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A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma

Study acronym: TRI Pro
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Primary endpoints: details revised at 1 of 1 entry · Trial sites expanded: 9 → 38 locations · Eligibility criteria shortened, about 22 words · 1 more Show 4 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Trial sites expanded: 9 → 38 locations
    • Eligibility criteria shortened, about 22 words
    • Secondary endpoints: 17 to 14
  2. Trial sites expanded: 4 → 9 locations Completion date: Dec 2, 2030 to Nov 8, 2030v5 Show 1 more changeShow less
    • Completion date: Dec 2, 2030 to Nov 8, 2030
  3. Trial sites expanded: 1 → 4 locations Completion date: Nov 8, 2030 to Dec 2, 2030 · Start date changed from estimate of Jul 20, 2026 to Jun 30, 2026v4 Show 2 more changesShow less
    • Completion date: Nov 8, 2030 to Dec 2, 2030
    • Start date changed from estimate of Jul 20, 2026 to Jun 30, 2026
  4. Recruitment opened Study sites: 0 to 1v3 Show 1 more changeShow less
    • Study sites: 0 to 1
  5. Re-verified, no change to tracked fieldsv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 find out whether giving a single dose of tocilizumab before treatment with ramantamig can help prevent or reduce the severity of cytokine release syndrome (CRS) within 28 days from ramantamig, compared to participants who receive placebo. CRS is an acute inflammatory reaction that can occur during treatment and may be associated with flu-like or other systemic symptoms, such as fever and tiredness.
Trial Details
NCT Number NCT07589634
Lead Sponsor Janssen Research & Development, LLC
Conditions Multiple Myeloma
Enrollment 230 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov