Improving kidney outcomes in patients with light chain cast nephropathy

The Effect of Novel Treatments in Improving Renal Outcomes Among Patients With Light Chain Cast Nephropathy

This study is testing if plasma exchange can help improve kidney recovery in patients with light chain cast nephropathy compared to those who don't receive this treatment.

Quick facts

• Study type: Observational
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Brigham and Women's Hospital (other)
• Drugs / interventions: daratumumab
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06483139 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of plasma exchange in enhancing renal recovery in patients suffering from light chain cast nephropathy. It will collect data from at least 150 patients treated with plasma exchange and compare their renal outcomes to 300 control patients who did not receive this treatment. Additionally, the study will assess renal recovery among patients treated with daratumumab-based regimens versus those on non-daratumumab-based regimens. The multicenter approach allows for a comprehensive analysis of treatment outcomes across various institutions.

Who should consider this trial

Good fit: Ideal candidates include adults with a new diagnosis or relapse of multiple myeloma, light chain cast nephropathy, and acute kidney injury.

Not a fit: Patients who do not have light chain cast nephropathy or acute kidney injury may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved kidney recovery strategies for patients with light chain cast nephropathy.

How similar studies have performed: Other studies have shown promise in using plasma exchange for renal recovery, but this specific comparison with daratumumab-based regimens is novel.

Eligibility criteria

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

Where this trial is running

Boston, Massachusetts

• Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Shruti Gupta, MD — Brigham and Women's Hospital
• Study coordinator: Shruti Gupta, MD

Conditions: Multiple Myeloma, Light Chain Nephropathy, Acute Kidney Injury