An observational study in Multiple Myeloma, Light Chain Nephropathy and Acute Kidney Injury, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Brigham and Women's Hospital · Observational
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.
Objective 1:
We will collect data from patients treated with plasma exchange from major centers across the United States to investigate whether plasma exchange improves renal outcomes.
Specifically, we will collect data on at least 150 patients treated with plasma exchange along with 300 control patients not treated with plasma exchange.
Objective 2:
We will compare renal outcomes among patients with light chain cast nephropathy and AKI treated with plasma exchange (n=150) versus daratumumab based regimen (eg Dara-CyborD) (n=150) versus other novel regimens (e.g., CyborD or another non-daratumumab-based regimen) (n=150). We will examine whether patients who receive dara-based regimens are more likely to have renal recovery compared to patients who do not receive dara-based regimens and to patients who receive plasma exchange. Given the infrequency with which plasma exchange is performed on a single-center level, we will compare outcomes among patients treated with plasma exchange, utilizing data from the multicenter study to those patients who were treated with daratumumab-based regimens without plasma exchange versus non- daratumumab-based regimen.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 549 is above the median of 140 across 468 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with multiple myeloma and clinically-suspected or biopsy-proven light chain cast nephropathy
Inclusion Criteria for Plasma Exchange-Treated Patients:
Inclusion Criteria for Control Patients:
Exclusion Criteria for Both Plasma Exchange-Treated Patients and Control Patients:
Treated with plasma exchange ithin 30 days of diagnosis of light chain cast nephropathy
Procedure: Plasma exchange
Patients not treated with plasma exchange within 30 days of diagnosis of light chain cast nephropathy
Patients treated with daratumumab within 30 days of diagnosis of light chain cast nephropathy
Drug: Daratumumab
Patients treated with daratumumab within 30 days of diagnosis of light chain cast nephropathy
Patients treated with plasma exchange within 30 days of diagnosis of light chain cast nephropathy Patients not treated with daratumumab within 30 days of diagnosis of light chain cast nephropathy
Patients treated with daratumumab within 30 days of diagnosis of light chain cast nephropathy
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.
Time frame: 90 days
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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 90, 180, 360 days
Adverse events
Infection, re-hospitalization, transfusion reactions, bleeding diatheses.
Time frame: 60 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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