Understanding kidney injury biomarkers in multiple myeloma patients receiving Daratumumab

Biomarkers of AKI in Patients With Multiple Myeloma Receiving Daratumumab: A Pilot Study

This study is testing if certain urine and blood markers can help find early signs of kidney injury in people with multiple myeloma who are starting treatment with Daratumumab.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Brigham and Women's Hospital (other)
• Drugs / interventions: daratumumab, chemotherapy, radiation
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06549634 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate changes in urinary and blood biomarkers related to acute kidney injury (AKI) in patients newly diagnosed with multiple myeloma who are being treated with Daratumumab. Participants will provide urine and blood samples before starting treatment and 30 days after to measure these biomarkers. The study seeks to determine if these biomarkers can help in the early detection and prevention of AKI, which is a significant concern in this patient population. The research focuses on novel markers that have shown promise in other clinical settings but have not been previously studied in multiple myeloma patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a new diagnosis of multiple myeloma who are at risk for AKI and receiving Daratumumab.

Not a fit: Patients with end-stage renal disease or those who have previously received systemic treatment for multiple myeloma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved early detection and prevention strategies for acute kidney injury in multiple myeloma patients.

How similar studies have performed: Other studies have shown success with similar biomarker approaches in different clinical settings, suggesting potential for this study's methodology.

Eligibility 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)

Where this trial is running

Boston, Massachusetts

• Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Study coordinator: Shruti Gupta, MD, MPH

Conditions: Acute Kidney Injury, Multiple Myeloma, Light Chain Nephropathy