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Completed
NCT06483139
Novel Treatments in Improving Renal Outcomes in Light Chain Cast Nephropathy
Conditions: Multiple Myeloma, Light Chain Nephropathy, Acute Kidney Injury
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 549
Sponsor: Brigham and Women's Hospital
Location: Brigham and Women's Hospital Boston Massachusetts
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 Criteria
Inclusion Criteria for Plasma Exchange-Treated Patients:
1. Adult (≥18 years old)
2. Either a new diagnosis of multiple myeloma confirmed by bone marrow plasmayctosis \>10% or acute relapse of multiple myeloma
3. Light chain cast nephropathy, with involved light chain \>500 mg/L
4. 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).
5. Treated with at least 1 round of plasma exchange within 30 days of diagnosis of cast nephropathy
6. Treated with plasma exchange in 2010 or later
Inclusion Criteria for Control Patients:
1. Adult (≥18 years old)
2. Either a new diagnosis of multiple myeloma confirmed by bone marrow plasmayctosis \>10% or acute relapse of multiple myeloma
3. Light chain cast nephropathy, with involved light chain \>500 mg/L
4. 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:
1. Patients with end stage kidney disease
2. Patients with amyloidosis or monoclonal immunoglobulin deposition disease
3. Patients with chronic lymphocytic leukemia, plasma cell leukemia, or Waldenstrom's
4. Moribund condition (e.g., patients who died within 48 hours of initiation of plasma exchange)
5. Active urinary tract obstruction on renal imaging
6. Patients with significant albuminuria (≥2+ on urinary dipstick or \>10% fraction on UPEP)
7. Patients with other biopsy-proven causes of AKI (non-cast nephropathy lesions)
8. Patients who did not receive clone-directed therapy for myeloma
9. Patients who received plasma exchange \>30 days from the time of diagnosis of cast nephropathy
Source: ClinicalTrials.gov (NCT06483139). StuddyBuddy aggregates publicly available trial information.