Novel Treatments in Improving Renal Outcomes in Light Chain Cast Nephropathy
- Conditions
- Multiple MyelomaLight Chain NephropathyAcute Kidney Injury
- Interventions
- Procedure: Plasma exchange
- Registration Number
- NCT06483139
- Lead Sponsor
- Brigham and Women's Hospital
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients treated with plasma exchange Plasma exchange Treated with plasma exchange ithin 30 days of diagnosis of light chain cast nephropathy Patients treated with daratumumab Daratumumab Patients treated with daratumumab within 30 days of diagnosis of light chain cast nephropathy
- Primary Outcome Measures
Name Time Method The primary composite outcome is the rate of survival with renal recovery within 90 days from the diagnosis of light chain cast nephropathy. 90 days 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.
- Secondary Outcome Measures
Name Time Method The proportion of patients with Receipt of RRT within 30 days, 60 days, and 90 days following diagnosis of light chain cast nephropathy 30, 60, 90 days The proportion of patients with Receipt of RRT within 30 days, 60 days, and 90 days following diagnsosis of LCCN
The proportion of patients with Progressive AKI 30, 60, 90 days 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.
Survival to hospital discharge 30 days Survival to hospital discharge and KRT-independent among patients admitted within 30 days of the diagnosis of light chain cast nephropathy.
Kidney recovery 30 (+/-15), 60 (+/-15), 90 (+/-30) days, and 180 days (+/-60 days) 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.
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. 90, 180, 360 days At day 90, 180, 360, with day 0 defined as date of LCCN diagnosis
Adverse events 60 days Infection, re-hospitalization, transfusion reactions, bleeding diatheses.
Renal function (SCr) at hospital discharge 30 days 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 to first renal recovery 180 days 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
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States