Biomarkers of AKI in Patients with Multiple Myeloma Receiving Daratumumab: a Pilot Study ACUTE KIDNEY INJURY IN MYELOMA PATIENTS

What's the purpose of this trial?

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. 

This trial is currently open and accepting patients.

What will happen during the trial?

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.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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)

Additional Trial Information

Enrollment: 20 patients (estimated)

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Trial Locations

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Massachusetts

Brigham and Women's Hospital

Boston, MA

Open and Accepting
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