Status:
RECRUITING
Novel Treatments in Improving Renal Outcomes in Light Chain Cast Nephropathy
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Janssen, LP
Baystate Health
Conditions:
Multiple Myeloma
Light Chain Nephropathy
Eligibility:
All Genders
18+ years
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 pla...
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,...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Plasma Exchange-Treated Patients:
- Adult (≥18 years old)
- Either a new diagnosis of multiple myeloma confirmed by bone marrow plasmayctosis \>10% or acute relapse of multiple myeloma
- Light chain cast nephropathy, with involved light chain \>500 mg/L
- Acute kidney injury, defined as ≥1.5-fold rise in SCr from baseline (as defined in study outcomes) or the need for renal replacement therapy (RRT).
- Treated with at least 1 round of plasma exchange within 30 days of diagnosis of cast nephropathy
- Treated with plasma exchange in 2010 or later
- Inclusion Criteria for Control Patients:
- Adult (≥18 years old)
- Either a new diagnosis of multiple myeloma confirmed by bone marrow plasmayctosis \>10% or acute relapse of multiple myeloma
- Light chain cast nephropathy, with involved light chain \>500 mg/L
- Acute kidney injury, defined as ≥1.5-fold rise in SCr from baseline or the need for renal replacement therapy (RRT)
- Exclusion Criteria for Both Plasma Exchange-Treated Patients and Control Patients:
- Patients with end stage kidney disease
- Patients with amyloidosis or monoclonal immunoglobulin deposition disease
- Patients with chronic lymphocytic leukemia, plasma cell leukemia, or Waldenstrom's
- Moribund condition (e.g., patients who died within 48 hours of initiation of plasma exchange)
- Active urinary tract obstruction on renal imaging
- Patients with significant albuminuria (≥2+ on urinary dipstick or \>10% fraction on UPEP)
- Patients with other biopsy-proven causes of AKI (non-cast nephropathy lesions)
- Patients who did not receive clone-directed therapy for myeloma
- Patients who received plasma exchange \>30 days from the time of diagnosis of cast nephropathy
Exclusion
Key Trial Info
Start Date :
June 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06483139
Start Date
June 1 2024
End Date
June 1 2026
Last Update
November 19 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02130