Novel Treatments in Improving Renal Outcomes in Light Chain Cast Nephropathy
NCT Number: NCT06483139
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Multiple Myeloma|Light Chain Nephropathy|Acute Kidney Injury
Interventions: PROCEDURE: Plasma exchange|DRUG: Daratumumab
Sponsor: Brigham and Women's Hospital
Collaborators: Janssen, LP|Baystate Health|Boston Medical Center|Dana-Farber Cancer Institute|Massachusetts General Hospital|Mayo Clinic|M.D. Anderson Cancer Center|Medical University of South Carolina|H. Lee Moffitt Cancer Center and Research Institute|Icahn School of Medicine at Mount Sinai|Northwell Health|Ochsner Health System|Ohio State University|Stanford University|Texas Medical Center|Thomas Jefferson University|University of Alabama at Birmingham|University of California, Los Angeles|University of Chicago|University of Colorado Health|University of Minnesota|University of New Mexico|University of Pennsylvania|University of Pittsburgh|University of Virginia|University of Washington
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2026-06-01
Locations: Brigham and Women's Hospital, Boston, Massachusetts, 02130, United States

Summary:
Objective 1: To test whether treatment with plasma exchange improves renal recovery in patients with light chain cast nephropathy Objective 2: To compare renal outcomes among patients treated with plasma exchange versus daratumumab-based regimens versus non-daratumumab based-regimens.

Primary Outcome Measures: The primary composite outcome is the rate of survival with renal recovery within 90 days from the diagnosis of light chain cast nephropathy., To meet the primary outcome, patients must be alive, not RRT-dependent (e.g., were never on dialysis/no longer on dialysis), and have a decline of at least one stage of AKI severity compared to their highest AKI stage achieved at the time of light chain cast nephropathy-associated AKI. AKI staging will be based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria, where stage 1 is a 1.5-1.9-fold rise in SCr from baseline; stage 2 is a 2-2.9-fold rise from baseline; and stage 3 is a 3-fold rise in SCr from baseline or initiation of RRT. Baseline SCr is defined as the lowest SCr in the 365 days preceding the diagnosis of light chain cast nephropathy., 90 days
Secondary Outcome Measures: The proportion of patients with Receipt of RRT within 30 days, 60 days, and 90 days following diagnosis of light chain cast nephropathy, The proportion of patients with Receipt of RRT within 30 days, 60 days, and 90 days following diagnsosis of LCCN, 30, 60, 90 days|The proportion of patients with Progressive AKI, Defined as progression from existing AKI (stage 2) to a higher stage (stage 3 or receipt of RRT) within 30, 60, and 90 days following diagnosis of light chain cast nephropathy. AKI staging at each of these time points will be defined based on KDIGO criteria outlined above., 30, 60, 90 days|Survival to hospital discharge, Survival to hospital discharge and KRT-independent among patients admitted within 30 days of the diagnosis of light chain cast nephropathy., 30 days|Renal function (SCr) at hospital discharge, Renal function (SCr) at hospital discharge (% increase compared to baseline) among patients who are admitted within 30 days of their diagnosis of light chain cast nephropathy, 30 days|Time to first renal recovery, Renal recovery will be defined as not RRT-dependent, and with nadir SCr returning to \<50% of baseline. This will be assessed within 180 days following the diagnosis of light chain cast nephropathy, 180 days|Kidney recovery, at 30 (+/-15), 60 (+/-15), 90 (+/-30) days, and 180 days (+/-60 days) following the diagnosis of light chain cast nephropathy, , defined as survival, KRT-independent, and with SCr \<1.5-fold baseline at each of the above time points., 30 (+/-15), 60 (+/-15), 90 (+/-30) days, and 180 days (+/-60 days)|Overall survival at day 90, 180, 360, with day 0 defined as date of LCCN diagnosis. Patients who die within 48 hours of the diagnosis will be excluded., At day 90, 180, 360, with day 0 defined as date of LCCN diagnosis, 90, 180, 360 days|Adverse events, Infection, re-hospitalization, transfusion reactions, bleeding diatheses., 60 days