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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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

Locations (1)

Brigham and Women's Hospital
Boston, Massachusetts, United States