Status:
RECRUITING
Biomarkers of AKI in Patients Receiving Daratumumab
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Janssen Pharmaceuticals
Conditions:
Acute Kidney Injury
Multiple Myeloma
Eligibility:
All Genders
18+ years
Brief Summary
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 an...
Detailed Description
Serum creatinine is an insensitive marker of AKI, often rising late and after significant injury has already occurred. A number of novel markers have recently been shown to have utility in the early d...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
September 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06549634
Start Date
September 1 2024
End Date
October 1 2026
Last Update
February 5 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115