Actively Recruiting
Novel Treatments in Improving Renal Outcomes in Light Chain Cast Nephropathy
Led by Brigham and Women's Hospital · Updated on 2025-11-19
450
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
J
Janssen, LP
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Novel Treatments in Improving Renal Outcomes in Light Chain Cast Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- New diagnosis or acute relapse of multiple myeloma confirmed by bone marrow plasmacytosis greater than 10%
- Light chain cast nephropathy with involved light chain levels above 500 mg/L
- Acute kidney injury defined as at least a 1.5-fold increase in serum creatinine from baseline or need for renal replacement therapy
- For plasma exchange group: received at least one round of plasma exchange within 30 days of diagnosis and treated in 2010 or later
- For control group: did not receive plasma exchange within 30 days of diagnosis
You will not qualify if you...
- Patients with end stage kidney disease
- Patients diagnosed with amyloidosis or monoclonal immunoglobulin deposition disease
- Patients with chronic lymphocytic leukemia, plasma cell leukemia, or Waldenstrom's disease
- Patients in moribund condition, such as those who died within 48 hours of starting plasma exchange
- Active urinary tract obstruction seen on kidney imaging
- Significant albuminuria defined as 2+ or higher on urine dipstick or over 10% fraction on urine protein electrophoresis
- Patients with other biopsy-confirmed causes of acute kidney injury besides cast nephropathy
- Patients who did not receive clone-directed therapy for myeloma
- Patients who received plasma exchange more than 30 days after diagnosis of cast nephropathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02130
Actively Recruiting
Research Team
S
Shruti Gupta, MD
CONTACT
C
Christina Shincovich, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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