RECRUITING

Biomarkers of AKI in Patients Receiving Daratumumab

Conditions

Acute Kidney Injury Multiple Myeloma Light Chain Nephropathy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Biomarkers of AKI in Patients with Multiple Myeloma Receiving Daratumumab: a Pilot Study

Quick Facts

Study Start:2024-09-01

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06549634

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Study Contact

Shruti Gupta, MD, MPH

CONTACT

5712366626

sgupta21@bwh.harvard.edu

Sophia L Wells

CONTACT

330-802-5405

swells8@bwh.harvard.edu

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-01

Study Completion Date2026-10

Study Record Updates

Study Start Date2024-09-01

Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

Acute Kidney Injury
Multiple Myeloma
Light Chain Nephropathy