NCT06483139

Novel Treatments in Improving Renal Outcomes in Light Chain Cast Nephropathy

The Effect of Novel Treatments in Improving Renal Outcomes Among Patients With Light Chain Cast Nephropathy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Multiple Myeloma
• Light Chain Nephropathy
• Acute Kidney Injury

Interventions

Type	Name	Description
PROCEDURE	Plasma exchange	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
DRUG	Daratumumab	Patients treated with daratumumab within 30 days of diagnosis of light chain cast nephropathy

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-07-03
• Last updated: 2025-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study