start date
- 1 Sept 2024
- Primary completion date
- 15 Jan 2026
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Multiple myeloma
- NCT number
- NCT06549634
What you commit to
- Study type: Observational
- Participants enrolled: 20
- From 1 Sept 2024 to the primary completion date, 15 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
Other
- 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
- Moribund patients (e.g., those expected to die in the next 30 days from the time of screening)
Who the study is looking for
- 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
- New diagnosis of systemic multiple myeloma defined as no documented history of prior multiple myeloma.
- Further, no prior systemic treatment with anti-myeloma agent is permitted with the exception of corticosteroids for no more than 4 weeks.
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.