Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Patients treated with plasma exchange Treated with plasma exchange ithin 30 days of diagnosis of light chain cast nephropathy
  • 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
Patients not treated with plasma exchange Patients not treated with plasma exchange within 30 days of diagnosis of light chain cast nephropathy
Patients treated with daratumumab Patients 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
Patients not treated with daratumumab Patients treated with daratumumab within 30 days of diagnosis of light chain cast nephropathy

Recruiting Locations

Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02130
Contact:
Shruti Gupta

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Shruti Gupta, MD
5712366626
sgupta21@bwh.harvard.edu

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, we will collect data on at least 150 patients treated with plasma exchange along with 300 control patients not treated with plasma exchange. Objective 2: We will compare renal outcomes among patients with light chain cast nephropathy and AKI treated with plasma exchange (n=150) versus daratumumab based regimen (eg Dara-CyborD) (n=150) versus other novel regimens (e.g., CyborD or another non-daratumumab-based regimen) (n=150). We will examine whether patients who receive dara-based regimens are more likely to have renal recovery compared to patients who do not receive dara-based regimens and to patients who receive plasma exchange. Given the infrequency with which plasma exchange is performed on a single-center level, we will compare outcomes among patients treated with plasma exchange, utilizing data from the multicenter study to those patients who were treated with daratumumab-based regimens without plasma exchange versus non- daratumumab-based regimen.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.