Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06483139

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02130

Actively Recruiting

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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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Novel Treatments in Improving Renal Outcomes in Light Chain Cast Nephropathy | DecenTrialz