Novel Treatments in Improving Renal Outcomes in Light Chain Cast Nephropathy
NCT ID: NCT06483139
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
450 participants
OBSERVATIONAL
2024-06-01
2026-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Patients treated with plasma exchange
Treated with plasma exchange ithin 30 days of diagnosis of light chain cast nephropathy
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
No interventions assigned to this group
Patients treated with daratumumab
Patients treated with daratumumab within 30 days of diagnosis of light chain cast nephropathy
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
No interventions assigned to this group
Interventions
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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
Daratumumab
Patients treated with daratumumab within 30 days of diagnosis of light chain cast nephropathy
Eligibility Criteria
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Inclusion Criteria
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
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
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
18 Years
ALL
Yes
Sponsors
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Janssen, LP
INDUSTRY
Baystate Health
OTHER
Boston Medical Center
OTHER
Dana-Farber Cancer Institute
OTHER
Massachusetts General Hospital
OTHER
Mayo Clinic
OTHER
M.D. Anderson Cancer Center
OTHER
Medical University of South Carolina
OTHER
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
Northwell Health
OTHER
Ochsner Health System
OTHER
Ohio State University
OTHER
Stanford University
OTHER
Texas Medical Center
UNKNOWN
Thomas Jefferson University
OTHER
University of Alabama at Birmingham
OTHER
University of California, Los Angeles
OTHER
University of Chicago
OTHER
University of Colorado Health
OTHER
University of Minnesota
OTHER
University of New Mexico
OTHER
University of Pennsylvania
OTHER
University of Pittsburgh
OTHER
University of Virginia
OTHER
University of Washington
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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Shruti Gupta
Associate Physician, Director of Onconephrology
Principal Investigators
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Shruti Gupta, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Shruti Gupta
Role: primary
Other Identifiers
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2021P002205
Identifier Type: -
Identifier Source: org_study_id
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