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Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 56% 27 → 12 participants
See other at-risk trials from Columbia University

Record History

  1. Enrollment reduced: 27 → 12 participants Trial status changed: Recruiting → Active, Not Recruiting · Primary completion moved earlier from Apr 2026 to Oct 23, 2025 · Completion pushed from Jun 2026 to Feb 2027 · 1 morev9 Show 4 more changesShow less
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Primary completion moved earlier from Apr 2026 to Oct 23, 2025
    • Completion pushed from Jun 2026 to Feb 2027
    • Site details revised at 2 of 2 sites
  2. Primary completion date: Apr 2025 to Apr 2026 Completion date: Jun 2025 to Jun 2026v8 Show 1 more changeShow less
    • Completion date: Jun 2025 to Jun 2026
  3. Re-verified, no change to tracked fieldsv7
  4. Primary completion date: Apr 2023 to Apr 2025 Completion date: Jun 2023 to Jun 2025v6 Show 1 more changeShow less
    • Completion date: Jun 2023 to Jun 2025
  5. Study sites revised (2)v5 See this version in full on ClinicalTrials.gov ↗
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 2021 to Jun 8, 2021 · Site details revised at 2 of 2 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of Nov 2021 to Jun 8, 2021
    • Site details revised at 2 of 2 sites
  2. Primary completion date: Apr 1, 2021 to Apr 2023 Start date: Feb 10, 2021 to Nov 2021 · Completion date: Jun 1, 2021 to Jun 2023v3 Show 2 more changesShow less
    • Start date: Feb 10, 2021 to Nov 2021
    • Completion date: Jun 1, 2021 to Jun 2023
  3. Start date: Nov 30, 2020 to Feb 10, 2021v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to see whether Isatuximab can help improve kidney function of participants with MGRS. Isatuximab is approved by the Food and Drug Administration (FDA) for the treatment of adult patients with multiple myeloma, but it is not approved by the FDA to treat MGRS. This means that the use of isatuximab in this study is considered 'investigational'.
Trial Details
NCT Number NCT04614558
Lead Sponsor Columbia University
Collaborators: Genzyme, a Sanofi Company
Conditions Monoclonal Gammopathy
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov