Phase
Condition
Bone Neoplasm
Bone Diseases
Lymphoproliferative Disorders
Treatment
Plasma exchange
Daratumumab
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
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
Study Design
Study Description
Connect with a study center
Brigham and Women's Hospital
Boston, Massachusetts 02130
United StatesActive - Recruiting
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