Biomarkers of AKI in Patients Receiving Daratumumab

NCT06549634 | Completed FDA Drug

• 1 other identifier: 23-270
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Acute Kidney Injury; Multiple Myeloma; Light Chain Nephropathy

Outcome Measures

Primary Outcomes (1)

• Plasma and Urine Biomarkers

  The primary outcome(s) will be changes in plasma suPAR and urinary levels of DKK3 between treatment initiation of daratumumab (day 0, or up to 7 days prior) and day +30 (+/-7 days) from the time of treatment initiation.

  30 days

Study Arms (1)

Patients with multiple myeloma

Patients with multiple myeloma being newly initiated on daratumumab

Drug: Daratumumab

Interventions

Daratumumab DRUG

Daratumumab is not being administered as part of the study. Patients will receive daratumumab as part of their clinical care, and blood and urine will be collected in order to measure biomarkers pre- and post-daratumumab administration

Patients with multiple myeloma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with multiple myeloma

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Janssen Pharmaceuticals: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

10mL urine 5mL EDTA-plasma 5 mL serum Collections on day 0 and day 30

MeSH Terms

Conditions

Acute Kidney Injury; Multiple Myeloma

Interventions

daratumumab

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician, Director of Onconephrology

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: September 1, 2024
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)