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
Brigham and Women's Hospital
450 participants
Jun 1, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- 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
- 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 Criteria9
- 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
Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06483139